Effect of Immediate Versus Standard Postpartum Insertion of the Contraceptive Implant on Breastfeeding Outcomes
Phase: PHASE4
Conditions: Contraception
Sponsor: University of New Mexico

PROTOCOL TITLE: Effect of immediate versus standard postpartum insertion of the 
contraceptive implant on breastfeeding outcomes
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Version Date: 5/15/2024
PROTOCOL TITLE:
Effect of immediate versus standard postpartum insertion of the contraceptive implant on 
breastfeeding outcomes
PRINCIPAL INVESTIGATOR:
Jamie Krashin, MD
OBGYN
ADMINISTRATIVE CONTACT:
Cassandra Darley
OBGYN
VERSION NUMBER:
12
DATE:
 5/15/2024
REGULATORY FRAMEWORK:
Please indicate all that apply:
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
HHS (Department of Health and Human Services)
VA
Other: 
Is this a clinical trial under ICH-GCP E6?   
 Yes   
 No
If yes, please confirm that the research team is familiar with and agrees to comply 
with the investigator requirements cited in ICH-GCP E6.  
 Yes   
 No 
ICH-GCP E6 can be accessed by copying and pasting this URL into your browser: 
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf
FUNDING:

PROTOCOL TITLE: Effect of immediate versus standard postpartum insertion of the 
contraceptive implant on breastfeeding outcomes
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Click ERA record: FP00006210, FP00008226 (Continuation)
Table of Contents
1.
Objectives.....................................................................................................................4
2.
Background ..................................................................................................................4
3.
Study Design ................................................................................................................4
4.
Inclusion and Exclusion Criteria ..................................................................................4
5.
Number of Subjects......................................................................................................4
6.
Study Timelines............................................................................................................5
7.
Study Endpoints ...........................................................................................................5
8.
Research Setting...........................................................................................................5
9.
Resources Available.....................................................................................................5
10. Prior Approvals ............................................................................................................6
11. Multi-Site Research......................................................................................................6
12. Study Procedures..........................................................................................................7
13. Data Analysis ...............................................................................................................8
14. Provisions to Monitor the Data to Ensure the Safety of Subjects ................................8
15. Withdrawal of Subjects ................................................................................................8
16. Data Management/Confidentiality ...............................................................................9
17. Data and Specimen Banking ......................................................................................10
18. Risks to Subjects ........................................................................................................11
19. Potential Benefits to Subjects.....................................................................................11
20. Recruitment Methods .................................................................................................11
21. Provisions to Protect the Privacy Interests of Subjects ..............................................12
22. Economic Burden to Subjects ....................................................................................12
23. Compensation.............................................................................................................13
24. Compensation for Research-Related Injury ...............................................................13
25. Consent Process..........................................................................................................13
26. Documentation of Consent.........................................................................................16
27. Study Test Results/Incidental Findings......................................................................16
28. Sharing Study Progress or Results with Subjects.......................................................17
29. Inclusion of Vulnerable Populations ..........................................................................18
30. Community-Based Participatory Research ................................................................19
31. Research Involving American Indian/Native Populations .........................................19
32. Transnational Research ..............................................................................................19
33. Drugs or Devices........................................................................................................20
Checklist Section ...............................................................................................................21
34. Export Control…………………………………………………………………….22

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1. Objectives
1.1. We propose a non-inferiority randomized controlled trial (RCT) with a primary 
outcome of lactation continuation through 8 weeks postpartum comparing  women 
receiving  immediate (first 24 hours postpartum) versus standard  (4-6 weeks 
postpartum) etonogestrel (ENG) implant insertion.  Secondary outcomes include:  
number of days of postpartum bleeding, time to resumption of sexual activity, 
postpartum sexual function (measured by Female Sexual Function Index (FSFI) 
score), and postpartum mood as measured by Edinburgh Postnatal Depression 
Scale (EPDS) score. We will also measure breastfeeding exclusivity, factors 
effecting 
discontinuation 
of 
breastfeeding, 
timing 
of 
breast 
feeding 
discontinuation, 
satisfaction 
with 
postpartum 
contraceptive 
counseling, 
satisfaction with the contraceptive implant and satisfaction with bleeding pattern 
in the immediate and standard groups.
1.2. The contribution of the proposed research is to determine if immediate ENG 
implant insertion (within 24 hours) is non-inferior to standard insertion (4-6 
weeks) postpartum. We hypothesize that inserting the ENG implant in the first 24 
hours postpartum is not inferior to standard insertion at 4-6 week postpartum for 
breastfeeding continuation through 8 weeks postpartum.
1.2.1. Primary Objective 1: To compare continuation of lactation through eight 
weeks postpartum between women in the immediate versus standard group. 
Our hypothesis is that breastfeeding continuation at eight weeks postpartum 
is not inferior in women in the immediate insertion group of the ENG implant 
than in those with standard insertion.  Our study is powered for this outcome.
1.3. Secondary Objectives: To compare number of days of postpartum bleeding, 
postpartum sexual function as measured by FSFI score, and postpartum mood as 
measured by EPDS score, time to resumption of sexual activity, exclusive 
breastfeeding method, factors associated with discontinuing breastfeeding, timing 
of 
breastfeeding 
discontinuation, 
patient 
satisfaction 
with 
postpartum 
contraception counseling and the implant and patient satisfaction with bleeding 
pattern between the immediate and standard insertion groups. 
1.3.1. Secondary Objective 1: To compare the total number of days of postpartum 
bleeding in the immediate versus standard group at 2, 4, and 8 weeks 
postpartum . Our hypothesis is that number of days of bleeding in the 
immediate insertion group is not significantly different than the number of 
days of bleeding in the standard insertion group.
1.3.2. Secondary Objective 2: To compare postpartum sexual function as 
measured by Female Sexual Function Index (FSFI) score at 4, 8, and 12 weeks 
postpartum. Our hypothesis is that FSFI scores for the immediate insertion 
group are not significantly different than FSFI scores for the standard insertion 
group.

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contraceptive implant on breastfeeding outcomes
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1.3.3. Secondary Objective 3: To compare postpartum mood as measured by 
EPDS score at 2, 4, and 8weeks postpartum. Our hypothesis is that EPDS 
scores for the immediate insertion group are not significantly different than 
EPDS scores for the standard insertion group.
1.3.4. Secondary Objectives 4: To compare exclusive breastfeeding through 6 
months postpartum between the immediate versus the standard group. 
1.3.5. Secondary Objective 5: To compare postpartum factors associated with 
discontinuing breastfeeding between the immediate versus the standard group. 
1.3.6. Secondary Objective 6: To compare timing of breastfeeding discontinuation 
through 6 months postpartum between the immediate versus the standard 
group. 
1.3.7. Secondary Objective 7: To compare participant satisfaction with 
postpartum contraception counseling in women enrolled in the study and in 
those women who opted not to enroll in the study. 
1.3.8. Secondary Objective 8: To compare participant satisfaction with timing of  
ENG implant insertion between the immediate versus the standard group. 
2. Background
2.1.
Regarding primary objectives: 
       Counseling and provision of postpartum contraception is an integral component of 
comprehensive reproductive healthcare.  A woman’s preference for contraception 
is paramount; early initiation of postpartum contraception may assist in optimal 
birth spacing promoting the wellbeing of mother and baby (1). Equally important 
is the provision of appropriate support for breastfeeding (1). Exclusive 
breastfeeding for six months with continuation beyond one year of age is 
recommended by the American Academy of Pediatrics (AAP)  (2), American 
Academy of Family Physicians (3), American College of Obstetricians and 
Gynecologists (ACOG) (4), and the World Health Organization (WHO) (5). In the 
United States, approximately 47% and 25% of women breastfeed exclusively at 
three and six months respectively, and 57% and 36% of women who supplement 
with formula continue breastfeeding at three and six months respectively (6).
       Current recommendations advise against use of combined hormonal 
contraceptives in the first 4-6 weeks postpartum due to the hypercoagulable state 
of pregnancy and the high risk for thrombogenic events (7). Progestin-only 
hormonal contraceptive methods are considered appropriate for initiation in the 
postpartum period including the ENG subdermal implant, the levonorgestrel 
intrauterine device (LNG IUD), and the depot medroxyprogesterone acetate 
injection (8). However, because lactogenesis is precipitated by progesterone 
withdrawal after placental expulsion, early initiation of progestin-containing 

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contraceptive implant on breastfeeding outcomes
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contraception could theoretically decrease lactogenesis and breastfeeding 
continuation (9). Due to this theoretical concern, immediate postpartum use of 
progestin contraceptives by breastfeeding women is classified as Category 2 
(benefits of use outweigh any theoretical or proven risks) the United States 
Medical Eligibility Criteria for Contraceptive Use, 2016 (US MEC) (8).  This 
classification balances the theoretical concern with a handful of reassuring studies.  
A University of New Mexico and University of Utah 2016 study found no 
differences in breastfeeding continuation and time to lactogenesis between groups 
randomized to immediate postpartum LNG IUD placement versus standard 
insertion at 4-6 weeks (10).  In 2017 a Cochrane review evaluated three studies of 
immediate postpartum insertion of the ENG implant versus standard insertion; it 
was unable to determine a statistically significant effect of insertion timing on 
breastfeeding continuation rates (11). The literature on the implant and 
breastfeeding outcomes is limited by a small sample size and variable timing of  
implant initiation within the first 3 days postpartum in “immediate” allocation 
groups (12-13).  Despite limitations, studies of progestin-only methods showed no 
differences in lactogenesis, infant growth, and lactation continuation (12-14).  
Additional studies with the implant are needed to precisely define postpartum 
initiation, better inform evidence-based contraceptives guidelines, and to assist in 
the provision of evidence-based counseling about the effects of immediate 
postpartum implant insertion.  
Regarding secondary objectives:
       When counseling women on their postpartum contraception options, it is important 
to address patient-centered outcomes that affect patient satisfaction with their 
contraceptive method and may affect continuation rates of highly effective 
contraception that they initially selected to support their reproductive goals. We 
have chosen bleeding pattern, mood and sexual function as the eight domains that 
we will assess and compare between the immediate and standard insertion groups 
as they are domains commonly perceived as affected negatively by contraceptives.  
In addition, we will measure breastfeeding discontinuation and reasons for 
discontinuation through 8 weeks postpartum.  These are important outcomes in 
alignment with recommendations from several professional organizations and the 
WHO.
2.2.
 Regarding primary objectives:
A systematic review identified 50 studies of progestin-only contraception and 
breastfeeding (13). These studies can be divided into those that focus on 
breastfeeding performance (initiation, continuation, and exclusivity) and those that 
focus on infant health and growth.  Fewer than ten studies focus on use of the 
contraceptive implant and breastfeeding performance, of which only two measure 
outcomes related to immediate insertion versus standard insertion (5,12). In 
Guttcheff et al., a RCT in healthy postpartum women was performed to evaluate 
time to lactogenesis stage II between early ENG implant insertion (1-3 days 

PROTOCOL TITLE: Effect of immediate versus standard postpartum insertion of the 
contraceptive implant on breastfeeding outcomes
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postpartum (PP)) and standard insertion (4-8 weeks PP). The authors demonstrated 
that early insertion is non-inferior to standard insertion with a mean difference of 
1.4 hours. In addition, no differences were found between the early insertion group 
and standard insertion group for incidence of lactation failure, breastfeeding, 
formula supplementation and breastfeeding continuation at 6 months.  Bryant et al., 
studied immediate (before leaving the hospital) versus standard (at 6 weeks PP) 
insertion of the ENG implant in adolescent and young women age 14-24 years old. 
Their primary outcome was contraceptive use at six months. No difference was 
found in contraceptive use between the two groups at six months. The rate of 
lactation continuation at three and six months was higher in the immediate insertion 
group. 
2.3.
 Regarding primary objectives:
            Prior studies lack specific data on timing of early postpartum implant use and the 
effect on breastfeeding. The contribution of the proposed research is to add to the 
limited literature on immediate postpartum contraception options and, specifically, 
to evaluate the impact of initiating ENG implants within the first 24 hours on 
breastfeeding continuation. The lack of precise timing for immediate postpartum 
progestin initiation was cited as an important research gap in the US MEC (8). 
Additionally, more and more state Medicaid programs are reimbursing for implant 
insertion prior to the hospital discharge (16). It is important to make sure that this 
increasing trend is supported by the best possible evidence. 
            
            Regarding secondary objectives:
1. Bleeding patterns: Irregular bleeding is the most common side effect noted by users 
of the ENG contraceptive implant. Limited evidence shows that this holds true in 
the postpartum period (17). In a retrospective cohort study of women who 
underwent immediate versus standard postpartum insertion of the implant, 
approximately one in five women requested discontinuation of use due to irregular 
bleeding, and this rate was not significantly different between the two groups (17). 
Evidence on the effect of immediate postpartum insertion of the ENG contraceptive 
implant on lochia is limited and mixed. An RCT of immediate versus standard 
postpartum insertion of the six-rod levonorgestrel implant showed significantly 
more total days of bleeding for the immediate insertion group (18), while a more 
recent Australian prospective cohort study demonstrated no lengthening of the 
duration of lochia (postpartum bleeding) with immediate insertion (19).  We will 
measure postpartum bleeding patterns using periodic review of a patient bleeding 
diary that quantifies bleeding on a daily basis as “none”, “spotting”, “bleeding” or 
“heavy bleeding”. As patient dissatisfaction with irregular bleeding likely mediates 
discontinuation for this reason, we will also measure patient satisfaction with their 
bleeding pattern postpartum. 

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2. Postpartum mood changes: It is possible that postpartum use of an ENG implant 
may affect postpartum mood.  In a retrospective study of adverse event reporting 
for ENG implant use, it was noted that postpartum depression was a commonly 
reported adverse event, and therefore may be associated with implant use in the 
postpartum period (20). In addition, in a secondary analysis study, use of the ENG 
implant in the postpartum period was associated with a higher risk of later 
antidepressant use compared to women with no hormonal contraceptive use (21). 
Women’s perception of contraceptives’ effect on their mood is a significant factor 
in contraception discontinuation (22). We hypothesize that timing of implant 
insertion will not increase postpartum depression related mood changes as 
measured by the EPDS. We will also assess patient perception of impact of ENG 
implant insertion on mood. 
3. Postpartum sexual function: Effect of postpartum ENG implant use on postpartum 
sexual function is not well studied. However, in a 2016 study of impact of LARC 
use on sexual function (not in the postpartum period), it was noted that there was 
no objective change in sexual function with initiation of copper IUD, levonorgestrel 
IUDs or ENG  implant (24). We hypothesize that this is also true in the postpartum 
period and that the effect of timing of ENG implant insertion will not affect 
postpartum sexual function as measured by the FSFI. The FSFI is a validated tool 
for assessing female sexual function that been used in the aforementioned studies, 
both in assessing LARC effects and in the postpartum period (25). Patient 
perceptions of the effect of their contraceptive on sexual experience may affect 
contraceptive continuation rates regardless of objective findings on sexual function. 
In a 2018 study of the impact of sexual function and perceived effect of 
contraceptive method on sexual experience on continuation rates of multiple 
LARCs, patients’ perception of a negative impact of the contraceptive on sex life 
was the strongest predictor of discontinuation (26). We will assess patient centered 
perception of impact of ENG implant insertion on sexual function. 
4. Postpartum exclusive breastfeeding through 6 months postpartum: Receiving only 
breast milk is known as exclusive breastfeeding (EBF). AAP and WHO promote 
EBF for the first six month of life of infants because it provides multiple health 
benefits to babies and to the mother (1,5). Nationally, 46.9 % and 24.9%of women 
exclusively breastfeed at 3 and 6 months, respectively; in New Mexico 53.0% and 
27.6% breastfeed exclusively at 3 and 6 months, respectively (6). Since this data 
does not provide information about the mothers who use contraception and how 
many of the exclusively breastfeed, we will assess this information.  

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5. Factors associated with breastfeeding discontinuation: As mentioned previously, 
EBF is recommended for 6 months postpartum by the AAP and WHO. It is 
important to identify and acknowledge these factors to work and plan for 
counseling and initiatives to improve the length of lactation period. These factors 
can vary depending of society, culture and even mother’s perception.  Li et al 
reported the most common reasons for breastfeeding discontinuation during the 
first year postpartum were mothers’ perception that their infant was not satisfied by 
breast milk alone and concerns about lactation and nutrition issue. In addition, 
mothers reported nipple biting and perceived infant loss of interest in breastfeeding 
(27). Odom et al, found in their study that factors such as difficulties with lactation, 
infant nutrition and weight, effort to pumping milk, among many others, play an 
important role in the decision making for lactation cessation (28). With this study, 
we aim to assess the reason for discontinuation in the mothers who use the implant 
as a contraceptive method. 
6. Satisfaction with postpartum contraception counseling: The American College of 
Obstetricians and Gynecologists (ACOG) stated in Committee Opinion number 
736: Optimizing Postpartum Care that as part of comprehensive postpartum care 
acknowledging women’s reproductive life plan is of vital importance for decision 
making regarding contraception (1). We aim to explore by a survey how women 
perceived the counseling: if she understood the counseling and received enough 
information and time to make a decision about contraceptive choice. This might 
help to understand women’s perception of counseling about postpartum 
contraception and may be helpful in improving current counseling.  
7. Satisfaction with timing of contraceptive implant insertion: Early initiation of a 
contraceptive method has been recommended as an alternative by ACOG (1). This 
is because it has been proven that many women miss or do not have a postpartum 
follow up visit and it is more convenient for women to initiate a method early. 
When a contraceptive method is started in the postpartum period, it contributes to 
birth spacing, and maternal and infant wellbeing. We look to understand the 
satisfaction with having an implant inserted early vs having it inserted in the 
standard time. 
3. Study Design
3.1. This RCT will be performed at the University of New Mexico Hospitalits affiliated 
clinics and the University of Utah and its affiliated clinics. The study design was chosen 
as the gold standard for determining cause and effect; it is methodologically strong and 
feasible for our research questions. RCTs minimize bias such as that related to 
treatment assignment (e.g., selection bias and confounding). 

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contraceptive implant on breastfeeding outcomes
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The two study groups will include women randomized to immediate (within 24 hours 
postpartum) versus standard (4-6 weeks postpartum) ENG implant insertion.  The 
primary study endpoint is any breastfeeding at eight weeks postpartum; we will also 
measure breastfeeding continuation at 2, 4, 8, 12 and 24 weeks postpartum.  
Participants will be pregnant women 13 years old and older, who desire the ENG 
implant as a postpartum contraceptive and are willing to be randomized to immediate 
implant insertion (within 24 hours postpartum) versus standard insertion (4-6 weeks 
postpartum). A total of 150 participants, 75 in each group, will be enrolled to ensure 
adequate power to determine the primary outcomes, after anticipated loss to follow up.
4. Inclusion and Exclusion Criteria
4.1. Potential participants may be identified in the following locations/timeframes:  1) 
antenatal clinics, 2) visits to OB-Triage 2) on admission to L&D for delivery not in 
active labor or 4) during the first postpartum hours in the Ob-Gyn ward of the UNM 
Hospital and University of Utah Hospital.

When women decide on an implant as a postpartum contraceptive in any of these 
venues, the PCP (Ob-Gyn, Family Medicine physicians/residents and midwives) 
may discuss the patient’s interest in hearing about the study and may contact the 
research coordinator by a message in the EMR or by phone or in person to let her 
know that the patient is interested in hearing about the study.

 Additionally, the research coordinator will review antenatal clinic, OB Triage and 
inpatient (L&D and postpartum) lists to assess patients’ contraceptive plan through 
review of the EMR.  

If the patient expresses interest, the research coordinator and/or a study co-
investigator will explain the study, screen the patient for eligibility and obtain 
informed consent.

Note: Hepatitis C will not be considered an exclusion criterion.  Mothers with 
Hepatitis C can breastfeed per the Centers for Disease Control and Prevention. 
However, HCV is spread by infected blood. Therefore, if the HCV-positive 
mothers’nipples and/or surrounding areola are cracked and bleeding, she 
should stop nursing temporarily. To maintain her milk supply while not 
breastfeeding, she can express and discard her breast milk until her nipples are 
healed. Once her nipples are no longer cracked or bleeding, the HCV-positive 
mother may fully resume breastfeeding. If we identify a mother with hepatitis 
C, we will assess through follow up questionnaires when they stopped 
breastfeeding, if they continued to express milk during the period of no lactation 
and when they restarted lactation.

Note: We will continue enrollment in the study for all women regardless of the 
infants’ status; we will perform a secondary sub-group analysis of 
women/infants with complications in order to improve the ability to generalize 
from the study.
We request a waiver of HIPAA for screening/recruitment purposes.

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4.2. Inclusion Criteria

Pregnant women or women who have delivered vaginally and by cesarean 
section within 22 hours (2 hour window will allow for implant insertion by 24 
hours postpartum)

Aged 13 and older

English or Spanish speakers

Deliver an infant at UNM or Utah Hospital at > 37 weeks gestational age

Intend to breastfeed

Desire the implant as a method for contraception

Agree to randomization

Must have a working phone (study questions to be answered through phone 
calls or accessed electronically by a link sent through email or text message)
Exclusion Criteria 

Under age 13

History of breast cancer (screen by past medical history)

History of undiagnosed vaginal bleeding (screen by past medical history)

Head trauma that affected pituitary function (screen by past medical history)

Prolactin insufficiency (screen by past medical history)

Previous lactation failure (defined as no lactation within 5 days postpartum)

Any contraindication to lactation/implant use including diseases transmittable 
by breast milk (screen by past medical history)

Liver dysfunction (screen by past medical history)

Use of drugs that inhibit lactation (screen by medical history)

Sensitivity to the components of the ENG implant (screen by past medical 
history)

Contraindications to use the implant by the  (US MEC) (screen by past medical 
history)

Active labor

Delivery at < 37 weeks gestational age
There is a description of different inclusion/exclusion criteria between the sites. UNM Is 
recruiting minors under age 18 and over the age of 13, and the University of Utah is not 
recruiting minors. This is the only difference in the protocols.
4.3. This study will include pregnant adolescent and adult women. This study will not 
recruit adults who are unable to consent or women who are incarcerated.
4.4. This study will recruit women who can speak and read English and/or Spanish 
fluently. 
5. Number of Subjects
5.1 NA

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5.2. This is a multi-site study. Through the University of New Mexico Hospital, its 
affiliated clinics and the University of Utah and its affiliated clinics.  We will recruit 
up to 200 participants between both study sites.
5.3. Up to 200 participants will be enrolled, with a goal of 75 in each group, to ensure 
adequate power to determine the primary outcome, after anticipated loss to follow up.
This study is a non-inferiority trial designed to demonstrate that immediate postpartum 
insertion of the ENG implant is non-inferior to standard ENG implant insertion with 
respect to the proportion of women who discontinue breastfeeding by 8 weeks after 
delivery. Discontinuation of breastfeeding under the current treatment, standard 
insertion, is expected to be 30% based on previous studies (10, 15).  To achieve 80% 
power with a 1-sided Type 1 error of 5% utilizing the Z test (unpooled), 62 participants 
are required in each group for a total of 124. Accounting for expected loss to follow up 
of 20%, the total number of participants required is 149, rounded to 150. We intend to 
enroll up to 200 participants due to unanticipated loss to follow up, so this should 
ensure that we have enough data for data analysis.
6. Study Timelines
6.1. The estimated total of duration of the study is 18 months. Participants will be 
followed for 24 weeks (please see timeline below and further specific details on data 
collection in Section 12).  Enrollment is estimated to start at the beginning of 2019.  All 
participants will be recruited within a one-year time frame. The research project will 
conclude once all enrolled participants have been followed for 6 months and completed 
the questionnaires.  Primary analyses will begin once all study participant complete the 
8 weeks follow-up to accomplish the analysis for the primary outcomes.
* primary outcomes

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7. Study Endpoints
7.1. The primary endpoint of this research are to compare continuation of lactation at 
eight week postpartum between women in the immediate with standard  group.
The secondary endpoints of this research are to compare number of days of 
postpartum bleeding, postpartum sexual function as measured by FSFI score, and 
postpartum mood as measured by EPDS score, time to resumption of sexual activity, 
exclusive 
breastfeeding 
method, 
factors 
associated 
with 
discontinuing 
breastfeeding, timing of breastfeeding discontinuation, patient satisfaction with 
postpartum contraception counseling and the implant and patient satisfaction with 
bleeding pattern between the immediate and standard insertion groups.
As in other studies of breastfeeding and hormonal contraception, we will continue 
to follow women out to 6 months. A survival analysis will be performed to determine 
longer-term effect of hormonal contraception on breastfeeding.
Screen
-ing 
First 
24 
hours 
Post
partu
m
1-7 
days*
2 
weeks 
4 
weeks 
6 
weeks 
8 
weeks
12 
weeks  
24 
weeks 
END
Up to 
1 year 
pp
Up to 5 
years 
pp
Intake 
X
Postpartum 
contraception 
counseling 
satisfaction survey
X
X
Device Insert
X
X
X
Exclusive 
breastfeeding 
X
X
X
X
X
X
Breastfeeding 
discontinuation
X
X
X
X
X
Retrospective 
Breastfeeding 
Discontinuation 
Chart Review Form
X
Contraceptive use
X
X
X
X
X
X
Diary collection
X
X
X
Mood (EPDS)
X
X
X
Sexual 
function 
(FSFI)
X
X
X
Bleeding 
log 
review
X
X
X

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7.2.  The primary study endpoint is also a safety endpoint: breastfeeding continuation 
through 8 weeks.  We have developed a Data Safety and Monitoring Plan related to 
these endpoints (please see below). 
7.3.  No exploratory endpoints will be conducted in this research. 
8. Research Setting
8.1.
Our study will be conducted at multiple clinical sites: the University of New 
Mexico Hospital, its affiliated clinics and the University of Utah Hospital and its 
affiliated clinics. These clinical sites are well versed in managing the competing 
demands of a busy clinical schedule and robust research. This site is part of a 
Clinical Translational Science Center and the project will be overseen by the 
University of New Mexico Department of Obstetrics and Gynecology, Family 
Planning Division with contribution to patient recruitment from the Division of 
Midwifery and the Department of Family and Community Medicine. The primary 
investigator of the study is Dr. Jamie Krashin and the faculty mentors are Dr. Eve 
Espey and Dr. Lawrence Leeman at UNM and Dr. David Turok at the University 
of Utah. Progress on the project will also be followed by the Fellowship in Family 
Planning as part of fellowship graduation requirements.
 
8.2 Patients may be recruited in the following locations/timeframes:  1) antenatal 
clinics, 2) visits to OB-Triage 2) on admission to L&D for delivery not in active 
labor or 4) during the first postpartum hours in the Ob-Gyn ward of the UNM and 
Utah’s Hospital.  Recruitment may occur remotely.  
8.2.The implant insertions will be performed in the UNM Hospital and the University 
of Utah Hospital for immediate  insertion group and in the affiliated clinics for the 
standard insertion group
Recruitment and research procedure locations:
UNM’s Labor and Delivery
UNM Westside Clinic
UNM Northeast Heights Clinic
UNM Southeast Heights Clinic
Los Lunas First Choice
UNM Women’s Health Clinic
UNM Faculty and Midwife Clinic
UNM Maternity and Family Planning 
Clinics
UNM Center for Reproductive Health
UNM Triage/ OB Special Care Units
UNM Family Practice Center / Tucker
First Nations Clinic
Utah’s Labor and Delivery
    Utah’s associated clinics
8.4. No community advisory board will participate in this study. 
8.5. No research will be conducted outside of UNM HSC and its affiliates. 
9. Resources Available

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9.1. The PI is a board certified obstetrician-gynecologist with subspecialty training in 
Family Planning.  She has a Master of Science in Clinical Research and was the 
PI on a 600-participant cohort study that was published in a leading OBGYN peer 
reviewed journal.  She recently published an analysis of immediate postpartum 
contraceptive implant initiation and breastfeeding continuation. Dr. Krashin spent 
the previous two years working on the US MEC as a guest researcher.  In that role, 
she presented the data behind CDC’s hormonal contraception and breastfeeding 
recommendations at the Academy of Breastfeeding Medicine’s Annual Meeting 
2017 and at Grand Rounds for the Medical University of South Carolina in 2018. 
Also, the Family Planning Research team at the University of New Mexico has 
successfully conducted a similar RCT of early versus standard insertion of 
levonorgestrel IUD and impact on breastfeeding. Similar enrollment and data 
collection policies will be employed for this study.
9.2. All licensed physicians/providers who will be inserting the implant are responsible 
for medical decision-making, ordering, and evaluation of necessary diagnostics 
and therapeutics.
9.3. There are ample patients available to participate in this trial as approximately 200 
of the 3000 women who deliver at the University of New Mexico have the ENG  
implant for postpartum contraception inserted before being discharged after 
delivery. The time that will be devoted to conducting and completing the research 
is 18 months. The research will be conducted at the UNM Hospital and its 
affiliated clinics and University of Utah Hospital and its affiliated clinics. The 
UNM and University of Utah systems have available medical and psychological 
resources for participants that might need it as a result of an anticipated 
consequences of the human research. In addition, all persons assisting with the 
research will be adequately informed about the protocol, the research procedures, 
and their duties and function through a process of training
10.Prior Approvals
10.1. The national office for the Fellowship in Family Planning approved the research 
as part for the requirement for completion of the fellowship. 
10.2. See attachment. 
10.3. No ionizing radiation will be used in this study.
10.4. No biological specimen will collected for this study. 
11.Multi-Site Research
11.1. UNM is the lead coordinating site and Dr. Krashin is the lead investigator. 
This will be a multi-site study in which University of Utah will be an external 
site for recruitment of participants. All sites have the most current version of 
the protocol, consent document and HIPAA authorization. All required 
approvals will be obtained by the UNM IRB and University of Utah’s IRB. 

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The University of Utah will have their side of the study reviewed by the 
University of Utah IRB and the University of New Mexico will have the UNM 
IRB reviewing this protocol. The only exchange of patient information is from 
the University of Utah to the University of New Mexico. All modifications 
will be communicated to the external sites and approved before the 
modifications are implemented. All engaged participating sites will safeguard 
data as required by local information security policies. All local site 
investigators will conduct the study appropriately. All non-compliance with 
the study protocol or applicable requirements will be reported in accordance 
with local policy.
11.2. We will have regularly scheduled contact bi-monthly and potentially 
monthly as the research progresses to ensure that any adverse events, 
problems, interim results, data monitoring, and closure of a study are 
communicated. 
11.3. NA.This is not an FDA regulated trial
12.Study Procedures 
12.1  NA
12.2 Patients may be recruited in the following locations/timeframes:  1) antenatal 
clinics, 2) visits to OB-Triage 2) on admission to L&D for delivery not in active labor 
or 4) during the first postpartum hours in the Ob-Gyn ward of the UNM Hospital and 
University of Utah Hospital and its associated clinics.

Patients may be asked for their contraceptive choice in any of these four venues, 
although ideally in antenatal clinics during prenatal care. When women decide on an 
implant as a postpartum contraceptive in any of these venues, the PCP (Ob-Gyn, 
Family Medicine physicians/residents and midwives) may discuss the patient’s 
interest in hearing about the study and may contact the research coordinator by a 
message in the EMR or by phone or in person to let her know that the patient is 
interested in hearing about the study. 

Additionally, the research coordinator will review antenatal clinic, OB Triage and 
inpatient (L&D and postpartum) lists to assess patients’ contraceptive plan through 
review of the EMR. The research coordinator may contact patients who have decided 
on a postpartum implant to assess her interest in participating in the study.  

If the patient expresses interest, the research coordinator will present the study and 
ask the patient for her interest in enrolling.  If interested, the research coordinator 
and/or a study co-investigator will explain the study, screen for eligibility and 
obtain informed consent. Participants can also be consented remotely by phone 
call or via zoom conference. In the case of remote consent, we will obtain written  
consent via e-mail or mail due to the current pandemic and research coordinators 
working from home. We will also allow participants to consent via e-signature via 
the eConsent feature in the UNM HSC REDCap system if they have that 
capability. The screen for eligibility will be done by interview and assessment of 
past medical history with standardized set of questions. 

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
Women will not be approached for study participation if they are in active labor.  
Women will be approached and enrolled, if interested, either prior to active labor 
(e.g., when admitted for induction of labor or scheduled cesarean delivery) or after 
delivery.

Once the woman is enrolled in the study a line will be added to the Antenatal 
Supplemental Visit Form stipulating the patient’s participation in the study and the 
coordinator’s phone number:  Ex: “Rivera-Montalvo study patient – page at 
admission ###-####**.”  This Form is a section of the EMR that is updated at each 
visit by the clinic provider with important/current antenatal issues; it is standard that 
the contraceptive plan for each patient is recorded here.
Identification of study patients on L&D

The PCP on L&D may identify study patients who self-identify as being in the 
study.  They will also be alerted by the “Study Patient” in the antepartum record if 
the patient has been enrolled antepartum.  They will notify the research coordinator 
who will carry a phone during working hours.  

A reproductive health on-call fellow/attending will be designated 24-7 to ensure 
randomization and implant insertion within 24 hours for those randomized to the 
immediate group.  After hours (nights and weekends), the research cell will forward 
to the reproductive health on-call fellow or attending.  In addition, the voice message 
for the research cell will direct callers to contact the reproductive health on-call 
fellow through Amion, the hospital online paging system. A calendar will specify 
which co-investigator is on call for study patients.

The PCP on L&D will call the research coordinator/call physician by phone or by 
text message that a study patient arrived on L&D for her birth. 

The research coordinator will review the list of admitted patients to L&D twice a 
day (8 AM and 4 PM) and once daily on Mother Baby Unit and Ob-Special care the 
(Ob-Gyn wards) to identify enrolled study patients. This modality has been used with 
other studies in the department of Ob-Gyn and has been successful.
Randomization

University of Utah coordinators will have access to UNM’s REDCap to obtain 
randomization and enter any data collected for their participants.

The research coordinator will access REDCap to obtain the randomization 
assignment for study patients (enrolled antepartum or on L&D not in labor) shortly 
after admission to L&D for a birth.  The reproductive health physician on call will be 
notified

For patients enrolled postpartum, the research coordinator will randomize the 
patient as soon after consent is signed or verbally agreed to and within 22 hours after 
birth to ensure implant placement for those randomized to the immediate group 
within 24 hours. For those who verbally agree, we will make an effort to obtain 
written consent via mail, e-mail, or eConsent in the UNM HSC REDCap system. 

The reproductive health physician on call will be notified to ensure placement of 
the implant within 24 hours; after hours, the reproductive health physician on call 
will also have access to the randomization sequence and will notify the research 
coordinator of the subject’s identification number.

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Implant insertion
The implant will be placed in accordance with the Federal Drug Administration 
(FDA) label instructions and only by providers who have completed the Merck 
training and are certified to insert the implant by Merck. 
Those allocated to the immediate group will obtain their implant in the hospital, by 
residents with attending supervision, fellows, attendings or certified nurse-midwives, 
and by obtaining the implant through the hospital pharmacy or the implants from the 
Family Medicine grant or LARC Mentoring Program for UNM participants. 
For those randomized to the standard insertion group, the implant will be provided 
in clinics as per clinic protocol.  For UNM participants without insurance or those 
whose insurance does not cover immediate implant insertion, a limited number of 
implants (33) will be provided through the Family Medicine grant and additional 
implants will be available via the LARC Mentoring Program. UNM and University 
of Utah  have established a process to enter all clinical study data via REDCap.
Follow-up procedures: 
A research staff will keep a record of contact information for all participants. The staff 
will schedule visits for standard insertions at 4 weeks postpartum, will contact care 
provider to let them know the patient is participating in the study and the date of the 
appointment for the implant insertion. We will schedule standard insertion at 4 weeks 
postpartum in order to have a 2 week period to reschedule the participant if necessary. 
UNM appointments can be made at the Center for Reproductive Health Clinic (CRH) 
for increased convenience and to improve follow up if a participant cannot return to 
her antepartum clinic.  
Research staff will contact participants randomized to the standard insertion group  
one week before the appointment to remind her of her appointment and will contact 
the care provider by a message in the EMR to let them know they date of the 
appointment for the implant insertion. Research staff will coordinate any necessary 
appointment rescheduling.  Research staff will track this information for the purpose 
of the study CONSORT flow diagram.  
Utah’s research coordinators will have access to UNM’s REDCap and will 
randomize and enter baseline data. They will also enter the study participants contact 
information (phone number or email) which is how they will receive the follow up 
study questionnaires.
UNM will call UNM participants and Utah will call Utah’s participants for the follow 
up for the contact periods at 2, 4, 8, 12, and 24 weeks postpartum will be made by 
each site’s research team to their respective study participants by phone calls, text 
messages or email. The text message and the emails will include a link to REDCap to 
access the follow up questionnaire to be completed by the participant. When/if the 
patient is contacted through phone call the UNM and Utah research staff will only 
contact their respective participants for completion of the questionnaires in REDCap.  

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The questionnaires will contain data about breastfeeding, postpartum depression, and 
sexual function.  A paper diary will be provided to aid the participant in daily recording 
of data. We will also include a retrospective data collection instrument to account for 
those we miss at the primary data collection points for breastfeeding information. If 
the primary questions have been answered either prospectively or retrospectively, then 
they get the normal prospective survey.  If participants do not meet this criteria or if 
they miss a previous survey, then they will receive a retrospective survey. The diary 
will be collected at 2, 4, and 8  weeks.  If possible, 2-3 good phone numbers will be 
obtained as well as addresses for each participant. Participants will have a phone 
number to contact study personnel at their specified site during standard work hours: 
Monday-Friday 8am- 4:30 pm with any concerns or adverse events. If they call after-
hours, a voicemail system will be available, and the participant will be contacted the 
next working day. 
Data collection instruments
Data collection 
instrument
Manner of 
collection
Timing
Included data
Enrollment form 
Medical chart 
review
After delivery
Participant & neonate 
medical history, delivery 
details 
In-person, 
telephone and/or 
online via UNM’s 
REDCap
At enrollment 
contraceptive history, 
contraceptive bridge-
methods, lactation 
history, lactation and 
work expectations
Contraceptive 
Counseling 
Survey
In-person, 
telephone and/or 
online via UNM’s 
REDCap
At enrollment and 4 weeks 
postpartum
Satisfaction with 
contraceptive counseling
Breastfeeding 
Survey
In-person, 
telephone and/or 
online via UNM’s 
REDCap
2, 4, 8, 12, 24 weeks 
postpartum
Breastfeeding 
continuation, exclusivity, 
reasons for 
discontinuation if 
applicable, infant weight, 
resumption of intercourse, 
and satisfaction with 
contraception
EPDS
In-person, 
telephone and/or 
online via UNM’s 
REDCap
2, 4, 8 weeks postpartum
Postpartum depression 
scale
FSFI
In-person, 
telephone and/or 
online via UNM’s 
REDCap
4, 8, 12 weeks postpartum
Sexual function scale

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Bleeding diary
Paper or UNM’s 
REDCap
Reviewed at 2, 4, 8 weeks.
Collected at 2, 4, and 8 
weeks
Bleeding patterns
Side effects
Retrospective 
Breastfeeding 
Survey
In-person, 
telephone and/or 
online via UNM’s 
REDCap
2, 4, 8, 12, 24 weeks 
postpartum
Breastfeeding 
continuation, exclusivity, 
reasons for 
discontinuation if 
applicable, infant weight, 
resumption of intercourse, 
and satisfaction with 
contraception
Retrospective 
Breastfeeding 
Discontinuation 
Chart Review 
Form
Medical Chart 
Review
Up to 1 year pp
Breastfeeding 
continuation if no 
response from survey.
Infant feeding data as 
clinically described in the 
infant chart up to 1 year* 
postpartum may be 
collected if no response to 
survey and no data is 
available in the patient’s 
chart.
*Infant age is defined as 0-1 year 
by the CDC
Retrospective 
Contraceptive 
Use Chart Review
Medical Chart 
Review
Up to years pp*
*Nexplanon can be used for up to 5 
years after insertion
Nexplanon use at any of 
the timepoints (2, 4, 8, 12, 
24 weeks postpartum).
We will review the 
mother’s chart up to 5 
years postpartum if 
contraceptive use data is 
not obtained from surveys 
or available from chart 
review within the first 
year postpartum.
13.Data Analysis
13.1 We will conduct a primary analysis per protocol and a secondary analysis per intention 
to treat. The rationale behind this strategy is to analyze both approaches and examine 
the result for consistency A Repeated measures ANOVA analysis will be used for 
continuation of breastfeeding. To evaluate secondary outcomes between the two 

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groups we will use the T-test, Wilcoxon Rank Sum test, Chi-squared test, or Fisher’s 
exact test as appropriate. Secondary outcomes to be evaluated are to compare time of 
exclusivity of breastfeeding, mix breastfeeding, factors associated with discontinuing 
breasts feeding, time of breastfeeding discontinuation and patient satisfaction with 
postpartum contraception counseling and with timing of placing the implant between 
both groups. If there are significant differences between treatment groups, 
multivariable linear (for continuous outcomes) and logistic (for dichotomous 
outcomes) regression will be utilized in addition to control for confounding.  
13.2 This study is a non-inferiority trial designed to demonstrate that immediate postpartum 
insertion of the ENG implant is non-inferior to standard ENG implant insertion with 
respect to the proportion of women who fail to breastfeed by 8 weeks after delivery. 
The failure rate for continuation of breastfeeding under the current treatment, standard 
insertion, is expected to be 30%. 
The following sample size determination and plan for data analysis was developed in 
conjunction the University of New Mexico Clinical and Translational Science Center 
(CTSC).The non-inferiority margin for both primary outcomes is 15%, meaning that 
immediate insertion can be regarded as non-inferior (in terms of breastfeeding 
continuation) to standard  insertion if the difference in rate with immediate insertion is 
no more than 15% worse than with  standard insertion.  To achieve 80% power with a 
1-sided Type 1 error of 5% utilizing the Z test (unpooled) 62 participants are required 
in each group for a total 124. Accounting for the expected loss of follow up of 20%, 
the total subjects 149, round to 150. We intend to enroll up to 200 participants due to 
unanticipated loss to follow up, so this should ensure that we have enough data for data 
analysis.
14.Provisions to Monitor the Data to Ensure the Safety of Subjects
A Data and Safety Monitoring Plan has been developed and will be led by Dr. Alan 
Waxman at the University of New Mexico, who is an independent physician. Dr. 
Waxman will monitor the study at least quarterly.  
The ENG implant is an FDA approved drug, which has a well-established record in 
breast feeding women. Early implant insertion reflects standard practice in many 
centers, including the University of New Mexico. The data monitored and reviewed 
will include enrollment and dropout rates, protocol deviations, review of subject 
symptoms, and preliminary analysis of the primary outcomes (continuation of 
breastfeeding at 8 weeks). The reports will include enrollment and dropout rates, 
protocol deviations, review of subject symptoms, and preliminary analysis of the 
primary outcomes. The trial will be stopped for a cessation of breastfeeding in more 
than 70% of the early insertion group in the first 8 weeks.  Any additional reports to 
the IRB will occur in response to specific events adverse events. Any serious adverse 
event defined as an event requiring re-hospitalization will require re-evaluation of the 
risk determination and continuation of the study. Adverse event reporting will follow 

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guidelines as proposed by Good Clinical Practice and collected as they occur or are 
reported by patients. These reports will be compiled for review by the DSMB quarterly; 
except for serious adverse events which will be reported to the IRB and DSMB within 
24 hours of the occurrence. All subjects will have access to clinical care which is not 
dependent on study participation and will be notified of the availability of that care. All 
data will be collected for quarterly reporting to the DSMB as well as for final data 
analysis and reporting. There may be times when we are required by law to share 
information. However, protected health information (PHI) will not be used in any 
published reports about this study.  
15.Withdrawal of Subjects
15.1 The research team will provide thorough screening to see if the patient will meet   
inclusion and exclusion criteria. If any circumstances arise such participant 
experiencing exclusion criteria during study participation or fail to follow study 
procedures such as having the implant placed or removed before the study ends, 
the participant will be notified and withdrawn from the study without their 
consent. 
15.2 Participants may have their implant removed at their request at any time. However, 
removal of the implant automatically terminates participation in the study and 
no data will be collected further. The data that was already collected from those 
participants that withdraws or was withdrawn from the study will be use data 
analysis.
15.3 NA 
15.4 Participants may withdraw from study involvement at any point in time and this 
will not affect their ability to obtain standard clinical care that day. All data points 
will be collected on the date of the procedure and therefore we anticipate loss to 
follow up and withdrawal rates will be low. Participants will be given the 
information on how to withdraw in the study consent.
15.5 The authorization for the use and disclosure of the participant health information 
for this study shall not expire unless the participant cancels this authorization.  
The health information will be used or disclosed as long as it is needed for this 
study.  However, the participant may withdraw her authorization at any time 
providing a notification to the UNM investigators in writing to notifying the study 
team about the withdrawal. To do this, a letter should be sent to:
Jamie Krashin, MD
Department of Obstetrics and Gynecology
MSC 10 5580, 1 University of New Mexico
       Albuquerque, New Mexico 87131-0001

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16.Data Management/Confidentiality
16.1. Only IRB-approved study team members will have access to study data and 
participant materials. 
16.2. A study identification number will be assigned to each participant in lieu of using 
their personal information for identification (e.g., name).  All participant data will 
be de-identified. Participant data will be stored separately from any identifiers to 
protect patient privacy. We will use de-identified cover sheets for document 
packets containing PHI.
16.3. This study will not be collecting information considered extremely sensitive or 
require additional protections such as HIV, genetic test results, mental health 
information, substance abuse information, and/or criminal records.  
16.4. Data will be entered into the data collection software, REDCap, by research staff. 
Research staff will have completed institutional training prior to initiation of the 
study. Additionally, only study staff will have access to the REDCap records. 
16.5. Study packets will be stored in a secure file cabinet located in the research office. 
These cabinets will be kept locked at all times. In a separately locked file cabinet, 
stored in the same room, the study consents will be stored. This second file 
cabinet is locked with a second, separate key from all other study materials.
16.6. The list that links participant information to the study identification number will 
be destroyed after data analysis is complete. Data will be stored for five years, 
and then will be destroyed. Study records of minors will be retained until the 
minor turns 22 years old, and then will be destroyed.
17.Data and Specimen Banking
NA, no data or specimens will be banked or archived locally for future use.
18.Risks to Subjects
18.1. The ENG implant has been associated with mild side effects including 
unpredictable bleeding patterns, mood swings, weight gain, acne, depressive 
mood, vaginitis, breast pain, viral infections, stomach pain, painful periods, 
nervousness, back pain, headache, dizziness, or nausea and vomiting.  In addition, 
the potential insertion procedure side effects and complications include pain, 
irritation, swelling, bruising, scaring, infection, nerve injury, implant break and 
then need for an extensive procedure for removal. Everyone taking part in the 
study will be followed carefully for any side effects. There are risks of stress, 
emotional distress, inconvenience and possible loss of privacy and confidentiality 
associated with participating in a research study. There is also the possible risk of 
decreased breast milk production.  Current but limited data suggest there is no 
decreased breast milk with progestin-only methods. 
The UNM Hospital and its affiliated clinics are staffed by providers trained in 
postpartum contraception. 

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The implant has side effects – because of the small amount of hormone, it is 
unlikely and has not been shown in studies to increase the risk of depression. (29)
Postpartum implant insertion will be inserted according to the standardized 
procedure approved by the FDA and only by providers certified to insert the 
implant by Merck.
Regarding data collected for assessment of postpartum mood:
EPDS results will be scored weekly as they are obtained. The research 
coordinator will forward scores to the on-call study co-investigator as soon as 
possible/on the day they are obtained.  For scores <10 (with a score of 0 for 
question 10) no immediate action is needed, and the study participant will be 
reevaluated at the next study interval. For scores < or = to 10 (with a score of 0 
for question 10), the co-investigator will 1) call the study participant as soon as 
possible/on the day they are obtained and offer referral to counseling and/orfor 
suicidal ideation, to the crisis hotline number (National Suicide Prevention 
Hotline 1.800.273.8255).  For women without suicidal ideation or acute crisis, 
the study co-investigator will offer an appointment in the OB-GYN perinatal 
mood disorders clinic, Journeys with a counselor within the next 5 days.  Study 
participants with a non-zero score for question 10 will be contacted by the study 
co-investigator as soon as possible/on the day they are obtained by telephone 
and suicide risk will be assessed using the SAHMSA SAFE-T 5-step method 
(23). For moderate and high-risk study participants, immediate referral to UNM 
Psychiatric Urgent Care Clinic or Psychiatric Emergency Services will be made 
in addition to provision of the crisis hotline number above.  All study co-
investigators are competent to manage patient responses on the Edinburgh.
18.2. NA, no procedures may have risks to the subjects that are currently unforeseeable.
18.3. NA, no procedures may have risks to an embryo or fetus should the subject be or 
become pregnant.  The implant is a contraceptive method. 
18.4. NA, there is no risks to others who are not subjects.
18.5. To minimize the probability or magnitude of risks of this study the insertion will 
be performed as per FDA guidelines. However, side effects cannot be prevented. 
19.Potential Benefits to Subjects
19.1. The completion of this study will show whether women randomized to immediate 
implant insertion is non-inferior in terms of breastfeeding continuation through 8 
weeks postpartum when compared to women randomized standard insertion. The 
contribution of the proposed research is to determine if inserting the implant in 
the first 24 hours postpartum interfere with continuation of lactation. This 
contribution to the literature is significant because current recommendation and 
previous studies are limited and insufficient. 

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19.2
There may not be direct benefit to the study participants.  However, their 
participation will help in the treatment of future patients with an understanding of 
how an implant affects breastfeeding and on the optimal timing of starting the 
implant to prevent unplanned pregnancies.  
19.3
The direct benefits from the contraceptive implant include improved access 
to the device in either randomization arm: immediate access prior to hospital 
discharge or help from research staff scheduling clinic appointment for placement.  
Direct medical benefits from the implant include improved autonomy related to 
their reproductive health, ability to control when they want to become pregnant 
again given the high contraceptive effectiveness and ease of use of the implant, 
longer intervals between pregnancies which is associated with improved maternal 
and neonatal outcomes, and improvement in menstrual bleeding/reduction in 
anemia.  The implant is a popular contraceptive choice for adolescents, who often 
prefer a long-acting method that does not require a pelvic examination.  These 
benefits of the contraceptive implant are part of the reason that minors do not need 
parental consent to have the implant placed clinically.
20.Recruitment Methods
20.1. (Also described under “procedures” in Section 12.)  Patients may be recruited in 
the following locations/timeframes:  1) antenatal clinics, 2) visits to OB-Triage 2) 
on admission to L&D for delivery not in active labor or 4) during the first 
postpartum hours in the Ob-Gyn ward of the UNM Hospital and University of Utah 
Hospital.

Patients may be asked for their contraceptive choice in any of these four venues, 
although ideally in antenatal clinics during prenatal care. When women decide on 
an implant as a postpartum contraceptive in any of these venues, the PCP (Ob-Gyn, 
Family Medicine physicians/residents and midwives) may discuss the patient’s 
interest in hearing about the study and may contact the research coordinator by a 
message in the EMR or by phone or in person to let her know that the patient is 
interested in hearing about the study. 

Additionally, the research coordinator will review antenatal clinic, OB Triage and 
inpatient (L&D and postpartum) lists to assess patients’ contraceptive plan through 
review of the EMR. The research coordinator may contact patients who have 
decided on a postpartum implant to assess her interest in participating in the study.  

If the patient expresses interest, the research coordinator will present the study and 
ask the patient for her interest in enrolling.  If interested, the research coordinator 
and/or a study co-investigator will explain the study, screen the patient for 
eligibility and obtain informed written or electronically signed consent.

Women will not be approached for study participation if they are in active labor.  
Women will be approached and enrolled, if interested, either prior to active labor 
(e.g., when admitted for induction of labor or scheduled cesarean delivery) or after 
delivery.

We will not enroll patients who are under sedation.  Most participants will be 
enrolled and undergo informed consent in the antenatal period; some will be 

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enrolled when they are admitted to labor and delivery not in active labor; neither 
of these two groups would be under sedation.  For those “up to 22 hours after 
delivery,” we will only enroll women who have not received sedation within a 4-
hour period.

Once the woman is enrolled in the study a line will be added to the Antenatal 
Supplemental Visit Form stipulating the patient’s participation in the study and the 
coordinator’s phone number:  Ex:  Rivera-Montalvo study patient – page at 
admission ###-####**.  This Form is a section of the EMR that is updated at each 
visit by the clinic provider with important/current antenatal issues; it is standard 
that the contraceptive plan for each patient is recorded here.
Identification of study patients on L&D

The PCP on L&D may identify study patients who self-identify as being in the 
study.  They will also be alerted by the “Study Patient” in the antepartum record if 
the patient has been enrolled antepartum.  They will notify the research coordinator 
who will carry a phone during working hours.  

A reproductive health on-call fellow/attending will be designated 24-7 to ensure 
randomization and implant insertion within 24 hours for those randomized to the 
immediate group.  After hours (nights and weekends), the research cell will forward 
to the reproductive health on-call fellow or attending.  In addition, the voice 
message for the research cell will direct callers to contact the reproductive health 
on-call fellow through Amion, the hospital online paging system. A calendar will 
specify which co-investigator is on call for study patients.

The PCP on L&D will call the research coordinator/call physician by phone or by 
text message that a study patient arrived on L&D for her birth. 
20.2. The research coordinator will review the list of admitted patients to L&D twice a 
day (8 AM and 4 PM) and once daily on Mother Baby Unit and Ob-Special care 
the (Ob-Gyn wards) to identify enrolled study patients. This modality has been 
used with other studies in the department of Ob-Gyn and has been successful. 
20.3. Brochures and flyers will be used to recruit participants. See attached documents. 
21.Provisions to Protect the Privacy Interests of Subjects
21.1. We will take measures to protect the security of all personal information, but we 
cannot guarantee confidentiality of all study data. To minimize the privacy risk, 
the research team will reassure the patient of the following:  
Information contained in study records is used by study staff alone. The 
University of New Mexico and other recruitment sites’ Institutional Review 
Board (IRB) that oversee human subject research and/or other entities may be 
permitted to access records. Additionally, de-identified data will be shared for 
reporting to the DSMB, if needed, as well as for final data analysis and reporting. 
There may be times when we are required by law to share information. However, 
protected health information (PHI) will not be used in any published reports about 
this study.  

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There will be a need for medical record access to assess patient demographics 
and clinical outcomes. Most study data will be stored in the HIPAA-secure de-
identified online REDCap database. Any printed study data (such as signed 
consent forms) will be secured in a locked cabinet/file-box and only those directly 
involved in the study will have access to this including the investigators who will 
process it. Only de-identified data will be saved under a secure file on a computer 
requiring a log-in password. Data will be stored for five years, and then will be 
destroyed. 
21.2. A 
description 
of 
this 
clinical 
trial 
will 
be 
available 
on 
http://www.ClinicalTrials.gov, as required by U.S. Law. 
21.3. A study participant’s privacy interests during recruitment and data collection will 
be protected through the following measures:
The study will be thoroughly explained to the potential participant using the 
HRPO-approved consent form.  As part of the informed consent process, the 
recruiting co-investigator or research assistant will provide as much time as 
needed for the potential participant to consider study participation.  If any privacy 
interests are expressed by the patient, they will be addressed immediately by the 
research team member and if necessary, the issue will also be considered by the 
principal investigator.  
Participants will be recruited and consented in a private clinic setting. This will 
also include the recruitment and screening process as well as the data collection 
procedures.
22.Economic Burden to Subjects
22.1. Participant’s third party payer (i.e. insurance company) is responsible for all the 
costs related to the implant and clinical treatment.  This would be the case 
regardless of study involvement.   
New Mexico Medicaid reimburses for immediate postpartum implant placement 
(prior to hospital discharge) and will cover all costs related to the implant and 
clinical treatment.  Private insurers do not cover the costs. We will be enrolling 
participants that are Medicaid, uninsured, underinsured and private insurers, until 
the supply of 33 implants run out.  We do anticipate receiving additional no-cost 
implants; if this occurs, we will continue enrollment of private insured and un or 
under-insured women. Please see the table below.
Responsible Party
Research Procedures
Number 
of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Immediate implant insertion
75
     
     
     
     

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Responsible Party
Standard of Care Procedures
Number 
of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Implant insertion at 4-6 weeks
75
     
     
     
     
     
     
     
     
     
     
     
     
     
     
22.2. No other costs to participants are anticipated
22.3. The participants and/or the third party will be charged for the implant device in 
case the participant cannot afford the implant or the implant is not covered by the 
third party (insurance) for the immediate insertion, there will be 33 of implants 
out of charge paid by a private grant. Additional implants are available via the 
LARC Mentoring Program, However, this is subject to availability and once the 
product is out of stock no more implants will be available from the grant or the 
LARC Mentoring Program.  
22.4. Participants will not be billed for the cost of tests and procedures directly 
associated with this study. However, reimbursement for all related costs of care 
will be sought from the patient’s insurer, managed care plan, or other benefits 
program. If they do not have insurance, they may be responsible for these costs. 
Patients will also be responsible for any associated co-payments or deductibles 
required by their insurance. 
23.Compensation
In return for the participant’s time and the inconvenience of participating in this study, 
the participant will be paid a total of $40 to participate in this research study. This 
incentive will be divided in two gift cards of $20. The first gift card will be given at the 
time of enrollment. The second gift card of $20 will be given after completing the 8 
week follow up. In the event that timeline of compensation is changed, the research 
team will send a letter to the affected participants to notify them of the change. 
Participants that have surpassed the new date of compensation will be paid immediately 
and those who have not will be paid at the time of completion of the surveys at that 
time. 
24.Compensation for Research-Related Injury
In the event that the patient has an injury or illness that is caused by participation in 
this study, patients will be verbally reminded of the following during the consent 

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process:  reimbursement for all related costs of care will be sought from the patient’s 
insurer, managed care plan, or other benefits program. If they do not have insurance, 
they may be responsible for these costs. Patients will also be responsible for any 
associated co-payments or deductibles required by their insurance.
25.Consent Process
25.1.1. The inclusion and exclusion criteria for study participation will be reviewed 
by a member of the research team to confirm eligibility. Prior to consent, the study 
will be described verbally to women, and potential subjects will receive a copy of 
the consent form to read.  If patients are comfortable enrolling in the study at that 
point, they may do so.  All potential participants will be reassured that declining 
study participation will have no effect on the care that they receive.  If patients 
choose not to participate, they will not be approached again unless they broach the 
subject.  Women who elect to participate will be informed about the standard risks, 
benefits and alternatives of the procedure per standard of care. Co-investigators or 
trained research staff will follow HRPO regulations for written documentation of 
consent or verbal consent. For women ages 13-17, we will obtain parental consent 
which could also occur verbally by phone and collected via mail or e-mail. 
Electronic consent will be noted on the updated consent form.  Due to the pandemic, 
research coordinators are mainly working from home and going through the consent 
with participants by phone for the safety of everyone.  Privacy is still maintained 
as the coordinator ensures they have a place they can talk privately by phone.  
25.1.2. The consent discussion will take approximately 5-10 minutes after the consent 
has been read by the potential participant. Research staff will review the consent 
with the potential participant and provide ample opportunity for the subject to ask 
questions in a private setting. 
25.1.3  Steps that will be taken to minimize the possibility of coercion or undue 
influence include providing ample opportunity for the subject to ask questions they 
may have about research, providing time for the possible participants to think about 
participating in the study and providing privacy for subjects.
25.1.4 Research staff will confirm the participant’s interest and allow more 
opportunity for questions before the consent form is finally signed or electronically 
signed by the patient. 
25.1.5 Steps that will be taken to ensure understanding include providing ample time 
for the potential participant to read the consent.  The recruiting co-investigator or 
trained research assistant will speak directly to potential subjects about the aims of 
the study and participant involvement in this study.  Potential subjects will be asked 
if they understand the study and its importance, and side effects will also be 
emphasized as well as the voluntary nature of participation. 

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25.1.6 Spanish-speaking patients will be recruited using a UNMH certified Spanish 
interpreter service or a fluent Spanish-speaking research team member. Spanish-
speaking patients will be provided with a hard or emailed copy of the Spanish 
consent form.
25.1.7 After counseling, potential candidates will be asked to teach back as a proof of 
understanding. . 
Subjects not fluent in English
25.1.8 This study will enroll English and Spanish speaking patients only. 
25.1.9 Spanish-speaking patients will be recruited using a UNMH certified Spanish 
interpreter service or a fluent Spanish-speaking research team member. Spanish-
speaking patients will be provided with a hard copy of the Spanish consent form.
25.1.10 Study materials will be translated into Spanish after the English versions are 
approved. Consent forms will be available in English and in Spanish. 
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally Authorized 
Representative
25.1.11- 25.1.20  We will not enroll cognitively impaired women. 
Subjects who are not yet adults (infants, children, teenagers)
25.1.21 Minor females from ages 13-17 will be included in the study. 
25.1.22 As per the “SOP: Legally Authorized Representatives, Children, and  
Guardians (HRP-013)” all people under the age of 18 are minors. 
25.1.24 Consent will obtained by biologic or adoptive parents or an individual legally 
authorized to consent on behalf of the child. 
25.1.25 All children enrolled in the study must be capable to provide assent.
25.1.26 Assent will be obtained from all of the children in order to enroll them in the 
study along with parental consent. 
25.1.27 The process for obtaining assent will follow the same process for obtaining  
consent. The study will be explained to the child in simple language. A copy 
of  the consent/ assent form will be given, questions regarding the study will 
be  answer and in the case the participant will need time to think more about  
participating in the study time will be given.  
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of consent 
will be altered) 
A partial waiver of consent for screening/recruitment will be obtained.
26.Documentation of Consent

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.
26.1 Consent will be obtained in-person or electronically during the current pandemic. 
The patient will be provided with a physical or electronic copy of the consent form 
and will read and discuss the study with trained research staff. Before signing the 
consent form, staff will confirm the patient’s interests in participating as well as 
answer any remaining questions. After signing or e-signing the consent form, the 
patient will receive a copy for their own personal records. 
26.2 This study will not be collecting tissue samples. 
26.3 NA
27.Study Test Results/Incidental Findings
27.1 Results will not be shared with participants.  
27.2 Incidental Findings: Based upon the nature of the research, and the intervention 
that will be performed, we anticipate that the research may not result in incidental 
findings. However, if an incidental finding that threatened the life of a participant 
is found this will be disclosed with the participant. All other clinical care 
provided, including the technique to place the implant and reporting of any 
incidental findings will be handled according to routine clinical care.
   
28. Sharing Study Progress or Results with Subjects
28.1. We will not directly share study results with participants; however, all participants 
will be told, during the informed consent process, that results for this study will 
be uploaded to ClinicalTrial.gov, which is publicly accessible.
28.2 We will not directly share study summary with participants; however, all 
participants will be told, during the informed consent process, that results for this 
study will be uploaded to ClinicalTrial.gov, which is publicly accessible.
29.Inclusion of Vulnerable Populations
29.1    This study will include postpartum females ages 13 years and older. This study 
seeks to include adolescent population since postpartum contraception is 
important to this population as well as adult women. This research study 
focuses on women seeking voluntary postpartum contraception options. This 
study is inclusive to all adolescent girls and women 13 years and older of 
varying ethnic backgrounds. It may happen that a participant is a student or an 
employee. However, this study is not intended solely in these populations. 
Research staff will approach these girls and women to assess their 1) interest 
and 2) meet eligibility criteria as determined by staff and their provider. Once 
the possible participant show interest, the research staff will go forward with 
the enrollment to reduce coercion, research staff will conduct a thorough 
consent process and reiterate that their participating is completely voluntary.

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1. This study will not include women who are incarcerated, or children 
that are wards of the state or any other organization similar. 
2. This study will not include women with cognitive impairments 
and/or are unable to understand the consent process. 
3. No neonates will be involved in this research. 
30.
Community-Based Participatory Research
NA
31.
Research Involving American Indian/Native Populations
31.1 This research study focuses on females seeking postpartum contraception 
options. This study is inclusive to all girls and women 13 years and older of 
varying ethnic backgrounds so long as they are English or Spanish speaking. 
This study does not focus solely on women of American Indian heritage.
32.
Transnational Research
NA
33.
Drugs or Devices
33.1 This research involve using ENG implants devise in all participants. The 
implants for immediate insertion will be stored at the UNM Hospital 
pharmacy. The implants for standard insertion will be stored at the affiliated 
clinics. The implants given by the Family Medicine grant are stored in the 
Family Medicine faculty Room in Labor and Delivery area. Implants provided 
by the LARC Mentoring Program will be stored on Mother Baby Unit.
33.2 No investigational drug will be used in this study. 
33.3 No drugs will be involved in this study. 
33.4 See device check list. 
34.
Principal Investigator’s Assurance
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that:
☒ The information supplied in this form and attachments are complete and correct.  
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements. 

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 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security Best 
Practices, including:
1. Best Practice for data collection is for it to be directly entered onto a data collection 
form that is in a secured access folder on an HS drive behind a firewall, or in a 
secure UNM Data Security approved system such as RedCap.
2. Data collection of de-identified data, if done in a clinical setting or other setting that 
does not allow direct entry into a secured system, may be done temporarily using a 
personal or university owned electronic storage device or hard copy document. The 
important security safeguard is that no identifiers be include if the data is 
entered or stored using an untrusted device or storage.
3. Permanent (during data analysis, after study closure) storage must reside on HSC 
central IT managed storage. Processing of data (aggregation, etc.) are to be carried 
out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more of 
following safeguards: access logs, encryption keys, backups, business continuity 
and disaster recovery capabilities.
4. Alternate storage media must be approve by HSC IT Security as meeting or exceeding 
HSC central IT provided security safeguards.

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Checklist Section
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research.
I.
Waivers or Alterations of Consent, Assent, and HIPAA Authorization
A. Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you 
can review private information to identify potential subjects and/or determine 
eligibility prior to approaching potential subjects for consent or parental permission.
1. Describe the data source that you need to review (e.g., medical records):
UNM Medical records through PowerChart and postpartum floor schedule
2. Describe the purpose for the review (e.g., screening):
Screening and recruitment to determine eligibility prior to approaching 
potential subjects for consent.
3. Describe who will conducting the reviews (e.g., investigators, research staff):
UNM research staff will be conducting review for recruitment purposes.
4. Do all persons who will be conducting the reviews already have permitted 
access to the data source?
 Yes
 No. Explain:      
5. Verify that each of the following are true or provide an alternate justification 
for the underlined regulatory criteria:
a) The activity involves no more than minimal risk to the subjects because 
the records review itself is non-invasive and the results of the records 
review will not be used for any purposes other than those described 
above.
 True
 Other justification:      
b) The waiver or alteration will not adversely affect the rights and welfare 
of the subjects because eligible subjects will be approached for consent 
to participate in the research and are free to decline.  Further, the 
information accessed during the records review will not be disclosed to 
anyone without a legitimate purpose (e.g., verification of eligibility).
 True

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 Other justification:      
c) The research could not practicably be carried out without the waiver or 
alteration because there is no other reasonably efficient and effective 
way to identify who to approach for possible participation in the 
research.  
 True
 Other justification:      
d) Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider participation.  
(Regulatory criteria: Whenever appropriate, the subjects will be 
provided with additional pertinent information after participation.)
 True
 Other justification:      
Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will review 
to identify potential subjects and/or determine eligibility include Protected Health 
Information (PHI).
6. Will you be recording any PHI when conducting the records review to identify 
potential subjects and/or determine eligibility?
 Yes. Describe: We will only record the reason the patient was not eligible 
and their name in order to avoid reviewing a patient’s information more than 
once.
 No
7. If you answered “Yes” to question 6 above, please describe when you will 
destroy identifiers (must be the earliest opportunity consistent with the conduct 
of the research) or provide justification for why they must be retained:
We will destroy identifiers once the study is complete and closed with the IRB.
8. The PHI accessed or recorded for identification/screening purposes will not be 
reused or disclosed to (shared with) any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under 
the Privacy Rule.
 True
 False

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II. Vulnerable Populations
A. Children
Complete this checklist if the subject population will include children.
i.
Select the category of research that you believe this research falls within and 
provide justification for any associated criteria.  If there are different 
assessments for different groups of children or arms (e.g., placebo versus drug), 
include a memo to provide an assessment for each group.  
 Research not involving greater than minimal risk. (Minimal risk means 
that the probability and magnitude of harm or discomfort anticipated in 
the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical 
or psychological examinations or tests.)
 Research involving greater than minimal risk but presenting the prospect 
of direct benefit to the individual subjects.
Provide justification for each of the following criteria:
a.
The risk is justified by the anticipated benefit to the subjects:
     
b. The relation of the anticipated benefit to the risk is at least as 
favorable to the subjects as that presented by available 
alternative approaches:
     
 Research involving greater than minimal risk and no prospect of direct 
benefit to individual subjects, but likely to yield generalizable 
knowledge about the subject's disorder or condition.
Provide justification for each of the following criteria:
o
The risk represents a minor increase over minimal risk:
     
o
The intervention or procedure presents experiences to subjects 
that are reasonably commensurate with those inherent in their 
actual or expected medical, dental, psychological, social, or 
educational situations:
     

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o
The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition which is of 
vital importance for the understanding or amelioration of the 
subjects' disorder or condition
     
III.    Medical Devices
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  
If more than one medical device is being evaluated, provide the requested information for each.
A. Device Name:  Nexplanon
B. Manufacturer:  Merck & Co., Inc.
C. Does the research involve a Significant Risk Device under an IDE?
 Yes. Include documentation of the FDA approval of the IDE with your submission.  
Acceptable methods of documentation include: (1) FDA letter noting IDE number 
and approval status; (2) Industry sponsor letter noting IDE number and FDA 
approval status; or (3) FDA-approved industry sponsor protocol with IDE number 
noted 
 No
D. Is the research IDE-exempt?
 Yes. Include a FDA letter with your submission noting the determination that the 
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator) 
justifying why they believe the research is IDE-exempt*.  
 No
E. Does the research involve a Non-Significant Risk (NSR) Device?
 Yes. Include a FDA letter with your submission noting the determination that the 
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying why 
they believe the research is NSR**.  
 No
* This FDA guidance includes a description for when a device study is exempt from the 
IDE requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf 
**This FDA guidance includes information on how to differentiate between Significant 
Risk and Non-Significant Risk device studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf

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1. Data Transfer/Sharing (Checklist)
Complete this checklist if the research involves transferring/sharing of data with an external 
entity (institution, company, etc.). 
A. Will data be transferred/shared with an external entity (institution, company, etc.)?  
 Yes
 No. The remainder of this section does not apply. 
B. Indicate if the data is incoming and/or outgoing: incoming  
C. Provide the name of the entity that data will be transferred/shared with: University of 
Utah
D. Provide the contact name, email and phone number with whom data is being             
transferred/shared with: Marie Gibson, Marie.Gibson@hsc.utah.edu
E. Who is responsible for transmission of the data? Utah’s approved study team members     
F. Who is responsible for receiving the data? UNM’s approved study team members
G. Describe how the data will be transferred/shared. Please note data cannot be 
transferred/shared without assistance from UNM HSC IT. Requesting HSC Central IT 
Transfer is detailed on the Sponsored Projects website:  Through UNM’s REDCap, 
Utah’s study team members will be set up as a UNM affiliate to gain access to UNM’s 
REDCap database to enter the Utah’s study participant’s email or phone number, the 
REDCap electronic survey will then be sent directly to the study participant for them to 
complete the electronic survey and the data will automatically load into UNM’s REDCap 
database. An approved Utah study team member that is a UNM affiliate with a login to 
UNM’s REDCap could also enter the survey data in the case of the data being collected 
in person or over the phone.       
H. For data being transferred/shared with outside locations or entities, describe the 
following: NA

Where is data storage and how will it be maintained in a secure manner (i.e. 
encryption, password protection, use of Qualtrics or REDCap, etc)?      

What is method in which data will be collected and stored (i.e. electronic, hard 
copy, etc)?           

How long will the data be stored?           

Who will have access to data?        
I.
 Please list all specific data elements, variables, etc. to be sent out and/or received. 
Indicate if the data contains identifiers and health information. Please note that identifiers 
that MUST be removed to make health information de-identified are as follows: Names, 
All geographic subdivision smaller than a State, All elements of year (except year), 
Telephone, Fax numbers, E-mail addresses, Social Security, Medical record number, 
Health plan beneficiary, Account numbers, Certificate/license numbers, Vehicle 
identifiers and serial numbers, Device identifiers and serial numbers, Web URLs, IP 
address numbers, Biometric identifiers, full face photographic images, and Any other 
unique identifying number, characteristic or code.)   Names, emails, phone numbers, 
appointment dates/times.  All data collected through UNM's RedCap database.   
J.
If the research requires the access, use, or disclosure of any of the 18 individually 
identifiable protected health information (PHI) identifiers that can be used to identify, 

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contact, or locate a person (e.g., name, medical record number, etc.), are the subjects 
going to consent to or authorize the disclosure of their individually identifiable health 
information?  Participants will consent to disclose their individual identifiable 
information.
a.
Or is HIPAA authorization altered or waived?          
K. What is the classification of the data (de-identified, limited data set, protected health 
information, other). Protected health information
L. Does the request to transfer/share data include clinical data that belongs to the UNM 
Health Systems? The data is incoming, it does not belong to UNM Health Systems.
M. Does the data to be transferred/shared include information about patients seen at external 
health system or at a third party medical provider? The data is incoming, from Utah, an 
external health system.
N. Is the external entity a “covered entity”?   Yes, University of Utah
O. Is the data that is going to be transferred/shared owned or partially owned by another 
party or have any type of restrictions including regulatory restrictions (i.e. HIPAA, 
FERPA, etc.)?      
P. Is the data publically available? If yes, please provide details: No
Q. Does the data include information about substance abuse treatment, sexually transmitted 
diseases, genetic testing results, HIV/AIDS testing results, and/or mental health?   Yes 
 
References
1. American College of Obstetricians and Gynecologists. ACOG committee opinion 736, 
Optimizing Postpartum Care. Washington, DC: American College of Obstetricians and 
Gynecologists. 2018 May; 131(5):140-150.
2. Breastfeeding SO. Breastfeeding and the Use of Human Milk. Pediatrics. 2012 Mar 
1;129(3):827–41.
 
3. AAFP Releases Position Paper on Breastfeeding Am Fam Physician. 2015 Jan 1;91(1):56-
57.
4. Optimizing support for breastfeeding as part of obstetric practice. ACOG Committee 
Opinion No. 756. American College of Obstetricians and Gynecologists. Obstet Gynecol 
2018;132:187–96.
5. World Health Organization. Infant and young child feeding: Model Chapter for textbooks 
for medical students and allied health professionals. Geneva: World Health Organization; 
2009:3-4. 
 

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6. CDC. 2018 Breastfeeding Report Card [Internet]. Centers for Disease Control and 
Prevention. 
2018 
[cited 
2018 
Nov 
10]. 
Available 
from: 
https://www.cdc.gov/breastfeeding/data/reportcard.htm
 
7. Chapman DJ, Pérez-Escamilla R. Maternal Perception of the Onset of Lactation Is a Valid, 
Public Health Indicator of Lactogenesis Stage II. The Journal of Nutrition. 2000 Dec 
1;130(12):2972–80.
8. Curtis KM, Tepper NK, Jatlaoui TC, et al; Centers for Disease Control and Prevention. US 
Medical Eligibility Criteria (USMEC) for contraceptive use, 2016. MMWR Recomm Rep. 
2016 Jul 29;65(3):1-103
 
9. Cunningham FG, Leveno KJ, Bloom SL, Dashe JS, Hoffman BL, Casey BM, et al. 
Contraception. In: Williams Obstetrics, 25e [Internet]. New York, NY: McGraw-Hill 
Education; 
2018 
[cited 
2018 
Nov 
10]. 
Available 
from: 
obgyn.mhmedical.com/content.aspx?aid=1151917774
10. Turok DK, Leeman L, Sanders JN, Thaxton L, Eggebroten JL, Yonke N, et al. Immediate 
postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a 
noninferiority randomized controlled trial. American Journal of Obstetrics and 
Gynecology. 2017 Dec;217(6):665.1-665.e8.
 
11. Sothornwit J, Werawatakul Y, Kaewrudee S, Lumbiganon P, Laopaiboon M. Immediate 
versus delayed postpartum insertion of contraceptive implant for contraception. Cochrane 
Database of Systematic Reviews [Internet]. 2017 [cited 2018 Nov 10];(4). Available from: 
http://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011913.pub2/abstract 
12. 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. Obstetrics & Gynecology. 2011 May;117(5):1114–21.
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