Conditions: Delay in Time to Lactogenesis Stage II
Keywords: lactation Depo Provera contraception
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: yes

Brief summary:
Investigators will conduct a randomized controlled trial (RCT) to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and long-term contraceptive use. Investigators will randomize approximately 429 adult women who have delivered a healthy, full-term infant at The Ohio State University Wexner Medical Center (OSUWMC), who intend to breastfeed for ≥6 months, and who want to use DMPA (Depo-Provera; Pfizer Corp.) Note that because of anticipated screening failures, investigators will enroll more than the number randomized (i.e., up to 800 women). Investigators will randomize women to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Note that postpartum patients at the study site do not receive DMPA before discharge as standard care. At enrollment, women will receive condom counseling and provision and referral for contraception at 12 weeks (intervention and placebo arms) or at 6 weeks postpartum (open control arm). Investigators will collect data on lactogenesis, infant feeding and growth, and contraception use during 12 follow-up months. Investigators conducted a pilot study (N=100) in the target population, which supports the feasibility of the current trial.

Detailed description:
Postpartum women often are inadequately protected against rapid repeat pregnancy. Ensuring adequate inter- birth intervals could prevent an estimated 9% of deaths worldwide among children less than 5 years of age. Intramuscular injectable depot medroxyprogesterone acetate (DMPA) is rapidly becoming the method of choice in some settings, including regions where high maternal and child mortality make birth spacing critical. DMPA possesses many advantages for postpartum contraception as compared to other methods. However, the World Health Organization (WHO) advises against use of progestin-only injectables during the first six weeks postpartum among breastfeeding women. In contrast, the Centers for Disease Control and Prevention (CDC) recommends that progestin-only injectables generally can be started immediately postpartum on the grounds that their known advantages, as a whole, outweigh their unknown risks. This inconsistency in guidance reflects the lack of high-quality data for making evidence-based decisions. Studies conducted, to date, have important limitations: short follow-up intervals, low power, lack of consistency in using sensitive and standardized assessments, and lack of randomized trials evaluating DMPA administration specifically in the immediate postpartum period. Investigators propose to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and on child development. We will conduct a randomized controlled trial of 429 adult women who have delivered a healthy, full-term infant, intend to breastfeed for ≥6 months, and want to use DMPA. Women will be randomized to receive within 48 hours of delivery: 1) DMPA ("intervention" arm), 2) placebo injection ("placebo" arm) or 3) no injection ("open control" arm). The first two arms will be blinded while the open control arm will be unblinded. Investigators will determine the effect of immediate postpartum initiation of DMPA on breastfeeding (Aim 1) and on contraception use (Aim 2). The proposed trial is innovative in use of 1) a randomized, partially-blinded design with sufficient power and follow up; 2) standardized, validated measures on lactation as well as breastfeeding and contraception behaviors; and 3) whole-body air displacement plethysmography to identify differences between arms in infant body composition. The findings of a pilot study in the target population support the feasibility of the proposed trial. Investigators expect the trial findings will permit the harmonization of the WHO and CDC guidance on the timing of DMPA initiation among breastfeeding women. This would have important implications for shaping global policy and practice worldwide, especially in settings where inadequate birth spacing contributes to high maternal and infant morbidity and mortality.

Arms:
arm 1: Intramuscular injectable depot medroxyprogesterone acetate (1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) provided within 48 hours of childbirth arm 2: 0.9% sodium chloride injection provided within 48 hours of childbirth arm 3: No intervention provided

Interventions: intervention 1: Depo-Provera Injectable Product intervention 2: Placebos
Intervention descriptions: intervention 1: Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth intervention 2: Placebos -- Shot administered within 48 hours of childbirth

Protocol document:
Prot_SAP_ICF_001.pdf: 
Postpartum Family Planning  
NCT03844633  
Unique Protocol ID: 2017H0445  
May 5, 2021 


 
 
Initiation of injectable contraception immediately postpartum  
among breastfeeding women 
 
Protocol 
 
 
 
May 5, 2021 
 
 
 
Collaborating institutions: 
The Ohio State University, College of Public Health 
The Ohio State University Wexner Medical Center (OSUWMC) and the Department of Obstetrics 
and Gynecology Clinical Trials Office (CTO) 
Emory University School of Medicine, Department of Obstetrics and Gynecology 
 
 
 
 
 
This document may contain confidential information. It is understood that persons to whom this 
information is disclosed will not disclose it further without permission from The Ohio State 
University unless such information is published or otherwise becomes public knowledge. 
 
 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 2 
Short study title: “Postpartum Family Planning” or “Postpartum FP” 
I. 
Background 
Ensuring adequate birth spacing could prevent an estimated 9% of deaths worldwide among 
children less than 5 years of age.1 Many women, though, are not protected against repeat 
pregnancy. An estimated 61% of women in their first year postpartum do not want a repeat 
pregnancy and yet are not using contraception.2 The lactational amenorrhea method is effective 
as temporary contraception for breastfeeding women,3 but its duration of protection varies 
substantially,4 and women often fail to start another method before fertility returns. Furthermore, 
many women do not adhere to their lactation intentions: in a U.S. study, almost one-third of 
women who stated an intention to breastfeed either did not start or stopped within 6 weeks of 
birth.5  
Intramuscular injectable depot medroxyprogesterone acetate (DMPA) is rapidly becoming the 
contraceptive of choice in some settings, including regions where high maternal and child 
mortality make birth spacing particularly critical.6,7 Advisable timing of DMPA initiation 
among breastfeeding mothers, though, is in dispute.8,9 Progestin potentially could interfere 
with lactogenesis, milk quality or supply, overall duration, or infant growth.10,11 While human 
studies have not identified substantial effects from this exposure on breastfeeding outcomes, 
they suffer from low power and various possible biases. Given the theoretical risks, the World 
Health Organization (WHO) advises against use of progestin-only injectables during the first six 
weeks post-partum among breastfeeding women.8 In contrast, in its guidance for the U.S., the 
Centers for Disease Control and Prevention (CDC) recommends that progestin-only injectables 
generally can be started immediately postpartum on the grounds that their known advantages, 
as a whole, outweigh their unknown risks.9 This inconsistency in guidance reflects the lack 
of high-quality data for making evidence-based decisions. 
Balancing theoretical risks of harm against known risks of rapid repeat pregnancy has led to 
contradictions in clinical guidance and practice. While U.S. guidelines permit immediate 
postpartum DPMA use among breast-feeding women, the practice often is restricted in clinical 
settings in the U.S. and globally due to concerns ungrounded in rigorous science.  
II. 
Study Summary 
We will conduct a randomized controlled trial (RCT) to evaluate the effects of immediate 
postpartum initiation of DMPA on breastfeeding and long-term contraceptive use. We will 
enroll approximately 800 adult women who have delivered a healthy, full-term infant at a 
participating hospital, who intend to breastfeed for ≥6 months, and who want to use DMPA 
(Depo-Provera; Pfizer Corp.) We will randomize women to receive within 48 hours of 
delivery: 1) DMPA (“intervention” arm), 2) placebo injection (“placebo” arm) or 3) no 
injection (“open control” arm). The first two arms will be blinded while the open control arm 
will be unblinded. Note that postpartum patients at the study site do not receive DMPA before 
discharge as standard care. At enrollment, women will receive condom counseling and 
provision and referral for contraception at 12 weeks (intervention and placebo arms) or at 6 
weeks postpartum (open control arm). We will collect data on lactogenesis, infant feeding and 
growth, and contraception use during 12 follow-up months. We conducted a pilot study (N=100) 
in the target population at OSU, which supports the feasibility of the current trial. 
III. 
Objectives 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 3 
Objective 1: To determine the effect of immediate postpartum initiation of DMPA on 
breastfeeding. We hypothesize that administration of DMPA immediately postpartum (i.e., 
before hospital discharge) will not impair breastfeeding compared to administration beginning at 
12 weeks post-delivery. To increase the likelihood of detecting a negative effect if one exists, we 
will evaluate the primary outcome, timing of lactogenesis stage II12 (onset of copious milk 
secretion, usually occurring within 96 hours postpartum), as well as a range of secondary 
outcomes: breastfeeding duration, perceived need for supplementation, use of supplementation, 
perceived adequacy of milk production, and infant anthropometric measures, including body 
composition with whole-body air displacement plethysmography (OSUWMC site only).13-15 
Sensitivity analysis will evaluate 1) excluding women in the open control arm and 2) determining 
whether the findings differ by race. 
Objective 2: To determine the effect of immediate postpartum initiation of DMPA on 
contraception use. We hypothesize that putative DMPA use (i.e., blinded assignment to 
intervention or placebo arms) will put women on a better trajectory of contraception use by 
intervening during a time when they likely are highly motivated to avoid pregnancy. In contrast, 
women who are assigned to start DMPA after a delay risk losing motivation to initiate use. To 
test this hypothesis, we will compare prevalence of use of a highly-effective contraceptive 
method at 12 months post-delivery between women in the intervention and placebo arms versus 
the open control arm. Secondary outcomes will include DMPA use at 12 months. Sensitivity 
analyses will evaluate 1) whether the findings differ by race and 2) whether the findings differ 
after restricting the intervention and placebo arms to the subset of women who believe that they 
were in the intervention arm. 
IV. 
Literature 
A. Literature in Support of Objective 1: The relationship between immediate postpartum 
initiation of DMPA and lactation.  
Because delayed lactogenesis stage II is associated with a range of poor breastfeeding 
outcomes (failure to initiate, reduced duration, and use of supplements),16-18 identifying any 
negative effect of progestin on lactogenesis would be important. In theory, progestin could 
inhibit the process.19,20 Production of progesterone by the adrenal glands, ovaries and placenta 
increases during pregnancy. Plasma progesterone levels do not decrease until after delivery of 
the placenta, after which time, levels decline rapidly, reaching follicular phase levels after 2-3 
days. This decline, along with decreased estrogen levels and infant suckling, is thought to 
trigger lactogenesis. Cases of placental retention, in which lactogenesis has been delayed up to 
three weeks,21 support this physiologic mechanism. Also, exogenous progesterone given 
around the expected parturition time in rats or after fetus removal in ewes inhibits milk secretion; 
in contrast, no inhibitory effect occurred in rat models when progesterone was given after the 
establishment of lactation.19,22,23 Note, though, that progesterone and the synthetic progestogen, 
medroxyprogesterone acetate, used in the contraceptive injectable are different compounds, 
which are known to produce different effects in women; thus, findings from trials on 
progesterone use in animals are suggestive but cannot be assumed to represent the 
effects of DMPA use in women. 
A recent systematic review found no RCTs in humans on the effect of immediate 
postpartum initiation of DMPA on lactation.10 Three RCTs compared immediate postpartum 
use of a progestin-only method other than DMPA with the initiation of the same or a different 
hormonal method later during the puerperium. The three trials made the following comparisons: 
etonogestrel implant used immediately postpartum versus DMPA at 6 weeks postpartum;24 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 4 
levonorgestrel IUD placed postplacentally versus at 6-8 weeks postpartum,25 and etonogestrel 
implant placed at 1-3 days versus at 4-8 weeks postpartum.26 Three additional RCTs compared 
initiation of a progestin-only method within 48 hours postpartum – norethisterone enanthate 
injectable,27 etonogestrel implant,28 or daily oral administration of 0.350 mg of norethindrone -- 
versus placebo.29 The trial of the levonorgestrel IUD did not find differences between study arms 
in breastfeeding initiation or continuation at 6-8 weeks but did find that the postplacental arm 
had less breastfeeding continuation at 6 months.25 The remaining five trials found no differences 
in lactation outcomes between groups.24,26-29 Overall, the six trials were small (20-166 
participants) and had short follow-up intervals (2-26 weeks). Consequently, evidence from the 
trials is insufficient for ruling out an inhibitory effect from progestin. Furthermore, the 
trials are non-informative regarding the effect of immediate initiation of DMPA 
specifically, as this involves a different type of progestin given through a different route of 
administration, and involving a larger loading dose of progestin. 
Non-randomized evidence regarding the effect of immediate postpartum DMPA exposure 
on lactation outcomes is inconclusive. Ten observational studies compared breastfeeding 
outcomes between women choosing to use DMPA starting within the first 6 weeks postpartum 
compared to women using another or no method.10 In six of these studies, the upper window for 
starting DMPA ranged from five days to four months postpartum.30-35 None of these studies 
found impaired lactation outcomes (and three found DMPA to be associated with increased 
breastfeeding duration).33-35 However, because women in the six studies received DMPA after 
the typical window for lactogenesis stage II, their findings do not shed light on the potential 
effects of DMPA initiated before hospital discharge. The remaining four observational studies 
evaluated the effects of earlier DMPA administration, specifically 1-2 days postpartum,36 within 
72 hours postpartum,37 or at the time of38 or before hospital discharge.5 These study findings 
were mixed in that early DMPA administration was associated with longer mean breastfeeding 
duration;36 with less breastfeeding continuation at four weeks7 or at three months;37 or with no 
difference in duration.38 Furthermore, these non-randomized studies do not support firm 
conclusions because 1) they did not control for potential confounders related to women 
choosing to start DMPA use, which could have introduced substantial bias, and 2) they did not 
employ standardized, validated outcomes. 
No study on DMPA use during breastfeeding has assessed infant adiposity, specifically, 
as part of a more comprehensive assessment of growth. Increased infant weight gain 
typically has been interpreted in the breastfeeding and DMPA literature as a positive outcome. 
However, early hormone exposure theoretically could promote adiposity at the expense of other 
growth, such as brain and lean mass.39 Also, excessively rapid infant weight gain, in general, is 
associated with lifetime cardiovascular risk and is an early indicator of obesity risk.40 Five cohort 
studies measured the effect of postpartum DMPA exposure on infant weight gain. The first study 
(N=331) comparing initiation of DMPA or norethisterone enanthate at either 7 or 42 days 
postpartum to a non-hormonal comparison arm found no difference between groups in infant 
weight gain in first three months.32 However, during months 4-6, infants in the two injectable 
arms had higher weight gain than those in the comparison arm. The four other non-randomized 
trials that evaluated infant growth found no difference in weight gain among breastfeeding 
infants of mothers using DMPA compared to infants in a comparison arm not using DMPA over 
six months,31 a mean of 18 months41 or 4.5 years,34 or a maximum of 17 years of postpartum 
follow up.42 Again, in these non-randomized studies the failure to control for important 
confounders related to women self-selecting use of DMPA precludes any firm conclusions. 
Furthermore, despite the assumption in these studies that increased weight gain is a positive 
outcome, the validity of this interpretation is unknown. By measuring adiposity, we will have a 
superior measure of the effect of the exposure. 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 5 
In summary, an inhibitory effect on breastfeeding from immediate postpartum 
administration of DMPA cannot be ruled out due to the lack of data from RCTs conducted 
in women, the failure to use validated measures of lactation and the reliance on crude 
measures of infant growth and adiposity. The data have important limitations: short 
follow-up intervals, low power, lack of consistency in using sensitive and standardized outcome 
measures, and the lack of RCTs evaluating DMPA administration specifically in the immediate 
postpartum period.43 
B. Literature in Support of Objective 2: The relationship between immediate postpartum 
initiation of DMPA and contraception use.  
Unmet need for contraception remains high among postpartum women. An analysis of 
Demographic and Health Surveys conducted in 21 low- or middle-income countries found that 
61% of postpartum women did not want to become pregnant in the next year but were not using 
contraception.2 Likewise, data from the 2006-2010 National Survey of Family Growth found that 
35% of pregnancies in the U.S. were conceived within 18 months of a previous birth,44 putting 
both the woman and fetus at risk of adverse perinatal outcomes.  
Interactions with the healthcare system around the time of childbirth could represent an 
important window for intervening as women often are highly motivated to initiate contraception 
use to prevent a closely-spaced, repeat birth. Consequently, the WHO recommends that 
postpartum women be offered contraceptive counseling and provision following delivery before 
discharge,45 and professional bodies in the U.S. (e.g., the American College of Obstetricians 
and Gynecologists and the American Academy of Pediatrics) advise that prenatal and 
postpartum care include discussion of contraceptive options and initiation of postpartum 
contraception.46 Prenatal and postnatal contraception counseling, though, often are not 
available or are not offered.47,48 Contraception counseling is particularly important for women 
who want to start a new method. Changing method type is common during the postpartum 
period, with women citing a desire for avoiding repeat births, having improved method reliability, 
or avoiding safety concerns for the mother or infant.49  
Interventions delivered immediately postpartum as well as integrating postpartum contraception 
counseling into immunization and child health services have been shown to increase 
postpartum contraception use.47,50 In contrast, recent Cochrane reviews revealed inconsistent 
evidence on whether providing counseling on postpartum contraception reduces unmet need or 
repeat pregnancy rates.51, 52 However, the quality of evidence on effectiveness of the 
interventions included in the Cochrane reviews was generally low, and the authors argued that 
more rigorous trials are needed to determine the effects of the timing and elements of 
postpartum contraception counseling on contraception use and unintended pregnancy rates.  
RCTs have shown that a “quick start” of combination hormonal contraception (i.e., starting on 
the day of the health care visit) can increase contraceptive use compared to the conventional 
start (i.e., delaying start until the beginning of the next menstrual cycle).53 The increase in 
contraception use from the quick start, though, appears to wane over time. However, these 
findings cannot be assumed to be informative as to the effects of proposed intervention. First, 
postpartum women could be expected to have different motivation to initiate contraception than 
a more general population of women. Furthermore, the quick start studies differed from the 
current trial in that women did not need to return for care to start their method. That is, they 
either initiated the combination oral contraception or the contraceptive patch immediately or 
were provided the method to take with them to start later. Finally, these studies did not involve 
the use of DMPA, which would have required the women assigned to the conventional start to 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 6 
have returned to the clinic for the method. Postpartum women have substantial new demands 
on their time that might make it especially difficult for them to return to a facility to obtain 
contraception during the early postpartum interval.  
To date, no RCTs have examined the effect of immediate postpartum provision of DMPA 
on contraception use. Administering the method at a time when women are highly motivated 
to avoid repeat pregnancy could help overcome any initial reluctance to start the method and 
could put women on a better trajectory of contraception use following delivery. While women 
often discontinue use of methods, including DMPA, a substantial proportion might be motivated 
to continue to use DMPA. On a population level, this could have huge implications for avoiding 
adverse consequences of repeat pregnancies. However, no evidence on this is available. 
C. Evidence from Preliminary Studies 
From September to November 2015, we conducted a pilot study at one of the sites for the 
current trial, namely, the Labor and Delivery Unit at OSUWMC.48 We interviewed, before their 
hospital discharge, 100 postpartum women in the target population (i.e., English-speaking 
women ≥18 years of age who delivered a term, healthy infant of ≥2500 grams and who intended 
to breastfeed for ≥6 months). Nineteen percent of survey participants stated that they would 
“definitely” or “probably” start DMPA before discharge if they were offered the opportunity. The 
most commonly cited reasons for unwillingness to join the hypothetical trial were the need for 
more information on DMPA and more time to consider their contraceptive plans. Although 
professional associations in the U.S. recommend that prenatal visits include contraceptive 
counseling,46 almost half (43%) of the participants in this preliminary survey reported not 
receiving such counseling during prenatal care. Concerns about potential effects of DMPA on 
lactation did not appear to factor into women’s willingness to use DMPA; among those not 
interested in starting DMPA, only 2% cited concerns about its effects on their breastfeeding 
infant. Patients also had limited knowledge regarding the methods that are recommended for 
use during the first six weeks postpartum while breastfeeding. Among women who indicated a 
willingness to immediately start DMPA, 94% reported being willing to participate in a 
hypothetical trial that involved completing questionnaires online, and 76% reported being 
“definitely” or “probably” willing to be randomized to start the method either before discharge or 
at a later time. Among respondents wanting to start DMPA but indicating a lack of willingness to 
join the hypothetical study, women cited barriers, such as inconvenient campus parking for 
returning for follow-up visits.  
Large numbers of eligible women are available to recruit for the current trial. A review of 
OSUWMC patient records revealed 3,929 uncomplicated deliveries of term, singleton infants of 
>2500 grams without any apparent health problems delivered to adult, English-speaking women 
during 2015. We previously found that 76% of English-speaking, adult women who delivered a 
singleton, live-born infant at OSUWMC during a five-month interval in 2011 intended to 
breastfeed their infant.54 This finding is consistent with a population-based survey in 2014-2015 
that found 78% of newborn infants in Ohio initiated breastfeeding.55 Thus, we estimate an 
annual expected caseload at the OSUWMC study site of 2,986-3,064 adult, English-speaking 
women who deliver a term, singleton, healthy infant of ≥2500 grams and who intend to 
breastfeed their infant. Over the planned 30 months of study enrollment, we would only need to 
enroll 5.6%-5.7% of eligible women in this group to meet the target sample size. Note that this is 
well below the 14.4% of breastfeeding women in the pilot study who wanted to immediately start 
DMPA and were willing to be randomized to the timing of initiation. Thus, preliminary data 
support the feasibility of the trial by demonstrating the adequacy of the patient caseload 
at the enrollment site, OSUWMC.  


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 7 
V. 
Procedures 
A. Overview 
We will conduct an RCT of 429 women and their infant per arm (Figure 1). We will promote the 
study and enroll eligible, consenting women 1) prenatally at the primary obstetrical facilities that 
refer to the study sites ) for delivery; 2) prenatally at pregnancy-related classes in the 
community or 3) postpartum at a participating hospital after their delivery and before their 
discharge. We will enroll approximately 800 women because we anticipate a high number of 
screening failures before randomization.  Our power is based on having approximately 143 
women-infant pairs randomized to each of the three arms. 
 
The study will be partially blinded: participants and study staff, including the study statistician, 
will be blinded as to the assignment for those in the intervention and placebo arms. In contrast, 
no one will be blinded as to assignment to the open control arm. (Note that it is not feasible to 
maintain blinding for the open control arm even among the data analysts given the planned 
grouping of the arms for the data analyses.) DMPA has a duration of protection of 12 weeks. 
Women in the intervention or placebo arm will be counseled to refrain from initiating hormonal 
contraception in the next 6 weeks and to refrain from initiating DMPA in the next 12 weeks. 
Study staff will use the “Contraceptive choice information sheet” to explain the contraceptive 
methods that participants can use depending on whether they are assigned to an arm that 
receives a shot or the arm that does not receive a shot. All participants will be counseled to use 
condoms post-delivery to avoid a repeat pregnancy (as they either received no shot or could 
have received a placebo shot). Participants will receive a supply of condoms for either 12 weeks 
(intervention or placebo arm) or 6 weeks (open control arm), and will be referred to receive 
DMPA at either 12 weeks (intervention or placebo arm) or 6 weeks post-delivery (open control 
arm).   
Data collection, which will occur at enrollment and through 12 months of follow up, will involve 1) 
questionnaires on demographics, characteristics and behaviors, lactogenesis, breastfeeding 
and contraception use and 2) infant anthropometric measures (Table 1). 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 8 
  
B. Study Population 
We will enroll a convenience sample of 800 women.  Women can enroll either prenatally or 
postpartum before their hospital discharge.   
To enroll prenatally, women need to meet the following eligibility criteria:  
1) 
Intend to deliver in the Labor and Delivery Unit at a participating ;  
2) 
Are ≥18 years of age;  
3) 
Speak English;  
4) 
Intend to breastfeed, or express milk for their infant, for ≥6 months;  
5) 
Do not want to become pregnant within the first 12 months after delivery;  
6) 
Want to start use of DMPA immediately after delivery before discharge; AND 
Table 1.  Data collection by objective, location, schedule and mode of collection, and 
compensation. 
Objective 
Data collection 
Location 
Schedule and mode of 
collection 
Compensation 
1,2 
Enrollment 
Questionnaire 
 
Participating 
hospital 
Self-administered within 48 
hrs of delivery 
$80 in cash at 
OSUWMC; $80 in 
electronic gift card at 
Emory-affiliated 
Hospital 
1 
Milk Let-Down 
Questionnaire 
Participating 
Hospital  / 
text, 
telephone, 
email 
Interviewer administered ≤3 
times daily in person at 
OSUWMC or Emory-
affiliated hospital, then daily 
via text, telephone or email 
during the first 7 days 
postpartum until 
lactogenesis stage II occurs 
One payment of $30 
in electronic gift card 
at all sites 
1,2 
Follow-up 
Questionnaire  
Online 
Self-administered at 1, 2, 4,  
6, 9 and 12 months. 
Questionnaires at 1, 6 and 
12 months include infant 
anthropometric measures* 
from well-child visit data  
$10 per interview  in 
electronic gift card at 
all sites 
1 
Infant adiposity 
(PEA POD) and 
other infant 
measures*† 
OSUWMC 
only 
Measured by trained study 
staff at 4 months of age 
$40 in gift card, a 
branded gift (e.g., a 
cell phone popsocket 
or a pen with light) 
worth less than 
$4.00, and 
either parking pass or  
transportation by cab 
to appointment 
OSUWMC = Ohio State University Wexner Medical Center; *Includes weight, length, head circumference; †Visit not 
completed by participants who delivered at an Emory-affiliated Hospital 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 9 
7) 
Intend to reside in Ohio for those who deliver at OSUWMC or intend to reside in 
Georgia for who deliver at an Emory-affiliated Hospital for the first 12 months after 
delivery. 
Women will be excluded if they have any contraindications to DMPA (per package insert), which 
consist of the following:  
8) 
Undiagnosed vaginal bleeding; 
9) 
Known or suspected malignancy of breast; 
10) Active thrombophlebitis, or current or past history of thromboembolic disorders, or 
cerebral vascular disease;  
11) Liver dysfunction or disease; OR 
12) Known hypersensitivity to Depo-Provera. 
Women who enroll prenatally will need to rescreen following delivery to confirm their eligibility. 
Women enrolling after delivery or who are rescreening will need to meet criteria 2-12 above as 
well as the following eligibility criteria:  
1) Are a postpartum patient in the Labor and Delivery Unit at OSUWMC or participating 
Emory-affiliated Hospital; AND 
2) Have delivered a term, singleton infant of ≥2500 grams without any apparent health 
concerns.  
C. Outcome Measures 
The primary outcome is time to lactogenesis stage II measured with participant reports. 
Chapman and Perez-Escamilla validated the accuracy of maternal perceptions of the timing of 
lactogenesis stage II, and we will adhere to their questions and methods.12 Immediately after 
enrollment, we will record whether women perceived that their milk “has come in” and, if so, we 
will capture this event to the estimated post-delivery hour. Participants will be re-asked (up to 3 
times daily in person during their hospital stay and then daily via their choice of text, telephone, 
or email after discharge) during the first 7 days postpartum until the event occurs.  
Secondary outcomes include 1) length of breastfeeding continuation, which has been negatively 
associated with both experiencing a delay in lactogenesis stage II and maternal perception of 
the adequacy of her milk production;74 2) perceived need for supplementation (any and timing); 
and 3) use of supplementation (any and timing). We will use established questions on 
breastfeeding (any and exclusive feeding) from the National Immunization Survey, which also 
are used on the Health and Nutrition Examination Survey (NHANES).75 
Table 2. Location for recruitment, screening and enrollment by 
prenatal and postpartum status and type of location 
Women 
Type of location 
Location 
Prenatal 
Prenatal care at primary 
obstetrical facilities that 
refer to a participating 
hospital for delivery 
• Hospital obstetrics-
gynecology outpatient clinic  
 
• Faculty practices  
 
• Primary One health centers 
 
Local classes for pregnant 
women in the community 
• Lactation, birthing and 
prenatal yoga classes 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 10 
Finally, secondary 
outcomes will 
include infant 
measures collected 
during the follow-up 
questionnaire (using 
maternal reports of 
data from well-child visits) and during the 4-month visit at OSUWMC. Participants enrolled at an 
Emory-affiliated hospital will not complete a 4-month visit because the site lacks the ADP 
system.  The latter will include the following: 1) percent fat mass (%FM) and fat-free mass 
(FFM%) measured using the validated, non-invasive whole-body air displacement 
plethysmography (ADP) system; 2) length with a SECA 416 digital infantometer; 3) head 
circumference with metric tape; 4) body weight with SECA 727 digital scale; and 5) skinfold with 
Holtain calipers. We will ensure consistently high-quality measurement by regular monitoring, 
assessing reliabilities, and refresher training. 
D. Detailed Study Procedures 
Recruitment. We will advertise the study to women in the community during their pregnancy 
and to postpartum women following delivery at the study site before their discharge (Table 2). 
This recruitment will use a motion graphic video, which can be accessed through women’s own 
electronic devices (see http://go.osu.edu/ppfpstudy).  Postpartum patients also can choose to 
watch the video through the MyChart Bedside tablets at OSUWMC or tablets at Emory-affiliated 
hospitals via a home screen icon for the video. The URL and QR code for the video are included 
on the study written materials (poster and brochure). The video describes the following to 
potential participants: 1) the risk of pregnancy following childbirth among women who are 
sexually active, but not using a modern contraceptive method, even if the woman is 
breastfeeding and menses has not yet resumed; 2) benefits of using DMPA to adequately space 
pregnancies for both maternal and infant health; and 3) overview of the trial.   
The approved MyChart message (see file “MyChart Message”) will be routed monthly to the 
subset of OSUWMC and Emory patients who are identified in a query through the Information 
Warehouse that fit the study inclusion criteria by an Honest Broker.  Specifically, the message 
will be sent only to patients of OSUWMC and participating Emory-affiliated hospitals who are 1) 
a living patient; 2) active MyChart user; 3) attended a patient visit within the past year; 4) 
currently pregnant; 5) expect to deliver at a participating hospital; and 6) have an estimated 
delivery date within the next month. 
These patients will receive an email notifying them that they have “A new research study to 
view” in their MyChart message file. Once they login to their secure MyChart they will be able to 
review the details of the message and express their interest or decline more information. A “yes” 
response will release their contact information to the researcher in IHIS.  If the volunteer clicks 
“no” or ignores the message, the researcher will not receive any information about the potential 
volunteer.  The list of MRNs (obtained through IW) will go directly to Research IHIS team. The 
Research IHIS team will use the identified MRNs to send messages via MyChart. Only the 
Patients who said “Contact Me” (accepted) the medical record will be viewable by study team.  
Screening, enrollment and randomization. Study staff will use the “Eligibility Assessment 
Form” to screen pregnant and postpartum women who are recruited for the study to determine 
whether they meet the eligibility criteria.  
 
• Tour of study hospitals during 
pregnancy 
 
Through MyChart 
 
Postpartum 
Hospital 
• OSUWMC and participating 
Emory-affiliated hospitals 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 11 
If they have not already watched the recruitment video, eligible women will be given a tablet and 
headphones and asked to watch the video.  They then will be asked to read the “Combined 
Consent Form” in a private location. Women will indicate their agreement to participate in the 
study by signing the “Combined Consent Form.” Women will be given an unsigned copy of the 
“Combined Consent Form” to keep for future reference, as it provides contact information for 
staff responsible for the conduct of the research study in the event of any questions or 
concerns. 
If screening and signing of the “Combined Consent Form” occurs during the prenatal period, the 
participant will be rescreened – using the same “Eligibility Assessment Form” – after delivery 
before randomization. In this case, rescreening is to ensure that she meets the eligibility criteria 
before randomization.  
Randomization will occur after delivery (ideally within 48 hours) and before hospital discharge.  
Stratified randomization with random permuted blocks will be generated using the 
randomization function within the electronic data capture system, REDCap.73 This process 
serves to conceal the allocation process by automatically revealing the arm assignment only 
upon study enrollment. To minimize the potential for attrition or crossover between arms, 
participants who are randomized to the intervention or placebo arm will be administered their 
assigned shot (under blinded conditions) immediately after randomization. Research pharmacy 
staff will ensure the correct shot is given to the correct participant by checking the randomization 
documentation before dispensing. 
Participants will complete the “Enrollment Questionnaire” on demographics, reproductive 
history, attitudes and intentions on related topics including breastfeeding.  
Participants will be referred for DMPA at 12 weeks if in the intervention or placebo arms and at 
6 weeks if in the open control arm. Participants will receive referrals for financial assistance for 
DMPA as appropriate. Participants will be counseled to use condoms for all sexual intercourse 
before receiving DMPA and will receive a supply of condoms for 12 weeks (intervention or 
placebo arms) or 6 weeks (open control arm). Interviewers will administer the short “Milk Let-
Down Questionnaire” up to three times daily in person before discharge or until lactogenesis II 
occurs. 
Follow up. If lactogenesis II does not occur before hospital discharge, participants will be asked 
to complete the “Milk Let-Down Questionnaire” daily via telephone, text or email for the first 7 
days postpartum until the event occurs.    
Participants will be instructed to complete an online “Follow-up Questionnaire” at 1, 2, 4, 6, 9 
and 12 months post-delivery. The “Follow-up Questionnaire” will collect data on breastfeeding 
behaviors and perceptions; contraception use; and infant physical measurements from well-
child visits. If the participant does not have the information from her infant’s well-child visit on-
hand or if the information that she provides is incomplete or appears to be inaccurate, we will 
extract the data on the infant’s weight, length and head circumference from the medical records 
at their pediatrician’s office.   
Participants enrolled at OSUWMC will be asked to return with their infant to OSUWMC for a 
four-month visit, during which infant measures will be collected (infant adiposity via PEA POD, 
weight, length, head circumference and skinfold) and recorded on the “Four-month Visit Form.” 
If women have not already completed their 4-month online “Follow-up Questionnaire” at the time 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 12 
of the in-person visit, they will be instructed to do so using a 
computer established for this purpose at OSUWMC.  
Compensation. Participants will receive compensation 
(amounts specified in Table 1) for their time and travel 
expenses. The compensation amounts are in-line with recent 
research with similar populations. 
Blinding. Blinding of the investigational product is critical to the 
integrity of the study. Participants and study staff will be 
blinded to the study drug assignment to the intervention and 
placebo arms. The Investigational Drug Services (IDS) 
Pharmacy at the study sites will have responsibility for 
organizing the blinding and preparing the injections. The IDS 
Pharmacy provides support to clinical trials at the study site 
and operates in compliance with all relevant regulatory and 
institutional policies. An unblinded pharmacist will prepare the 
injections in such a way as to ensure the masking of the 
contents of the syringe. The three study arms will receive the 
following: 1) intervention arm will receive DMPA injection; 2) 
placebo arm will receive 0.9% sodium chloride injection; and 3) 
open control arm will receive no injection. After completion of 
randomization and treatment allocation, study medication (i.e., 
DMPA injection or 0.9% sodium chloride injection) will be 
withdrawn into a 1mL syringe. Syringes will be masked using 
amber tinted tape to ensure blinding (see Figure 2).  
Data collection and management. All study data will be 
recorded into the PHI version of the electronic data capture 
system, REDCap.73 Supported by the OSU Center for Clinical and Translational Science 
(CCTS), REDCap facilitates the transmittal of secure, encrypted and password-protected data. 
CCTS will program the data entry screens (with audio component options for participant-
administered questionnaires), implementing built-in skip patterns and quality control checks. 
Data will be instantaneously uploaded behind the secure OSU firewall. The PI will monitor data 
during the study to resolve potential issues upon detection.  
Participants’ privacy and the confidentiality of data will be protected through training of 
interviewers and other study staff; conducting all interviewing, and physical examinations in 
private; storing study materials in a locked room; and securing computer files that include 
identifiers.  The linkage between the PINs and the participants’ identifying information will be 
maintained in a REDCap form. Otherwise, only the study PINs will identify participant research 
records.  The form with the linkage between the PINs and the participants’ identifying 
information and all other identifying information (e.g., signed consent forms) will be destroyed 
after the primary trial findings are published. Data identifying individual study participants will not 
be published or released to persons outside of the project. Non-identifiable study data will be 
retained for at least five years after study close-out. 
Minimizing attrition. We will implement strategies used by the study team in other studies that 
have achieved high retention of participants during follow up. These targeted efforts will include 
1) providing information to participants at each encounter about the importance of attending the 
scheduled study visits or completing the telephone or online questionnaires, 2) providing 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 13 
participants with appointment cards, 3) telephoning, emailing or texting participants 1-2 days 
before their upcoming data collection as a reminder or immediately after any missed follow up; 
4) streamlining procedures to allow participants to complete assessments quickly; and 5) 
keeping data collection instruments as concise as possible to avoid participant fatigue. We will 
request that participants provide multiple, acceptable methods for contacting them (updated, as 
needed, at each contact). Women who miss a rescheduled appointment will not be contacted 
again for the visit in case they have changed their mind about study participation.  
E. Statistical Considerations 
Analysis of Objective 1. A noninferiority analysis will be used for the primary outcome of time 
to lactogenesis II. Noninferiority trials are appropriate when the goal is to show that a new 
treatment (immediate postpartum DMPA initiation) is not clinically worse than an active control 
(placebo injection, open control); this is in contrast to the standard superiority trial, in which the 
goal is to show that a new treatment is better than the control. Noninferiority will be determined 
based on the relationship of two-sided 95% confidence intervals (CIs) to pre-specified 
noninferiority margins. Noninferiority of the intervention arm over the other two arms combined 
will be accepted if the upper bound of a two-sided 95% CI for the mean difference between 
groups (intervention – placebo and open control) is less than 6 hours. Although a clinical 
significant delay in lactogenesis has not been well established, this difference is conservatively 
sensitive for a noninferiority test given that many common medical interventions (e.g., epidural 
anesthesia, labor induction, and Cesarean delivery) have been shown to delay lactogenesis 
stage II by up to 12 hours.77 Furthermore, the interval of 6 hours is consistent with previous 
research.12 Sensitivity analysis will evaluate excluding women in the open control arm (i.e., 
comparing the intervention arm to the placebo arm). 
As a sensitivity analysis, we will repeat these analyses accounting for infant sex as a biological 
variable, as well as potential confounders including maternal factors that could affect 
lactogenesis: age, pre-pregnancy body mass index, primiparity, psychosocial stress, diabetes, 
hypertension, unscheduled Cesarean section, and intention at birth to exclusively.78-80 We also 
will evaluate whether the relationship of interest (e.g., immediate postpartum DMPA initiation 
and time to lactogenesis II) varies by maternal Black race. Finally, although we expect only a 
negligible amount of missing data for the primary outcome, we will assess the sensitivity of 
results to missing data by performing multiple imputation analyses under both missing at 
random and missing not at random assumptions. 
For secondary outcomes (breastfeeding duration, perceived adequacy of milk production, etc.), 
we do not have a priori set noninferiority margins, and thus a traditional superiority analysis will 
be conducted (test for significant differences using t-tests or chi-squared tests as appropriate). 
We will report two-sided 95% CIs for all outcomes so that post-hoc noninferiority analyses could 
be conducted (i.e., to evaluate whether the CI covers a specified noninferiority margin).  
Analysis of Objective 2. A traditional superiority analysis will be used to compare rates of use 
of a highly effective method of contraception (defined here as DMPA, implant, IUD, sterilization, 
pill, patch, or ring) at 12 months post-delivery among women in the intervention or placebo arm 
versus those in the open control arm. An intent-to-treat analysis will be conducted using a chi-
squared test to compare the percentages of women using contraception in each group 
(intervention + placebo versus open control). As a sensitivity analysis, we will repeat this 
analysis using logistic regression in order to account for potential confounders such as maternal 
age, parity, gravidity, socioeconomic status, sexual activity, and prior contraceptive history. We 
will also repeat analyses restricting those in the intervention or placebo arm to the subset of 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 14 
women who believe that they received DMPA at enrollment regardless of the accuracy of their 
belief as an additional sensitivity analysis. Furthermore, we will evaluate whether the 
relationship between immediate postpartum DMPA initiation and contraception use at 12 
months differs by maternal Black race. 
Given that the contraception use outcome is measured at 12 months, we anticipate some 
missing data; however, we have no reason to believe dropout will be differential across arms. 
Thus, we will assess sensitivity of results to missing data using multiple imputation analyses 
under both missing at random and missing not at random assumptions. The secondary outcome 
(DMPA use at 12 months) will be analyzed with similar methods.  
Sample size. Sample size was based on providing high (90%) power for the primary outcome 
of Objective 1 (time to lactogenesis II), while also ensuring appropriate power for Objective 2. 
We assumed that all groups would have a mean of 65 hours with a common standard deviation 
of 18 hours, based on a previous study,26 which was consistent with past research.19,20 Setting 
the noninferiority margin at 6 additional hours, with a type 1 error rate of 0.05 (two-sided 95% 
CI), we require 143 women randomized to each group to achieve 90% power. As this 
outcome is measured very soon after randomization, we expect to have it measured on all 
randomized women. However, we note that even if we have a small amount of missing data for 
this outcome, we will still have high power. For example, if we have 10% missing data (i.e., time 
to lactogenesis II measured on 128 women per group), we will still have 87% power. 
Additionally, this sample size ensures adequate power for our sensitivity analysis comparing 
intervention to placebo (i.e., excluding women in the open control arm); we will have 80% power 
for the noninferiority analysis comparing these two groups (under the same assumptions as 
stated above). 
The sample size justified for Objective 1 also will provide high power for Objective 2, which will 
be assessed using traditional superiority analyses. Based on a recent analysis of data from the 
National Survey of Family Growth,81 we assume that the rate of highly effective contraceptive 
use will be 50% in the open control arm. We conservatively assume a 20% attrition rate at 12 
months, thus will have n=114 women in the open control arm and n=228 women in the 
combined injection arms (DMPA; placebo). With this sample size of randomized women, we will 
have 81% power to detect a contraceptive use rate of 66% in the intervention/placebo group, 
corresponding to a relative risk of RR=1.32. 
VI. 
Ethical Considerations 
 
A. Potential Risks 
This study poses no more than minimal risk to participants. Participants may experience 
psychological risks associated with answering questions about sensitive topics or reporting 
attitudes and behaviors, such as their contraception use. 
The study intervention under evaluation (i.e., administration of DMPA for contraception within 48 
hours of delivery among women intending to breastfeed their infants) is not contraindicated per 
the medical eligibility criteria for contraception use issued by the U.S. Centers for Disease 
Control and Prevention.9 However, while clinical practices often provide DMPA to breastfeeding 
women, many settings – including the study site – do not routinely offer DMPA to this group 
during the immediate postpartum period. Thus, the current trial is warranted to address the gap 
between U.S. guidelines and routine clinical practice. The trial design is ethical given that the 
U.S. guidelines permit immediate initiation of DMPA among breastfeeding women. Furthermore, 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 15 
IRBs have approved the conduct of trials involving randomizing women to start contraception at 
different times with condoms provided for use in the interim (see our trial approved by the CDC 
IRB56 as well as other examples.)57,58 
We will not perform any genetic testing. 
B. Protections Against Risk 
Several measures have been implemented to minimize the risks to individuals from trial 
participation. First, during the consent process, women will be advised that they are free to 
decline study participation and that they can decline to participate without affecting their care at 
the facility. Participants also will be informed that if they are uncomfortable at any time, they can 
decline to answer any questions, participate in any study activity, or discuss any topic. If 
indicated, participants will be referred for counseling services. 
Participants also will be informed of their freedom to terminate the interview or visit at any time 
without affecting their routine heath care at the facility. All interviews will take place in a private 
setting by interviewers who have been trained thoroughly on the importance of confidentiality, 
the procedures to protect a participant’s confidentiality, and the penalties associated with 
breaches of confidentiality.  
Participants’ personal information will be kept confidential. Access to the roster with identifiers 
will be limited to authorized study personnel. Participants’ privacy and the confidentiality of data 
will be protected through training of interviewers and other study staff; conducting all 
interviewing in private; storing study materials in a locked room when not in use; and securing 
computer files that include identifiers or study data. A unique code will be used to identify the 
participant’s study records. The linkage between the PINs and the participants’ identifying 
information will be maintained in a REDCap form. These linkages will be destroyed after the 
primary study findings have been published.  
C. Potential Benefits of the Research to Human Subjects and Others 
The trial provides no direct benefits to the research participants. Participants and others may 
indirectly benefit in the future if the trial shows no difference in immediate initiation of DMPA 
compared to initiation at 6 weeks postpartum in terms of the effects on breastfeeding and infant 
development. 
The potential risks involved in trial participation are reasonable in relation to the anticipated 
benefits. 
D. Importance of the Knowledge To Be Gained 
The research will provide important information on the effects of immediate postpartum initiation 
of DMPA among breastfeeding mothers and their infants. 
E. Incidents and Incident Reporting  
Study staff will record information on any adverse events (AEs) that are classified 1) as 
possibly, probably, or definitely related to study participation and as unexpected or 2) as 
serious. Adverse events (AEs) are defined as any untoward health-related reaction, effect, 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 16 
toxicity, or abnormal laboratory result that a study participant experiences during the course of a 
study that is new or a worsening of a baseline condition. 
An unexpected AE is one whose specificity or severity is not listed in the DMPA package insert 
(i.e., bleeding irregularities, bone mineral density changes, cancer risks, thromboembolic 
disorders, ocular disorders, ectopic pregnancy, and anaphylaxis). Information on expected AEs 
will be recorded on study data collection forms, but these events will not be reported to the 
relevant IRBs and NIH unless the event is also serious or is an unanticipated problem involving 
risks to subjects or others (UPIRTSO). 
An AE is considered serious if it is fatal or life-threatening, requires in-patient hospitalization or 
prolongation of an existing hospitalization, results in a persistent or significant disability or 
incapacity, is a congenital anomaly or birth defect, jeopardizes the participant or requires 
intervention to prevent one of the outcomes listed above, or any other event deemed serious by 
the investigator. Study personnel will report any AE to the PI, who will determine 1) its 
relatedness to study participation and 2) its seriousness. 
All serious adverse events (SAEs) will be reported in an expedited manner to the PI. If it is 
determined that the SAE is unanticipated and anything other than “not related” (i.e., possibly, 
probably or definitely related), then the PI, or designee, will notify the IRBs of record and the 
NIH of the event. Non-serious AEs will be recorded on data collection forms but do not require 
expedited reporting unless they are classified as UPIRTSO. 
UPIRTSO are any events or information that were unexpected and indicate that research 
procedures caused harm to participants or others or indicate that participants or others are at 
increased risk of harm. An unanticipated problem may involve any aspect of the research study 
and could involve anyone including participants, research staff, or others not directly related to 
the study. AEs that are unexpected and related and protocol violations are specific examples of 
UPIRTSO. (Not all AEs are UPIRTSO, and not all UPIRTSO are AEs.) Examples of other 
UPIRTSO include 1) a breach of confidentiality; 2) a change to the protocol taken without prior 
IRB review to eliminate an apparent immediate hazard to a research participant; 3) halting of the 
study by a sponsoring agency; and 4) a participant complaint that indicates unexpected risks or 
that cannot be resolved by the study team. Any possible UPIRTSO will be recorded on the 
appropriate log and report form. The PI will decide whether the incident meets the definition of 
UPIRTSO and, thus, requires prompt reporting to the IRBs and NIH. 
All adverse events will be managed according to the standard of care for the clinical practice 
and the judgment of the on-site clinicians. 
F. Data Safety and Monitoring Plan 
The Regulatory and Ethics Core of The Center for Clinical and Translational Science 
(CCTS) at OSU will assemble a Data Safety Monitoring Committee (DSMC) – consisting at 
minimum of a research ethicist / research subject advocate, biostatistician, and 
obstetrician-gynecologist – to independently monitor the safety of the study.  The DSMC 
will be chaired by Dr. Michael Para, who is Professor in the Department of Internal Medicine 
at OSU and the Director of the Regulatory Program at CCTS.  The DSMC will convene before 
study initiation and, during this initial meeting, the DSMC will provide recommendations 
regarding the protocol application and will develop and approve the DSMC Charter for the trial. 
After trial initiation, the DSMC will review the accumulated data after an initial subset of 
participants have been enrolled and after half of the participants have been enrolled. The DSMC 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 17 
will evaluate participant safety and study conduct and progress and will make recommendations 
to the sponsor and investigators concerning the trial continuation, modification or termination. 
No specific stopping guidelines will be presented with the data, and stopping early for safety 
reasons will be based on the judgment of the DSMC.  
VII. Protocol Registration 
We will prospectively register the trial at the Protocol Registration System 
(www.clinicaltrials.gov) before enrolling any subjects. 
VIII. Internal Validity 
A primary limitation of the trial involves potential issues of generalizability. For example, we are 
restricting the study to exclude infants who are preterm, low birthweight, or have apparent 
health complications. Consequently, our findings cannot be extended to infant subgroups 
arguably most in need of the intervention. Although breastfeeding could be especially important 
for these subgroups, their inclusion could hinder our ability to detect differences attributable to 
DMPA exposure. A future study would focus on these special groups. Another potential issue is 
the linkage, albeit controversial, between DMPA and increased risk of HIV acquisition found in 
non-randomized trials.82,83 However, even if the ongoing RCT eventually supports a causal 
relationship,84 DMPA is a popular method that can be expected to continue to have an important 
role in the contraception method mix.  
The trial will not answer other research questions that may be of interest. For example, we will 
not evaluate whether early administration of DMPA affects milk composition. Prior assessments 
have been unable to interpret the clinical significance of any difference detected in milk 
composition. For this reason, we are focusing on outcomes with clearer clinical significance. 
While other breastfeeding outcomes are important to maternal and infant health, we selected 
the primary outcome, timing of lactogenesis stage II, because it is closely tied to the possible 
mechanism by which DMPA exposure could impair lactation. Furthermore, this outcome is less 
susceptible to bias than other possible breastfeeding outcomes. For example, breastfeeding 
duration could be biased if even a minor proportion of participant attrition occurs during follow 
up and if this attrition were differential by study arm.  
We could experience logistical challenges while fielding the trial. We plan to randomize women 
within 48 hours of delivery. However, to reflect real-life, clinical circumstances, we will 
randomize women within 96 hours of delivery, if needed. In this case, we would conduct 
sensitivity analyses to determine whether the timing of the initial DPMA injection affects the 
primary outcomes.  
We will implement strategies to maximize study retention that has been effective in our previous 
clinical trials. These include collecting (and routinely confirming) detailed contact information to 
generate follow-up reminders about study activities and visits; conducting contact tracing of 
participants who fail to complete on-line questionnaires or the in-person 4-month visit; providing 
the option of completing the questionnaire via telephone for any participant who prefers this 
mode for any reason (e.g., lack of internet access); streamlining procedures to allow participants 
to complete follow-up assessments quickly; designing data collection instruments to be as 
concise as possible so as to not overburden the participants and thereby increase the risk of 
response error; and providing payments to compensate for time and travel costs incurred by the 
participants. 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 18 
IX. 
Conclusion 
An estimated 135 million women give birth annually85 and have to decide on contraception to 
avoid a closely-spaced repeat pregnancy. DMPA is the most popular contraceptive method in 
some regions, including those in which poor birth spacing contributes to high maternal and 
infant mortality.7 However, we lack evidence on the effects of its immediate postpartum use 
among breastfeeding women. This gap in evidence has led to the WHO and CDC issuing 
inconsistent recommendations,8,9 and women having to make a decision regarding initiating 
contraception postpartum without the information necessary to inform their choice. 
We expect the trial findings will permit the harmonization of the WHO and CDC guidance on the 
timing of DMPA initiation among breastfeeding women.8,9 The trial findings will be used to 
directly inform policy and practice in both the U.S. and globally, including in settings where 
inadequate birth spacing contributes to high maternal and infant mortality. 
X. 
Timeline  
Table 3.  Project timeline 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 19 
 
XI. 
References 
 
1. 
World Health Organization. Report of a WHO technical consultation on birth spacing, 
Geneva, Switzerland, 13-15 June 2005. Geneva: WHO, 2006. 
2. 
Moore Z, Pfitzer A, Gubin R, Charurat E, Elliott L, Croft T. Missed opportunities for family 
planning: an analysis of pregnancy risk and contraceptive method use among postpartum 
women in 21 low- and middle-income countries. Contraception 2015,92:31–3. 
3. 
Trussell J. Contraceptive failure in the United States. Contraception 2011;83:397-404. 
4. 
Prieto CR, Cardenas H, Croxatto HB. Variability of breast sucking, associated milk transfer 
and the duration of lactational amenorrhoea. J Reprod Fertil 1999;115:193-200. 
5. 
Halderman LD, Nelson AL. Impact of early postpartum administration of progestin-only 
hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-
feeding patterns. Am J Obstet Gynecol 2002;186:1250-6. 
6. 
Ross JA, Agwanda AT. Increased use of injectable contraception in sub-Saharan Africa. Afr 
J Reprod Health 2012;16:68-80. 
7. 
United Nations Department of Economic and Social Affairs. Trends in contraceptive 
methods used worldwide. Population Facts No. 2013/9, December 2013. 
8. 
World Health Organization Reproductive Health and Research. Medical eligibility criteria for 
contraceptive use. 5th edition. Geneva: WHO, 2015. Available at 
http://www.who.int/reproductivehealth/publications/family_planning/MEC-5/en/  
9. 
Centers for Disease Control and Prevention. Update to CDC's U.S. medical eligibility 
criteria for contraceptive use, 2010: revised recommendations for the use of contraceptive 
methods during the postpartum period. MMWR Morb Mortal Wkly Rep 2011;60:878-83. 
Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6026a3.htm  
10. Phillips SJ, Teppers NK, Kapp N, Nanda K, Temmerman M, Curtis KM. Progestogen-only 
contraceptive use among breastfeeding women: a systematic review. Contraception 
2016;94:226-52. 
11. Lopez LM, Grey TW, Stuebe AM, Chen M, Truitt ST, Gallo MF. Combined hormonal versus 
nonhormonal versus progestin-only contraception in lactation. Cochrane Database Syst 
Rev 2015;3:CD003988.  
12. Chapman DJ, Pérez-Escamilla R. Maternal perception of the onset of lactation is a valid, 
public health indicator of lactogenesis stage II. J Nutr 2000;130:2972-80. 
13. Yao M, Nommsen-Rivers L, Dewey KG, Urlando A. Preliminary evaluation of a new 
pediatric air displacement plethysmograph for body composition assessment in infants. 
Acta Diabetol 2003;40:S55-8. 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 20 
14. Ma G, Yao M, Liu Y, Lin A, Zou H, Urlando A, et al. Validation of a new pediatric air-
displacement plethysmograph for assessing body composition in infants. Am J Clin Nutr 
2004;79:653-60. 
15. Ellis KJ, Yao M, Shypailo RJ, Urlando A, Wong WW, Heird WC. Body-composition 
assessment in infancy: air-displacement plethysmography compared with a reference 4-
compartment model. Am J Clin Nutr 2007;85:90-5. 
16. Brownell E, Howard CR, Lawrence RA, Dozier AM. Delayed onset lactogenesis II predicts 
the cessation of any or exclusive breastfeeding. J Pediatr 2012;161:608-14.  
17. Chapman DJ, Perez-Escamilla R. Does delayed perception of the onset of lactation shorten 
breastfeeding duration? J Hum Lact 1999;15:107–11.  
18. Hruschka DJ, Sellen DW, Stein AD, Martorell R. Delayed onset of lactation and risk of 
ending full breast-feeding early in rural Guatemala. J Nutr.2003;133:2592–9. 
19. Cowie AT, Forsyth IA, Hart IC. Hormonal control of lactation. Berlin: Springer-Verlag, 1980, 
164-5. 
20. Darney P, Speroff L. A clinical guide for contraception. 4th ed. Philadelphia: Lippincott 
Williams & Wilkins, 2005. 
21. Neifert MR, McDonough SL, Neville MC. Failure of lactogenesis associated with placental 
retention. Am J Obstet Gynecol 1981;140:477-8. 
22. Mepham TB. Physiology of lactation. Oxford: Oxford University Press, 1987. 
23. Hartmann P, Trevethan P, Shelton JN. Progesterone and oestrogen and the initiation of 
lactation in ewes. J Endocrinol 1973;59:249-59. 
24. Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sá MF, Vieira CS. Safety of the 
etonogestrel-releasing implant during the immediate postpartum period: a pilot study. 
Contraception 2009;80:519-26. 
25. Chen BA, Reeves MF, Creinin MD, Schwarz EB. Postplacental or delayed levonorgestrel 
intrauterine device insertion and breast-feeding duration. Contraception 2011;84:499-504. 
26. Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. Lactogenesis after 
early postpartum use of the contraceptive implant: a randomized controlled trial. Obstet 
Gynecol 2011;117:1114-21. 
27. Lawrie TA, Hofmeyr GJ, De Jager M, Berk M, Paiker J, Viljoen E. A double-blind 
randomised placebo controlled trial of postnatal norethisterone enanthate: the effect on 
postnatal depression and serum hormones. Br J Obstet Gynaecol 1998;105:1082-90. 
28. Braga GC, Ferriolli E, Quintana SM, Ferriani RA, Pfrimer K, Vieira CS. Immediate 
postpartum initiation of etonogestrel-releasing implant: A randomized controlled trial on 
breastfeeding impact. Contraception 2015;92:536-42.  
29. Giner Velazquez J, Cortes Gallegos V, Sotelo Lopez A, Bondani G. Effect of daily oral 
administration of 0.350 mg of norethindrone on lactation and on the composition of milk. 
Ginecol Obstet Mex 1976;40:31-9. 
30. Brownell EA, Fernandez ID, Fisher SG, Howard CR, Ternullo SR, Lawrence RA, et al. The 
effect of immediate postpartum depot medroxyprogesterone on early breastfeeding 
cessation. Contraception 2013;87:836-43. 
31. Singhal S, Sarda N, Gupta S, Goel S. Impact of injectable progestogen contraception in 
early puerperium on lactation and infant health. J Clin Diagn Res 2014;8:69-72. 
32. Karim M, Ammar R, el-Mahgoub S, el-Ganzoury B, Fikri F, Abdou I. Injected progestogen 
and lactation. Br Med J 1971;1:200-3. 
33. Zañartu J, Aguilera E, Munoz G, Peliowsky H. Effect of a long-acting contraceptive 
progestogen on lactation and incidence of pregnancy. Obstet Gynecol 1976;47:174-6. 
34. Jimenez J, Ochoa M, Soler MP, Portales P. Long-term follow-up of children breast-fed by 
mothers receiving depot-medroxyprogesterone acetate. Contraception 1984;30:523-33. 
35. Zacharias S, Aguilera E, Assenzo JR, Zañartu J. Effects of hormonal and nonhormonal 
contraceptives on lactation and incidence of pregnancy. Contraception 1986;33:203-13. 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 21 
36. Guiloff E, Ibarra-Polo A, Zañartu J, Toscanini C, Mischler TW, Gómez-Rogers C. Effect of 
contraception on lactation. Am J Obstet Gynecol 1974;118:42-5. 
37. Matias SL, Nommsen-Rivers LA, Dewey KG. Determinants of exclusive breastfeeding in a 
cohort of primiparous periurban Peruvian mothers. J Hum Lact 2012;28:45-54. 
38. Hannon PR, Duggan AK, Serwint JR, Vogelhut JW, Witter F, DeAngelis C. The influence of 
medroxyprogesterone on the duration of breast-feeding in mothers in an urban community. 
Arch Pediatr Adolesc Med 1997;151:490-6. 
39. Belfort MB, Gillman MW, Buka SL, Casey PH, McCormick MC. Preterm infant linear growth 
and adiposity gain: trade-offs for later weight status and intelligence quotient. J Pediatr 
2013;163:1564-9.  
40. Barker DJ. The developmental origins of chronic adult disease. Acta Paediatr Suppl 
2004;93:26-33. 
41. Dahlberg K. Some effects of depo-medroxyprogesterone acetate (DMPA): observations in 
the nursing infant and in the long-term user. Int J Gynaecol Obstet 1982;20:43-8. 
42. Pardthaisong T, Yenchit C, Gray R. The long-term growth and development of children 
exposed to Depo-Provera during pregnancy or lactation. Contraception 1992;45:313-24. 
43. World Health Organization, Department of Reproductive Health and Research. 
Progestogen-only contraceptive use during lactation and its effects on the neonate. 
Geneva: WHO, 2008. 
44. Gemmill A, Lindberg LD. Short interpregnancy intervals in the United States. Obstet 
Gynecol 2013;122:64–71. 
45. World Health Orgnization: Programming Strategies for Postpartum Family Planning. 
Geneva: WHO; 2013. 
46. American Academy of Pediatrics, American College of Obstetricians and Gynecologists: 
Guidelines for Perinatal Care; 7th Edition. 2012:202–203. 
47. Cleland J, Shah IH, Daniele M. Interventions to improve postpartum family planning in low- 
and middle-income countries: program implications and research priorities. Stud Fam Plann 
2015;46:423-41.  
48. Loewenberg Weisband Y, Keder LM, Keim SA, Gallo MF. Postpartum intentions on 
contraception use and method choice among breastfeeding women attending a university 
hospital in Ohio: a cross-sectional study. Reprod Health 2017;14:45.  
49. Cwiak C, Gellasch T, Zieman M. Peripartum contraceptive attitudes and practices. 
Contraception. 2004;70:383–6. 
50. Dulli LS, Eichleay M, Rademacher K, Sortijas S, Nsengiyumva T. Meeting postpartum 
women's family planning needs through integrated family planning and immunization 
services: results of a cluster-randomized controlled trial in Rwanda. Glob Health Sci Pract 
2016;4:73-86.  
51. Lopez LM, Grey TW, Hiller JE, Chen M. Education for contraceptive use by women after 
childbirth. Cochrane Database Syst Rev 2015;(7):CD001863. 
52. Lopez LM, Grey TW, Chen M, Hiller JE. Strategies for improving postpartum contraceptive 
use: evidence from non‐randomized studies. Cochrane Database Syst 
Rev 2014;(11):CD011298. 
53. Brahmi D, Curtis KM. When can a woman start combined hormonal contraceptives 
(CHCs)? A systematic review. Contraception 2013;87:524-38.  
54. Klag EA, McNamara K, Geraghty SR, Keim SA. Associations between breast milk feeding, 
introduction of solid foods, and weight gain in the first 12 months of life. Clin Pediatr 
2015;54:1059-67.  
55. Centers for Disease Control and Prevention. Breastfeeding report card: Progressing toward 
national breastfeeding goals, United States, 2016. CDC: Atlanta, GA, 2016. 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 22 
56. Rattray C, Wiener J, Legardy-Williams J, Costenbader B, Pazol K, Medley-Singh N, et al. 
Effects of initiating a contraceptive implant on subsequent condom use: a randomized 
controlled trial. Contraception 2015;92:560-6. 
57. Feldblum PJ, Caraway J, Bahamondes L, El-Shafei M, Quan Ha D, Morales E, et al. 
Randomized assignment to copper IUD or depot-medroxyprogesterone acetate: feasibility 
of enrollment, continuation and disease ascertainment. Contraception 2005;72:187-91. 
58. Hubacher D, Raymond ER, Beksinska M, Delany-Moretlwe S, Smit J, Hylton-Kong T, et al. 
Hormonal contraception and the risks of STI acquisition: results of a feasibility study to plan 
a future randomized trial. Contraception 2008;77:366-70. 
59. Singh S, Sedgh G, Hussain R. Unintended pregnancy: worldwide levels, trends and 
outcomes. Stud Fam Plann 2010;41:241-50.  
60. Giudice LC, Sitruk-Ware R, Bremner WJ, Hillard P. Scientific vision workshop on 
reproduction, workshop white paper. Eunice Kennedy Shriver National Institute of Child 
Health and Human Development, January 25-26, Bethesda, Maryland, 2011. 
61. U.S. Department of Health and Human Services. The Surgeon General’s call to action to 
support breastfeeding. Washington, DC: U.S. DHHS, Office of the Surgeon General, 2011. 
62. Ip S, Chung M, Raman G, Chew P, Magula N, DeVine D, et al. Breastfeeding and maternal 
and infant health outcomes in developed countries: evidence report/ technology 
assessment no. 153. Rockville, MD: Agency for Healthcare Research and Quality, 2007. 
AHRQ Publication No. 07-E007.  
63. Speroff L, Mishell DR Jr. The postpartum visit: it's time for a change in order to optimally 
initiate contraception. Contraception 2008;78:90-8. 
64. Cronin TJ. Influence of lactation upon ovulation. Lancet 1968;2: 422-4. 
65. Stuart GS, Lesko CR, Stuebe AM, Bryant AG, Levi EE, Danvers AI. A randomized trial of 
levonorgestrel intrauterine system insertion 6 to 48h compared to 6 weeks after vaginal 
delivery; lessons learned. Contraception 2015;91:284-8. 
66. Ross J, Stover J. Use of modern contraception increases when more methods become 
available: analysis of evidence from 1982–2009. Glob Health Sci Pract 2013;1:203-12. 
67. United Nations Department of Economic and Social Affairs (2011) World Contraceptive Use 
2011. Available at: 
http://www.un.org/esa/population/publications/contraceptive2011/wallchart_front.pdf.  
68. World Health Organization. Trends in maternal mortality: 1990 to 2015: estimates by WHO, 
UNICEF, UNFPA, World Bank Group and the United Nations Population Division, 2015. 
69. World Health Organization. From evidence to policy: optimizing the health workforce for 
effective family planning services. WHO policy brief. WHO: Geneva, 2012.  
70. Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, 
not choice. Lancet 2002;359:515-9. 
71. Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. Vital Health 
Stat 2010;23:1-44. 
72. Fomon SJ, Haschke F, Ziegler EE, Nelson SE 1982 Body composition of reference children 
from birth to age 10 years. Am J Clin Nutr 35:1169-75. 
73. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data 
capture (REDCap)--a metadata-driven methodology and workflow process for providing 
translational research informatics support. J Biomed Inform 2009;42:377-81. 
74. Chapman DJ, Pérez-Escamilla R. Does delayed perception of the onset of lactation shorten 
breastfeeding duration? J Hum Lact 1999;15:107-11. 
75. Centers for Disease Control and Prevention. NIS Survey Methods. Available at 
http://www.cdc.gov/breastfeeding/data/nis_data/survey_methods.htm 
76. Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, et al. A 9-valent HPV 
vaccine against infection and intraepithelial neoplasia in women. N Engl J Med 
2015;372:711-23. 


Immediate postpartum DMPA; last revised on May 5, 2021  
p. 23 
77. Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD, et al. Three-
year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. 
Contraception 2015;92:10-6.  
78. Sievers E, Haase S, Oldigs HD, Schaub J. The impact of peripartum factors on the onset 
and duration of lactation. Biol Neonate 2003;83:246-52. 
79. Abrams BF, Laros RK Jr. Prepregnancy weight, weight gain, and birth weight. Am J Obstet 
Gynecol 1986;154:503-09. 
80. Hull HR, Dinger MK, Knehans AW, Thompson DM, Fields DA. Impact of maternal body 
mass index on neonate birthweight and body composition. Am J Obstet Gynecol 
2008;198:416.e1-416.e6 
81. White K, Teal SB, Potter JE. Contraception after delivery and short interpregnancy intervals 
among women in the United States. Obstet Gynecol 2015;125:1471-7. 
82. Morrison CS, Chen PL, Kwok C, Baeten JM, Brown J, Crook AM, et al. Hormonal 
contraception and the risk of HIV acquisition: an individual participant data meta-analysis. 
PLoS Med 2015;12:e1001778.  
83. Polis CB, Phillips SJ, Curtis KM, Westreich DJ, Steyn PS, Raymond E, et al. Hormonal 
contraceptive methods and risk of HIV acquisition in women: a systematic review of 
epidemiological evidence. Contraception 2014;90:360-90.  
84. Cates W; Evidence for Contraceptive Options and HIV Outcomes (ECHO) Consortium. 
Research on hormonal contraception and HIV. Lancet 2014;383:303-4.  
85. United Nations Population Division. Annual number of births – World. Geneva: UNPD, 
2011. 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 1 of 9 
Form date: 07/18/16  
 
 
1 
The Ohio State University Combined Consent to Participate in 
2 
Research and HIPAA Research Authorization 
3 
 
4 
 
5 
Study Title: 
Postpartum Family Planning 
Principal Investigator: 
Maria F. Gallo, PhD 
Sponsor:  
National Institutes of Health 
 
6 
• This is a consent form for research participation.  It contains important information 
7 
about this study and what to expect if you decide to participate.  Please consider the 
8 
information carefully. Feel free to discuss the study with your friends and family and 
9 
to ask questions before making your decision whether or not to participate. 
10 
• Your and your child’s participation is voluntary.  You may refuse to participate in 
11 
this study.  If you decide to take part in the study, you and your child may leave the 
12 
study at any time.  No matter what decision you make, there will be no penalty to you 
13 
and your child and you will not lose any of your usual benefits.  Your decision will not 
14 
affect your future relationship with The Ohio State University.  If you are a student or 
15 
employee at Ohio State, your decision will not affect your grades or employment 
16 
status. 
17 
• You and your child may or may not benefit as a result of participating in this 
18 
study.  Also, as explained below, your participation may result in unintended or 
19 
harmful effects for you that may be minor or may be serious depending on the nature 
20 
of the research. 
21 
• You will be provided with any new information that develops during the study 
22 
that may affect your decision whether or not to continue to participate.  If you 
23 
decide to participate, you will be asked to sign this form and will receive a copy of the 
24 
form.  You and your child are being asked to consider participating in this study for 
25 
the reasons explained below.   
26 
 
27 
1.   Why is this study being done? 
28 
 
29 
Using a method of family planning after having a baby helps prevent closely spaced 
30 
births. Having a repeat birth too soon can be bad for the mother and infant’s health.   
31 
 
32 
Depo-Provera is an shot that contains the hormone progestin. The shot is good for 
33 
preventing pregnancy for 12 weeks.  Women can receive the shot right after giving birth.   
34 
 
35 
We are doing this study to better understand the effects of immediate use of Depo-Provera 
36 
on breastfeeding and long-term use of family planning. 
37 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
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IRB Approval date:   
Version:   
 
 
Page 2 of 9 
Form date: 07/18/16  
 
 
38 
2.   How many people will take part in this study? 
39 
 
40 
About 800 adult women and their infant will take part in the study. 
41 
 
42 
3.   What will happen if I take part in this study? 
43 
 
44 
We will randomly put women after they give birth into one of three groups: 1) one group 
45 
will receive the Depo-Provera shot; 2) one group will receive a placebo shot; and 3) one 
46 
group won’t receive any shot.  If you are in the Depo-Provera or placebo shot group, you 
47 
will receive your shot after delivery and before hospital discharge.  If you are in the Depo-
48 
Provera or placebo shot group, you should not use any hormonal contraceptive method for 
49 
the next 6 weeks and you should not use Depo-Provera for the next 12 weeks. The placebo 
50 
shot is made to look the same as the Depo-Provera shot but does not have any active 
51 
ingredients.  The shots are blinded.  That means that you won’t know whether you receive 
52 
Depo-Provera or the placebo shot.   
53 
 
54 
Women will be put into the groups by chance, which works like flipping a coin.  You and 
55 
study staff will not be able to choose which group you join.  All three groups are very 
56 
important.   
57 
 
58 
We will ask you questions while you are in the hospital about your health, family 
59 
planning, and breastfeeding. These questions will take about 20 minutes to answer.  We 
60 
also will ask you repeatedly about your milk let-down while you are in the hospital.  
61 
During the first days that you return home, we also may ask you these questions again by 
62 
phone, text or email depending on your choice.  These questions will take about 5 minutes 
63 
to answer. 
64 
 
65 
We will use information from your medical records at OSUWMC and the place where 
66 
you went to for prenatal care.   
67 
 
68 
We will talk to you about condom use and give you some condoms. 
69 
 
70 
We will ask you to complete a questionnaire either online or by telephone at 1, 2, 4, 6, 9 
71 
and 12 months after you give birth.  This questionnaire will take about 30 minutes to 
72 
answer. 
73 
 
74 
We will ask you to return to OSUWMC after four months with your infant so that we can 
75 
weigh and measure your infant.  This visit will take about 30 minutes to complete.  We 
76 
also will use information from your infant’s medical records at his or her well-child care 
77 
visits during the first 12 months.   
78 
 
79 
We may contact you to remind you of the questionnaires or the visit in four months.   
80 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 3 of 9 
Form date: 07/18/16  
 
If you want to avoid pregnancy during the first year after you give birth, you should get 
81 
another Depo-Provera shot every 12 weeks or else use another method of family planning.  
82 
The study will not cover these costs.  
83 
 
84 
4.   How long will I be in the study? 
85 
 
86 
Study participation is for the first 12 months after delivery. 
87 
 
88 
5. Can I stop being in the study? 
89 
 
90 
You and your child may leave the study at any time.  If you decide to stop participating in 
91 
the study, there will be no penalty to you, and you and your child will not lose any 
92 
benefits to which you are otherwise entitled.  Your decision will not affect your future 
93 
relationship with The Ohio State University.  
94 
 
95 
6.   What risks, side effects or discomforts can I expect from being in the study? 
96 
 
97 
You might feel embarrassed or anxious when you are answering questions.  You may 
98 
choose not to answer any question for any reason.   
99 
 
100 
You may feel slight discomfort from the shot. You may have changes in your menses, 
101 
such as irregular bleeding, spotting, or no periods. 
102 
 
103 
Studies have found that women lose bone mass density during Depo-Provera use but 
104 
recover this after they stop using it. 
105 
 
106 
Detectable amounts of drug have been found in the milk of mothers using Depo-Provera.  
107 
In theory, Depo-Provera could potentially interfere with milk composition, quality, and 
108 
amount, but no studies have shown that so far. Young infants exposed to 
109 
medroxyprogesterone (active ingredient in Depo-Provera) from breast milk have been 
110 
studied for effects on their development and behavior through puberty. No adverse effects 
111 
have been noted. 
112 
 
113 
7.   What benefits can I expect from being in the study? 
114 
 
115 
There are no direct benefits from being in the study. The research could benefit women in 
116 
general by helping us better understand how to help prevent unintended pregnancy. 
117 
 
118 
8.   What other choices do I have if I do not take part in the study? 
119 
 
120 
You may choose not to participate without penalty or loss of benefits to which you and 
121 
your child are otherwise entitled. 
122 
 
123 
9. What are the costs of taking part in this study? 
124 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
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IRB Approval date:   
Version:   
 
 
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125 
There is no cost to you or your child for being in this study. 
126 
 
127 
10. Will I be paid for taking part in this study? 
128 
 
129 
To pay you for your time, you will receive $80 in cash before leaving the hospital for 
130 
completing the questionnaire after giving birth.   
131 
 
132 
We will ask you to complete a short questionnaire on milk let-down several times before 
133 
hospital discharge and then daily at home by telephone, email or text for up to the first 
134 
seven days postpartum. You will receive a $30 electronic gift card to Walmart or Target 
135 
once for completing this short questionnaire multiple times.   
136 
 
137 
You will receive a $10 electronic gift card to Walmart or Target for completing each of 
138 
the six on-line questionnaires during the first year after giving birth (for a total of up to 
139 
$60).  
140 
 
141 
At the visit in four months, you will receive a $40 gift card to Kroger’s for returning with 
142 
your infant.  We also will either give you a parking pass at this time for this visit or 
143 
provide you with transportation to the visit, depending on which you prefer.     
144 
 
145 
By law, payments to subjects are considered taxable income.  
146 
 
147 
11. What happens if I or my child am injured because we took part in this study? 
148 
 
149 
If you or your child suffer an injury from participating in this study, you should notify the 
150 
study doctor immediately. This person will determine if you or your child should obtain 
151 
medical treatment at OSUWMC.   
152 
 
153 
The cost for this treatment will be billed to you or your medical or hospital insurance. The 
154 
Ohio State University has no funds set aside for the payment of health care expenses for 
155 
this study.  
156 
 
157 
12. What are my rights if I take part in this study? 
158 
 
159 
If you choose to participate in the study, you and your child may discontinue participation 
160 
at any time without penalty or loss of benefits.  By signing this form, you do not give up 
161 
any personal legal rights you and your child may have as participants in this study. 
162 
 
163 
You will be provided with any new information that develops during the course of the 
164 
research that may affect your decision whether or not to continue participation in the 
165 
study. 
166 
 
167 
You may refuse to participate in this study without penalty or loss of benefits to which 
168 
you and your child are otherwise entitled. 
169 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 5 of 9 
Form date: 07/18/16  
 
 
170 
An Institutional Review Board responsible for human subjects research at The Ohio State 
171 
University reviewed this research project and found it to be acceptable, according to 
172 
applicable state and federal regulations and University policies designed to protect the 
173 
rights and welfare of participants in research. 
174 
 
175 
13. Will my and my child’s study-related information be kept confidential? 
176 
 
177 
Efforts will be made to keep you and your child’s study-related information confidential.  
178 
However, there may be circumstances where this information must be released.  For 
179 
example, personal information regarding your participation in this study may be disclosed 
180 
if required by state law.   
181 
 
182 
Also, your and your child’s records may be reviewed by the following groups (as 
183 
applicable to the research): 
184 
• 
Office for Human Research Protections or other federal, state, or international 
185 
regulatory agencies; 
186 
• 
U.S. Food and Drug Administration; 
187 
• 
The Ohio State University Institutional Review Board or Office of Responsible 
188 
Research Practices; and 
189 
• 
NIH, their agents or study monitors. 
190 
 
191 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
192 
required by U.S. law.  This website will not include information that can identify you.  At 
193 
most, the website will include a summary of the results.  You can search the website at 
194 
any time.  
195 
 
196 
We will work to make sure that no one sees your survey responses without approval. But, 
197 
because we are using the Internet, there is a chance that someone could access your online 
198 
responses without permission. In some cases, this information could be used to identify 
199 
you. 
200 
 
201 
To help us protect your privacy, the National Institutes of Health has issued a Certificate 
202 
of Confidentiality for this study. This Certificate will be used to resist attempts to force us 
203 
to disclose information that may identify you, even by a court subpoena, in any federal, 
204 
state, or local civil, criminal, administrative, legislative, or other proceedings. 
205 
 
206 
The Certificate cannot be used to resist a demand for information that is used for auditing 
207 
or evaluation of federally funded projects or for information that must be disclosed to 
208 
meet the requirements of the Food and Drug Administration (FDA). 
209 
 
210 
A Certificate of Confidentiality does not prevent you or a member of your family from 
211 
voluntarily releasing information about yourself or your participation in this research. If 
212 
an insurer, employer, or other person obtains your written consent to receive research 
213 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 6 of 9 
Form date: 07/18/16  
 
information, then we will release the information even though we have the Certificate of 
214 
Confidentiality. 
215 
 
216 
The Certificate of Confidentiality also does not prevent us from disclosing voluntarily, 
217 
without your consent, information that would identify you as a participant in the research 
218 
if required by state and/or federal law.  In Ohio, if we have reasonable knowledge that a 
219 
felony has been or is being committed we are required to notify state officials. 
220 
 
221 
14. HIPAA AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR 
222 
      RESEARCH PURPOSES  
223 
 
224 
I. What information may be used and given to others? 
225 
 
226 
• Past and past medical records at OSUWMC for you and your child; 
227 
• Medical records for your infant’s pediatric visits; 
228 
• Research records; 
229 
• Information that includes personal identifiers, such as you and your child’s names, 
230 
or a number associated with you as an individual; 
231 
• Information gathered for this research about physical exams and questionnaires; 
232 
and 
233 
• Records about any study drug you received. 
234 
 
235 
II. Who may use and give out information about you? 
236 
 
237 
Researchers and study staff.   
238 
 
239 
III. Who might get this information? 
240 
 
241 
• The sponsor of this research: the National Institutes of Health (NIH).  “Sponsor” 
242 
means any persons or companies that are: 
243 
• working for or with the sponsor; or  
244 
• owned by the sponsor. 
245 
• Authorized Ohio State University staff not involved in the study may be aware that 
246 
you are participating in a research study and have access to your information; 
247 
• If this study is related to your medical care, your study-related information may be 
248 
placed in your permanent hospital, clinic or physician’s office record; 
249 
 
250 
IV. Your information may be given to: 
251 
  
252 
• The U.S. Food and Drug Administration (FDA), Department of Health and Human 
253 
Services (DHHS) agencies, and other federal and state entities; and  
254 
• The Ohio State University units involved in managing and approving the research 
255 
study including the Office of Research and the Office of Responsible Research 
256 
Practices. 
257 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 7 of 9 
Form date: 07/18/16  
 
 
258 
V. Why will this information be used and/or given to others? 
259 
 
260 
• To do the research;  
261 
• To study the results; and  
262 
• To make sure that the research was done right.   
263 
 
264 
VI. When will my permission end? 
265 
 
266 
There is no date at which your permission ends. You and your child’s information will be 
267 
used indefinitely. This is because the information used and created during the study may 
268 
be analyzed for many years, and it is not possible to know when this will be complete. 
269 
 
270 
VII. May I withdraw or revoke (cancel) my permission? 
271 
 
272 
Yes. Your permission will be good for the time period indicated above unless you change 
273 
your mind and revoke it in writing. You may withdraw or take away your permission to 
274 
use and disclose you and your child’s health information at any time. You do this by 
275 
sending written notice to the researchers. If you withdraw your permission, you and your 
276 
child will not be able to stay in this study. When you withdraw your permission, no new 
277 
health information identifying you or your child will be gathered after that date. 
278 
Information that has already been gathered may still be used and given to others. 
279 
 
280 
VIII. What if I decide not to give permission to use and give out my health 
281 
information? 
282 
 
283 
Then you and your child will not be able to be in this research study and receive research-
284 
related treatment.  However, if you are being treated as a patient here, you will still be 
285 
able to receive care. 
286 
 
287 
IX. Is my health information protected after it has been given to others? 
288 
 
289 
There is a risk that your information will be given to others without your permission. Any 
290 
information that is shared may no longer be protected by federal privacy rules. 
291 
 
292 
X. May I review or copy my information? 
293 
 
294 
Signing this authorization also means that you may not be able to see or copy your study-
295 
related information until the study is completed.   
296 
 
297 
15. Who can answer my questions about the study? 
298 
 
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CONSENT & 
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IRB Protocol Number: 
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IRB Approval date:   
Version:   
 
 
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For questions, concerns, or complaints about the study, or if you feel you have been 
300 
harmed as a result of study participation, you may contact Dr. Maria Gallo at 614-688-
301 
2145 or gallo.86@osu.edu. 
302 
 
303 
For questions related to your privacy rights under HIPAA or related to this research 
304 
authorization, please contact the HIPAA Privacy Officer, Suite E2140, 600 Ackerman 
305 
Road, Columbus, OH  43201. 
306 
  
307 
For questions about your rights as a participant in this study or to discuss other study-
308 
related concerns or complaints with someone who is not part of the research team, you 
309 
may contact Ms. Sandra Meadows in the Office of Responsible Research Practices at 
310 
1-800-678-6251. 
311 
 
312 
If you are injured as a result of participating in this study or for questions about a study-
313 
related injury, you may contact Dr. Lisa Keder at keder.1@osu.edu or 614-293-4929.  
314 
315 


CONSENT & 
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IRB Protocol Number: 
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IRB Approval date:   
Version:   
 
 
Page 9 of 9 
Form date: 07/18/16  
 
Signing the consent form 
316 
 
317 
I have read (or someone has read to me) this form and I am aware that I and my child are 
318 
being asked to participate in a research study.  I have had the opportunity to ask questions and 
319 
have had them answered to my satisfaction.  I voluntarily agree to participate in this study and 
320 
I voluntarily agree for my child to participate in this study.  
321 
 
322 
I am not giving up any legal rights by signing this form.  I will be given a copy of this 
323 
combined consent and HIPAA research authorization form. 
324 
 
325 
 
 
 
 
Printed name of adult subject 
 
Signature of subject 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of child subject 
 
Signature of person authorized to consent for subject  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the subject 
 
Date and time 
 
 
326 
 
327 
Investigator/Research Staff 
328 
 
329 
I have explained the research to the participant or his/her representative before requesting the 
330 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given 
331 
to the participant or his/her representative. 
332 
 
333 
 
 
 
 
Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
334 
Witness(es) - May be left blank if not required by the IRB 
335 
 
336 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
337 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 1 of 10 
Form date: 07/18/16  
 
 
1 
Emory University and Grady Health System  
2 
Consent to be a Research Subject / HIPAA Authorization  
3 
 
4 
Study Title: 
Postpartum Family Planning 
Principal Investigators: 
Maria F. Gallo, PhD (Ohio State University), Megan Lawley, 
MD, MPH (Emory University) 
Sponsor:  
National Institutes of Health 
 
5 
• This is a consent form for research participation.  It contains important information 
6 
about this study and what to expect if you decide to participate.  Please consider the 
7 
information carefully. Feel free to discuss the study with your friends and family and 
8 
to ask questions before making your decision whether or not to participate. 
9 
• Your and your child’s participation is voluntary.  You may refuse to participate in 
10 
this study.  If you decide to take part in the study, you and your child may leave the 
11 
study at any time.  No matter what decision you make, there will be no penalty to you 
12 
and your child and you will not lose any of your usual benefits.  Your decision will not 
13 
affect your future relationship with Emory or Grady Health System.  If you are a 
14 
student or employee at Emory or Grady, your decision will not affect your grades or 
15 
employment status. 
16 
• You and your child may or may not benefit as a result of participating in this 
17 
study.  Also, as explained below, your participation may result in unintended or 
18 
harmful effects for you that may be minor or may be serious depending on the nature 
19 
of the research. 
20 
• You will be provided with any new information that develops during the study 
21 
that may affect your decision whether or not to continue to participate.  If you 
22 
decide to participate, you will be asked to sign this form and will receive a copy of the 
23 
form.  You and your child are being asked to consider participating in this study for 
24 
the reasons explained below.   
25 
 
26 
1.   Why is this study being done? 
27 
 
28 
Using a method of family planning after having a baby helps prevent closely spaced 
29 
births. Having a repeat birth too soon can be bad for the mother and infant’s health.   
30 
 
31 
Depo-Provera is a shot that contains the hormone progestin. The shot is good for 
32 
preventing pregnancy for 12 weeks.  Women can receive the shot right after giving birth.   
33 
 
34 
We are doing this study to better understand the effects of immediate use of Depo-Provera 
35 
on breastfeeding and long-term use of family planning. 
36 
 
37 


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Version:   
 
 
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2.   How many people will take part in this study? 
38 
 
39 
About 800 adult women and their infant will take part in the study. 
40 
 
41 
3.   What will happen if I take part in this study? 
42 
 
43 
We will randomly put women after they give birth into one of three groups: 1) one group 
44 
will receive the Depo-Provera shot; 2) one group will receive a placebo shot; and 3) one 
45 
group won’t receive any shot.  If you are in the Depo-Provera or placebo shot group, you 
46 
will receive your shot after delivery and before hospital discharge.  If you are in the Depo-
47 
Provera or placebo shot group, you should not use any hormonal contraceptive method for 
48 
the next 6 weeks and you should not use Depo-Provera for the next 12 weeks.. The 
49 
placebo shot is made to look the same as the Depo-Provera shot but does not have any 
50 
active ingredients.  The shots are blinded.  That means that you won’t know whether you 
51 
receive Depo-Provera or the placebo shot.   
52 
 
53 
Women will be put into the groups by chance, which works like flipping a coin.  You and 
54 
study staff will not be able to choose which group you join.  All three groups are very 
55 
important.   
56 
 
57 
We will ask you questions while you are in the hospital about your health, family 
58 
planning, and breastfeeding. These questions will take about 20 minutes to answer.  We 
59 
also will ask you repeatedly about your milk let-down while you are in the hospital.  
60 
During the first days that you return home, we also may ask you these questions again by 
61 
phone, text or email depending on your choice.  These questions will take about 5 minutes 
62 
to answer. 
63 
 
64 
We will use information from your medical records at Grady, Emory Healthcare and the 
65 
place where you went to for prenatal care.   
66 
 
67 
We will talk to you about condom use and give you some condoms. 
68 
 
69 
We will ask you to complete a questionnaire either online or by telephone at 1, 2, 4, 6, 9 
70 
and 12 months after you give birth.  This questionnaire will take about 30 minutes to 
71 
answer. 
72 
 
73 
We may contact you to remind you of the questionnaires. If you want to avoid pregnancy 
74 
during the first year after you give birth, you should get another Depo-Provera shot every 
75 
12 weeks or else use another method of family planning.  The study will not cover these 
76 
costs.  
77 
 
78 
4.   How long will I be in the study? 
79 
 
80 
Study participation is for the first 12 months after delivery. 
81 
 
82 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
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IRB Approval date:   
Version:   
 
 
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5. Can I stop being in the study? 
83 
 
84 
You and your child may leave the study at any time.  If you decide to stop participating in 
85 
the study, there will be no penalty to you, and you and your child will not lose any 
86 
benefits to which you are otherwise entitled.  Your decision will not affect your future 
87 
relationship with Grady or Emory.  
88 
 
89 
6.   What risks, side effects or discomforts can I expect from being in the study? 
90 
 
91 
You might feel embarrassed or anxious when you are answering questions.  You may 
92 
choose not to answer any question for any reason.   
93 
 
94 
You may feel slight discomfort from the shot. You may have changes in your menses, 
95 
such as irregular bleeding, spotting, or no periods. 
96 
 
97 
Studies have found that women lose bone mass density during Depo-Provera use but 
98 
recover this after they stop using it. 
99 
 
100 
Detectable amounts of drug have been found in the milk of mothers using Depo-Provera.  
101 
In theory, Depo-Provera could potentially interfere with milk composition, quality, and 
102 
amount, but no studies have shown that so far. Young infants exposed to 
103 
medroxyprogesterone (active ingredient in Depo-Provera) from breast milk have been 
104 
studied for effects on their development and behavior through puberty. No adverse effects 
105 
have been noted. 
106 
 
107 
7.   What benefits can I expect from being in the study? 
108 
 
109 
There are no direct benefits from being in the study. The research could benefit women in 
110 
general by helping us better understand how to help prevent unintended pregnancy. 
111 
 
112 
8.   What other choices do I have if I do not take part in the study? 
113 
 
114 
You may choose not to participate without penalty or loss of benefits to which you and 
115 
your child are otherwise entitled. 
116 
 
117 
9. What are the costs of taking part in this study? 
118 
 
119 
There will be no costs to you for participating in this study, other than basic expenses like 
120 
transportation. You will not be charged for any of the research activities. If the study 
121 
procedures result in any medical complications that would not fall under “injury” as 
122 
discussed above, the cost of treatment for those complications may be charged to you or 
123 
your insurance.   
124 
 
125 
10. Will I be paid for taking part in this study? 
126 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 4 of 10 
Form date: 07/18/16  
 
 
127 
To pay you for your time, you will receive $80 in electronic gift cards before leaving the 
128 
hospital for completing the questionnaire after giving birth.   
129 
 
130 
We will ask you to complete a short questionnaire on milk let-down several times before 
131 
hospital discharge and then daily at home by telephone, email or text for up to the first 
132 
seven days postpartum. You will receive a $30 electronic gift card to Walmart or Target 
133 
once for completing this short questionnaire multiple times.   
134 
 
135 
You will receive a $10 electronic gift card to Walmart or Target for completing each of 
136 
the six on-line questionnaires during the first year after giving birth (for a total of up to 
137 
$60).  
138 
 
139 
By law, payments to subjects are considered taxable income.  
140 
 
141 
11. What happens if I or my child am injured because we took part in this study? 
142 
 
143 
If you believe you have become ill or injured from this research, you should contact Dr. 
144 
Lawley at telephone number 404-686-1000. You should also let any health care provider 
145 
who treats you know that you are in a research study.   
146 
 
147 
If you get ill or injured from being in the study, Emory and Grady Health System will help 
148 
you to get medical treatment. Neither Emory, Grady Health System nor the sponsor will 
149 
pay for your medical treatment.  Your insurer will be billed for your treatment costs.  If 
150 
you do not have insurance, or if your insurance does not pay, then you will have to pay 
151 
these costs.    
152 
 
153 
Emory, Grady Health System and the sponsor have not, however, set aside any money to 
154 
pay you if you are injured as a result of being in this study or to pay for this medical 
155 
treatment. For Emory and Grady Health System, the only exception is if it is proven that 
156 
your injury or illness is directly caused by the negligence of an Emory and Grady Health 
157 
System employee. “Negligence” is the failure to follow a standard duty of care. You do 
158 
not give up any legal rights you may have by being in this study, including any right to 
159 
bring a claim for negligence.  
160 
 
161 
12. What are my rights if I take part in this study? 
162 
 
163 
If you choose to participate in the study, you and your child may discontinue participation 
164 
at any time without penalty or loss of benefits.  By signing this form, you do not give up 
165 
any personal legal rights you and your child may have as participants in this study. 
166 
 
167 
You will be provided with any new information that develops during the course of the 
168 
research that may affect your decision whether or not to continue participation in the 
169 
study. 
170 
 
171 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 5 of 10 
Form date: 07/18/16  
 
You may refuse to participate in this study without penalty or loss of benefits to which 
172 
you and your child are otherwise entitled. 
173 
 
174 
An Institutional Review Board responsible for human subjects research at The Ohio State 
175 
University reviewed this research project and found it to be acceptable, according to 
176 
applicable state and federal regulations and University policies designed to protect the 
177 
rights and welfare of participants in research. 
178 
 
179 
13. Will my and my child’s study-related information be kept confidential? 
180 
 
181 
Efforts will be made to keep you and your child’s study-related information confidential.  
182 
However, there may be circumstances where this information must be released.  For 
183 
example, personal information regarding your participation in this study may be disclosed 
184 
if required by state law.   
185 
 
186 
Also, your and your child’s records may be reviewed by the following groups (as 
187 
applicable to the research): 
188 
• 
Office for Human Research Protections or other federal, state, or international 
189 
regulatory agencies; 
190 
• 
U.S. Food and Drug Administration; 
191 
• 
The Ohio State University Institutional Review Board or Office of Responsible 
192 
Research Practices; 
193 
• 
Emory and Grady Health System offices that are part of the Human Research 
194 
Participant Protection Program and those that are involved in study administration 
195 
and billing.  These include the Emory IRB, the Grady Research Oversight 
196 
Committee, the Emory Research and Healthcare Compliance Offices, and the 
197 
Emory Office for Clinical Research; and 
198 
• 
NIH, their agents or study monitors. 
199 
 
200 
Emory and Grady Health System may use and disclose your PHI to get payment for study 
201 
related treatment and to run normal business operations. 
202 
 
203 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
204 
required by U.S. law.  This website will not include information that can identify you.  At 
205 
most, the website will include a summary of the results.  You can search the website at 
206 
any time.  
207 
 
208 
We will work to make sure that no one sees your survey responses without approval. But, 
209 
because we are using the Internet, there is a chance that someone could access your online 
210 
responses without permission. In some cases, this information could be used to identify 
211 
you. 
212 
 
213 
There is a Certificate of Confidentiality from the National Institutes of Health for this Study.  The 
214 
Certificate of Confidentiality helps us to keep others from learning that you participated in this study.  
215 
Emory will rely on the Certificate of Confidentiality to refuse to give out study information that 
216 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 6 of 10 
Form date: 07/18/16  
 
identifies you.  For example, if Emory received a subpoena for study records, it would not give out 
217 
information that identifies you. 
218 
 
219 
The Certificate of Confidentiality does not stop you or someone else, like a member of your family, 
220 
from giving out information about your participation in this study.  For example, if you let your 
221 
insurance company know that you are in this study, and you agree to give the insurance company 
222 
research information, then the investigator cannot use the Certificate to withhold this information. This 
223 
means you and your family also need to protect your own privacy. 
224 
 
225 
The Certificate does not stop Emory from making the following disclosures about you: 
226 
 
227 
• 
Giving state public health officials information about certain infectious diseases, 
228 
• 
Giving law officials information about abuse of a child, elderly person or disabled person. 
229 
• 
Giving out information to prevent harm to you or others. 
230 
 
231 
Giving the study sponsor or funders information about the study, including information for an audit or 
232 
evaluation. 
233 
 
234 
14. MEDICAL RECORD 
235 
 
236 
You already have a Grady Health System or Emory Healthcare medical record. Copies of the consent 
237 
form/HIPAA authorization that you sign will be put in any Emory and Grady Health System medical 
238 
record you have now or any time during the study.   
239 
 
240 
Emory and Grady Health System may create study information about you that can help with your care.  
241 
For example, a note may be added to your medical record to let your doctors know that you are 
242 
participating in a family planning study.  These study results will be put in your Emory and Grady 
243 
Health System medical record. Anyone who has access to your medical records will be able to have 
244 
access to all the study information placed there.  The confidentiality of the study information in your 
245 
medical record will be protected by laws like the HIPAA privacy rule.  State and federal laws may not 
246 
protect the research information from disclosure.  
247 
 
248 
Tests and procedures done at non-Emory and Grady Health System places may not become part of 
249 
your Emory and Grady Health System medical record. Also, if you decide to be in this study, it is up 
250 
to you to let your other health providers know.  
251 
 
252 
14. HIPAA AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR 
253 
      RESEARCH PURPOSES  
254 
 
255 
I. What information may be used and given to others? 
256 
 
257 
• Past and past medical records at Grady Health System and Emory Healthcare for 
258 
you and your child; 
259 
• Medical records for your infant’s pediatric visits; 
260 
• Research records; 
261 
• Information that includes personal identifiers, such as you and your child’s names, 
262 
or a number associated with you as an individual; 
263 


CONSENT & 
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IRB Protocol Number: 
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IRB Approval date:   
Version:   
 
 
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• Information gathered for this research about physical exams and questionnaires; 
264 
and 
265 
• Records about any study drug you received. 
266 
 
267 
II. Who may use and give out information about you? 
268 
 
269 
Researchers and study staff.   
270 
 
271 
III. Who might get this information? 
272 
 
273 
• The sponsor of this research: the National Institutes of Health (NIH).  “Sponsor” 
274 
means any persons or companies that are: 
275 
• working for or with the sponsor; or  
276 
• owned by the sponsor. 
277 
• Authorized Ohio State University, Emory University, or Grady Health System 
278 
staff not involved in the study may be aware that you are participating in a 
279 
research study and have access to your information; 
280 
• If this study is related to your medical care, your study-related information may be 
281 
placed in your permanent hospital, clinic or physician’s office record; 
282 
 
283 
IV. Your information may be given to: 
284 
  
285 
• The U.S. Food and Drug Administration (FDA), Department of Health and Human 
286 
Services (DHHS) agencies, and other federal and state entities; and  
287 
• The Ohio State University, Emory University, or Grady Health System units 
288 
involved in managing and approving the research study including the Office of 
289 
Research and the Office of Responsible Research Practices. 
290 
 
291 
V. Why will this information be used and/or given to others? 
292 
 
293 
• To do the research;  
294 
• To study the results; and  
295 
• To make sure that the research was done right.   
296 
 
297 
VI. When will my permission end? 
298 
 
299 
There is no date at which your permission ends. You and your child’s information will be 
300 
used indefinitely. This is because the information used and created during the study may 
301 
be analyzed for many years, and it is not possible to know when this will be complete. 
302 
 
303 
VII. May I withdraw or revoke (cancel) my permission? 
304 
 
305 
Yes. Your permission will be good for the time period indicated above unless you change 
306 
your mind and revoke it in writing. You may withdraw or take away your permission to 
307 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 8 of 10 
Form date: 07/18/16  
 
use and disclose you and your child’s health information at any time. You do this by 
308 
sending written notice to the researchers. If you withdraw your permission, you and your 
309 
child will not be able to stay in this study. When you withdraw your permission, no new 
310 
health information identifying you or your child will be gathered after that date. 
311 
Information that has already been gathered may still be used and given to others. 
312 
 
313 
VIII. What if I decide not to give permission to use and give out my health 
314 
information? 
315 
 
316 
Then you and your child will not be able to be in this research study and receive research-
317 
related treatment.  However, if you are being treated as a patient here, you will still be 
318 
able to receive care. 
319 
 
320 
IX. Is my health information protected after it has been given to others? 
321 
 
322 
There is a risk that your information will be given to others without your permission. Any 
323 
information that is shared may no longer be protected by federal privacy rules. 
324 
 
325 
X. May I review or copy my information? 
326 
 
327 
Signing this authorization also means that you may not be able to see or copy your study-
328 
related information until the study is completed.   
329 
 
330 
15. Who can answer my questions about the study? 
331 
 
332 
For questions related to your privacy rights under HIPAA or related to this research 
333 
authorization, please contact the HIPAA Privacy Officer, Suite E2140, 600 Ackerman 
334 
Road, Columbus, OH  43201. 
335 
  
336 
You may contact the Emory University Institutional Review Board at 404-712-0720 or 877-
337 
503-9797 or irb@emory.edu: 
338 
• if you have questions about your rights as a research participant. 
339 
• if you have questions, concerns or complaints about the research. 
340 
• You may also let the IRB know about your experience as a research participant through 
341 
our Research Participant Survey at http://www.surveymonkey.com/s/6ZDMW75. 
342 
 
343 
You may contact Dr. Megan Lawley at 404-778-1384 or Sarah CordesJamila Jeff at 404-
344 
778-1358828-0663: 
345 
• if you have any questions about this study or your part in it,   
346 
• if you feel you have had a research-related injury or a bad reaction to the study drug, 
347 
or 
348 
• if you have questions, concerns or complaints about the research 
349 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 9 of 10 
Form date: 07/18/16  
 
 
350 
If you are a patient receiving care from the Grady Health System and have a question about your 
351 
rights, you may contact the Office of Research Administration at research@gmh.edu. 
352 
353 


CONSENT & 
AUTHORIZATION 
 
 
 
IRB Protocol Number: 
2017H0445 
IRB Approval date:   
Version:   
 
 
Page 10 of 10 
Form date: 07/18/16  
 
Signing the consent form 
354 
 
355 
I have read (or someone has read to me) this form and I am aware that I and my child are 
356 
being asked to participate in a research study.  I have had the opportunity to ask questions and 
357 
have had them answered to my satisfaction.  I voluntarily agree to participate in this study and 
358 
I voluntarily agree for my child to participate in this study.  
359 
 
360 
I am not giving up any legal rights by signing this form.  I will be given a copy of this 
361 
combined consent and HIPAA research authorization form. 
362 
 
363 
 
 
 
 
Printed name of adult subject 
 
Signature of subject 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of child subject 
 
Signature of person authorized to consent for subject  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the subject 
 
Date and time 
 
 
364 
 
365 
Investigator/Research Staff 
366 
 
367 
I have explained the research to the participant or his/her representative before requesting the 
368 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given 
369 
to the participant or his/her representative. 
370 
 
371 
 
 
 
 
Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
372 
Witness(es) - May be left blank if not required by the IRB 
373 
 
374 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
375