Patient Centered Postpartum Contraception App
Conditions: Contraceptive Usage
Sponsor: University of Chicago

 
Postpartum Pregnancy App  
Mellisa Gilliam MD, MPH 
Brandon J. Hill, PhD 
 
NCT03402217 
Approved 3/7/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1.0 
Background 
 
Short Interpregnancy Intervals have Adverse Consequences for Adolescents. Healthy People 
2020 identifies short interpregnancy intervals (IPIs), i.e., pregnancies within 18 months of a 
previous birth, as an issue of national importance [1]. Short IPIs pose risks for mothers and 
newborns alike [2] including preterm birth, low birth weight, small for gestational age, and 
placental abruption [3-5]. IPIs less than 12 months increase risk of neonatal death [6]. One in 
three American women ages 15-44 have short IPIs [7] Short IPIs disproportionately affect low 
income, undereducated, women of color [8] accounting for an estimated 8% of low birth weight 
and preterm infants among African American and Hispanic mothers [9]. However, adolescents 
(ages 15-25) bear the greatest burden [3, 10]. With one in five births to adolescents a repeat 
birth [7], over two thirds following short IPIs [11-13] leaving young mothers to care for multiple 
babies. Postpartum contraception significantly, and perhaps uniquely, lengthens IPIs [14-16]. 
Injectables reduce short IPIs, with only 14.2% of postpartum adolescent depot 
medroxyprogesterone acetate (DMPA) users with short IPIs [17]. Women using long acting 
reversible contraception (LARC), implants and intrauterine devices (IUDs), have optimal IPIs 
compared to users of oral contraceptive pills and condoms [18]. Initiation of contraception prior 
to hospital discharge is a crucial strategy, as 10-40% of women do not attend a postpartum 
visit [19]; 50% of women resume sexual activity before the standard postpartum visit [20, 21] 
and ovulation can return by postpartum day 25 [22]. 
 
A.2. Research and New Policies Support Immediate Postpartum Contraception. All contraceptive 
methods, save combined hormonal contraception, are safe for use within 48 hours of delivery. 
Immediate postpartum implant use independently predicts longer IPIs in adolescents [25] as 
well as general study populations [18]. Significant research demonstrates adolescent interest in 
immediate postpartum LARC [26], as well as its cost effectiveness in both adolescent and 
general populations of women [27-29]. Immediate postpartum IUD placement, despite 
expulsion risk, was found effective in randomized control trials of immediate versus delayed 
placement, with equal rates of use at six months post vaginal and post cesarean delivery [30, 
31]. However, our team has identified several barriers to receiving IUDs for adolescents after 
hospital discharge, including outdated IUD eligibility requirements and lack of insurance 
coverage [23]. Hitherto, Medicaid reimbursement policy bundles payment within a global 
delivery fee, significantly hindering immediate LARC placement [32, 33]. Now, seventeen states, 
including Illinois, and the District of Columbia allow providers to bill for immediate LARC 
placement. 
 
A.3. A History of Coercive Contraceptive Practices Calls for Patient-Centered Postpartum 
Contraceptive Care. Yet, caution is needed given a long history of contraceptive coercion of low-
income communities. In 2001, the Institute of Medicine (IOM) published Crossing the Quality 
Chasm, highlighting patient-centered care as a model for improving quality of care [34]. Within 
this model, care is respectful and responsive to individual patient preferences, needs, and 
values. Patients are actively engaged in making decisions about their health care and 
continuously informed and educated on all the care options [35, 36]. Significant research shows 
the benefits of “patient activation” and “engagement”. Actively engaged patients have lower 
healthcare utilization [37], greater satisfaction [38, 39], and better health outcomes [40-42]. 
Patient-centered approaches have been advocated for within contraception counseling and 
delivery [43, 44] and positively influences adolescent contraceptive use [45]. 
 

A.4. Current Provider Practices May Limit Patient-Centered Postpartum Care. Provider 
practices can limit patient-centered care through contraceptive underuse and overuse. Only 
50% of obstetrician gynecologists offer implants at all due to lack of patient interest and provider 
training [46]. Despite research to the contrary [47], progestin-only methods such as DMPA have 
been denied due to concerns about lactogenesis or hormones in breast milk [30]. Surveys of 
obstetrician gynecologists and family physicians show lack of knowledge of LARC placement 
[48]. Despite endorsement by major professional organizations such as the American College of 
Obstetricians and Gynecologists (ACOG) and the CDC, many clinicians deny adolescents 
LARC [49]. Yet, as barriers to contraception decrease there is also a risk of contraceptive 
overuse. Many providers have adopted directive or first-line counseling approaches in which 
LARC is recommended above all others [50][51]. 
 
A.5. Tailored Patient Approaches are Needed to “Activate” Patients. Racial and ethnic minorities 
in general are less willing to participate in health care decision-making [52]. Latinos and African 
Americans report worse patient-provider relationships and communication [53]. These patients 
also receive less information regarding treatment and are less likely to be asked about their 
preferences [54]. Populations with low activation are likely to benefit from improved activation 
[55]. There is a need for interventions designed for the characteristics of the population (e.g., 
demographic, culture, literacy, age) [56]. 
 
A.6. Technological Interventions Can Support Health Care. Interactive, computer-based 
programs provide a novel platform for delivering health interventions [57]. Tailored, theory-
based interventions have been effective for assisting with smoking cessation [58], community 
counseling interventions for repeat births among low-income African American adolescent 
mothers [59], promoting adherence to antiretroviral medications [60], and increasing awareness 
of diabetes complications [61]. Touchscreen computer and tablet interventions have increased 
likelihood of choosing highly effective contraception [62, 63]. Young women are willing to 
receive sexual health information via digital media, perceiving these delivery routes as private 
and accessible [64, 65]. 
 
2.0 
Rationale and Specific Aims 
 
The proposed study seeks to evaluate a post-partum app.  Using a pre-post survey design the 
following hypotheses will be tested:  
 
H1: Do end users (pregnant women age 15-25) find the app usable, feasible, and acceptable 
and recommend continued development? 
H2: After using the app, users will have increased information about IPIs. 
H3: After using the app, users will have increased intention to communicate about IPIs with 
their provider. 
H4: After using the app, users will have increased Patient Activation Measures. 
 
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion criteria are: 
 
(1) Being 18-25 years old  
(2) Currently pregnant.   
 (3) Identify as African American/Black 
 
Exclusion criteria are: 

 
Being male 
Being over age 25.   
Not identifying as African American/Black 
 
The rationale for exclusion criteria is to focus on adolescent and young adult pregnancy and 
pregnancy prevention among this group.   
 
 
4.0 
Recruitment and Enrollment 
 
We will recruit up to 40 young pregnant women who are between 15-25 to evaluate our app.  
Participants will be paid $35 upon completion of study activities.  Participants will be recruited 
from ACCESS prenatal care or maternity community clinic waiting rooms. 
 
Prenatal case management teams will inform patients there is a research study they may be 
eligible for.  If potential participants are interested they will be told to contact a research team 
member in the waiting room.  Research team members will administer a short screener survey 
on an iPad to ensure eligibility.  The survey will inform potential participants if they are eligible 
or not.  If participants are eligible they will be taken through informed consent/assent. 
 
Additionally flyers will be posted directing interested potential participants to contact an ACCESS 
staff member or text a number (that will be a study phone, that is a Ci3 phone used only for 
study purposes) to enroll in the study.  ACCESS team members will refer potential participants 
to the research team member in the waiting room.  The same screener and informed 
consent/assent procedure will be performed.   
 
 
 
5.0 
Study Procedures 
 
Participants will be given a consent/assent form to read.  A researcher will ask the participant if 
they have any questions.  Once all questions have been resolved, or if there are no questions, 
the participant will sign the consent/assent form.  Consent/assent forms will be stored in a 
locked filing cabinet in a locked University of Chicago office. 
   
All participants will be given an iPad tablet containing a brief pre survey to fill out.  This survey 
will include questions on demographics, contraception knowledge, contraception use, and 
patient activation measures (readiness of patients to take charge of their own healthcare).  This 
survey will take 20-30 minutes to complete. 
 
Next participants will use the app on the iPad for 5-10 minutes.  Participants will be instructed 
to go through all parts of the app. 
 
Lastly, participants will complete a brief post survey on the iPad.  The survey will include 
questions on usability, feasibility, and acceptability of the app, patient activation measures, and 
contraception knowledge. This survey will take 20-30 minutes to complete. 
 

All study activities will take between 40-70 minutes to complete.  All study activities will take 
place in the waiting room. 
 
At the conclusion of the post surveys, participants will be paid and participation in the study will 
end.   
 
Participants will be paid $35 in visa gift card or cash equivalent after completion of the post 
survey.  
 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
Participants are exposed to few risks in this study. The informed consent/assent will assure 
participants complete confidentiality throughout the study.  Possible adverse events that are 
unanticipated will be brought to the attention of the Principal Investigators and Co-investigator, 
and reported immediately to the IRB. The IRB will determine whether it is appropriate to stop 
the study protocol temporarily or will provide suggestions/modifications to the study 
procedures. Possible modifications include adding these possible adverse events to the 
consent/assent form and re-consenting all study participants. The PI will be responsible for 
monitoring participant safety on a monthly basis at regularly scheduled research meetings. They 
will keep a written log of all adverse events and ensure that the IRB is contacted immediately. 
They will also keep a log of the outcome of IRB decisions regarding adverse events and apprise 
the research team of any changes that need to be made as a result of IRB decisions. If a 
participant discloses suicidal ideation, any type of violence, or homicidal intent, the Research 
Team will assess the level of risk and determine the best course of action (e.g., sending the 
participant to the emergency room, notifying the police). 
 
 
7.0 
Privacy/Confidentiality Issues 
Study records that identify the participant will be kept confidential.  All participants will be 
assigned a unique study identifier. Informed consents/assents with the subjects’ names will be 
stored at the UC and only accessible to designated research staff. Printed consent/assent forms 
will be stored in a locked filing cabinet in a locked University of Chicago office and they will only 
be available to the research team described in the proposal. All reports, manuscripts, and 
presentations will omit identifying information. Participants are informed of these protections in 
the consent/assent form.  
8.0 
Record Retention 
All data will be stored on a secure, password- protected computer or iPad tablet and printed 
consent/assent forms will be stored in a locked filing cabinet in a locked University of Chicago 
office. They will only be available to the research team. 
9.0 
Statistical Analysis Plan 
Descriptive statistics will be used to describe the study sample and the feasibility, usability, and 
acceptability of the app. Appropriate parametric and nonparametric paired statistics will be used 
for outcomes assessed at pre- and post-test based on data normality and how well assumptions 
are met.  

 
 
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