Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy
Conditions: Contraception, Contraceptive Usage, Reproductive Issues
Sponsor: Northwestern University

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PROTOCOL TITLE: Advance provision of postpartum emergency contraception and its 
effects on reproductive autonomy: a mixed methods study 
 
PRINCIPAL INVESTIGATOR: 
Ashley Turner 
Department of Obstetrics & Gynecology  
Ashley.turner1@nm.org 
(231)-620-0549 
 
VERSION DATE: 10/3/21 
  
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
Ulipristal acetate (UPA)  
IND / IDE / HDE #  N/A 
Indicate 
Special Population(s) 
Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size 75 
Funding Source Society of Family Planning, Emerging Scholars 
Grant 
Indicate the type of 
consent to be obtained 
Written  
Verbal/Waiver of Documentation of Informed 
Consent 
Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
Northwestern Medicine Prentice Women’s 
Hospital 
Research Related 
Radiation Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
OBJECTIVES: 
1. Understand the effects of advance provision of emergency contraception (EC) on 
factors beyond unintended pregnancy, in particular reproductive autonomy 
2. Explore patient preferences in the postpartum period around contraceptive use 
3. Assess use of EC in the postpartum period and the context that surrounds its use 
4. Provide a patient-centered-and-controlled intervention to those who desire EC in 
the postpartum setting that facilitates contraceptive choice and access. 

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Hypothesis:  
We hypothesize that providing an advance supply of EC will increase use and decrease 
barriers to use. Additionally, we hypothesize that, with thorough EC counseling, 
participants will develop an increased knowledge base of EC. With increased use and 
knowledge, we hypothesize that participants will experience greater reproductive 
autonomy over their contraceptive decisions.  
 
BACKGROUND: 
Emergency contraception (EC), an alternative or supplemental method that can be used 
in the event of having unprotected sexual intercourse, can offer people increased 
reproductive choice and freedom. Multiple pharmacologic options for EC now exist, with 
two available oral pills: levonorgestrel (LNG) and ulipristal acetate (UPA).1 While the 
primary mechanism of both pills is to delay or inhibit ovulation, UPA has been shown to 
be more effective than LNG. Importantly, it can be used for up to 120 hours after 
unprotected intercourse compared to 72 hours for LNG. Though EC is overall less 
effective in overweight and obese patients, UPA still is more effective in these patients 
compared to LNG.2-3 To increase access to EC, in August 2013, the FDA ultimately 
approved the LNG pill to be provided over the counter without any age restrictions, but 
barriers to access still exist, such as unavailability, pharmacist resistance, and lack of 
knowledge within both patients and providers.4 Accessing UPA is even more difficult as 
it still requires a prescription, and many pharmacies in the United States do not have 
UPA readily in stock.5 Ensuring access to EC is a fundamental component of 
comprehensive contraceptive counseling and reproductive healthcare. Thus, strategies 
to increase access were introduced, including advance provision of EC, and it was 
hypothesized that increased access to EC would thereby decrease unintended 
pregnancy rates.6  
 
Almost half of pregnancies in the United States are unintended, though this rate is 
declining.7 As a national public health issue, unintended pregnancy is associated with 
increased economic and emotional burden on mothers and families and impact our 
most marginalized communities.8 However, some scholars have criticized using 
unintended pregnancy as a measure for several reasons. The intendedness of a 
pregnancy is not always clear, and many people hold ambivalence over their pregnancy 
desires. Moreover, unintended pregnancies are not always adverse outcomes. 
Importantly, data showing higher rates of unintended pregnancy amongst marginalized 
communities can lead to further stigmatization, targeted and perhaps coercive 
contraceptive tactics, and shift of blame from structural inequalities to individual 
failures.9-11  
 
Ultimately, the effect of advance provision of EC on unintended pregnancy has had 
disappointing results. Multiple randomized controlled trials have overwhelmingly found 
no change in unintended pregnancy rates with advance provision of EC,12-13 with a few 
exceptions.14-15 In response, some proponents of EC have called for research efforts to 
be shifted towards effective strategies in decreasing unintended pregnancy, such as 
increasing the uptake of long-acting reversible contraception (LARC).16-18 However, 
given that rates of unintended pregnancy are highest amongst poor, black, Latinx, 

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young people, many reproductive justice scholars have thoughtfully raised concerns 
over the fine balance between contraceptive access and coercion.19-23 Studies have 
reinforced the reality of reproductive injustice in this country, with providers changing 
their counseling based on race and ethnicity and patients of color feeling the pressure of 
contraceptive coercion.22-23 For many of the marginalized people that have lived 
through, directly or indirectly, the efforts to control their reproductive autonomy, LARCs 
may not represent the beacon of reproductive freedom that they are for others. Often, 
members of these marginalized communities prefer and choose methods where they 
are fully in control and are able to start, continue, and discontinue as they desire.24-25 
 
Our project hopes to add depth to the literature through evaluating EC from a justice-
focused framework. While having the capability of planning one’s pregnancy can 
certainly be empowering, in what other ways can advance provision of EC further 
promote reproductive freedom and autonomy beyond the intendedness of a pregnancy? 
Studies have shown that advance provision of EC leads to increased and faster use, 
high acceptability and satisfaction, and increased knowledge of EC and other 
contraceptive methods.6, 12-13 Furthermore, providing EC prior to the “emergency” also 
allows for opportunities for healthcare providers to counsel on contraceptive use and 
sexually transmitted infections (STIs).12 This study aims to use quantitative and 
qualitative methods to explore the effects of advance provision of EC on reproductive 
autonomy. However, our project will first focus our study population on postpartum 
patients, for the following reasons. First, few studies on advance provision of EC focus 
on the postpartum patient, though the antepartum and postpartum period is a rich 
opportunity for contraceptive counseling given increased motivation to prevent 
pregnancy and access to consistent reproductive healthcare.26 Additionally, the risk of 
having another pregnancy is even more stark for these patients.  Having a short 
interpregnancy interval, defined as less than 18 months from delivery to subsequent 
conception, is notably associated with increased maternal and fetal risk, including low 
fetal birth weight and preeclampsia. Out of all pregnancies, 35% occurred within 18 
months of their prior birth, and 55% of these pregnancies were unintended.27 Studying 
the impact of EC within this population can have important health effects on our patients 
and their families, while offering an opportunity to provide an empowering intervention.  
 
In the face of increased access to EC on a legislative level, EC still remains 
underutilized, with multiple research studies showing its ineffectuality in successfully 
decreasing rates of unintended pregnancy. Using reproductive justice as our framework, 
our study hopes to provide an intervention to our patients who desire increased 
contraceptive choice, highlight the potential benefits of EC in promoting reproductive 
autonomy and freedom in a population highly motivated to prevent pregnancy, and add 
to the current body of literature on EC.   
 
 
STUDY INTERVENTION(S) / INVESTIGATIONAL AGENT(S): 
Study intervention: Provide advance supply of UPA (3 doses) prior to discharge from 
hospital after delivery. UPA is currently available through prescription and is FDA 
approved for emergency contraception. Therefore, it is not an investigational new drug 

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or device. Participants will have a prescription sent to the pharmacy. The pharmacy will 
fill this prescription for the patient, which will be delivered to the patient prior to 
discharge.     
 
STUDY ENDPOINTS 
(1) Collection and analysis of EC use and knowledge via surveys 
(2) Collection and summarization of narrative verbatim transcripts of interviews 
 
PROCEDURES INVOLVED / METHODS: 
This project will be a prospective observational study, using a mixed-methods design to 
further explore the impact of EC use on postpartum patients’ feelings of reproductive 
autonomy. We will aim to recruit 75 participants, with an expected 40-50 participants 
retained at 6 months, and 15-20 of those participants choosing to participate in an in-
depth interview at 6 months. Participants will first be screened for eligibility on chart 
review. If any inclusion/exclusion criteria remain unclear in the medical record, these 
participants will still be approached to complete the eligibility survey if they are 
interested in participating in the study. All potential participants will confirm their 
contraceptive method prior to enrolling in the study. Participants who are undecided on 
their postpartum contraceptive plan will not meet inclusion criteria for the study. This is 
to avoid possible coercion or influence by the research study on patients’ contraceptive 
choices.  
 
If they choose to enroll in the study, they will undergo an informed consent and a 
baseline survey comprised of standard demographic questions, questions on 
reproductive and contraceptive history, knowledge on EC, and questions on 
reproductive autonomy. The section on reproductive autonomy is adapted from the 
Reproductive Autonomy Scale.28 This survey will be designed to take ~10 minutes to 
complete. Participants will undergo standardized counseling on postpartum 
contraception. This counseling will include 1) best-practice recommendation for high-
efficacy postpartum contraception, 2) recommendation for appropriate pregnancy 
spacing, 3) efficacy of contraceptive methods, and 4) types of EC and detailed 
instructions for use. They will receive a package of three doses of UPA prior to being 
discharged home along with educational material for EC. If participants need additional 
doses of EC, they would be able to call the clinic for additional doses. Participants will 
then complete surveys at 6 weeks, 3 months, and 6 months. In the 6-week survey, if 
they have used EC by that time, they will be invited to participate in a brief, 20-30 
minute interview that will focus on their experience, comfort, and facilitators/barriers to 
their most recent EC use. In the 6-month survey, the participant will be invited to 
participate in an in-depth interview designed to further explore participant experiences 
with EC. The qualitative interview is expected to last ~1 hour and will discuss themes 
around EC use, acceptability, autonomy, contraceptive choice.  
 
As the study intervention uses a drug that is FDA-approved for emergency 
contraception, participants are not expected to undergo additional risk with this 
intervention. The electronic medical record will be used to conduct a preliminary chart 

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review on possible eligible patients prior to approaching them for recruitment. The 
survey instrument and interview scripts are attached to this document.  
 
This study will collect data from the surveys and the interviews. The surveys will be 
completed online, in person, or via the phone based on participant preference. The 
interviews will be in person and will be audio-recorded. Audio-recording of the 
interviews is necessary for this research in order to transcribe verbatim for data 
analysis. The audio recordings will only be used for data analysis and will be stored in a 
password-protected folder within the Northwestern Medicine secure departmental 
server. The password will only be available to the study team. Once the audio 
recordings are transcribed verbatim, they will be destroyed immediately.  
 
STUDY TIMELINES 
Participants will be recruited into the study on postpartum day #1. Then, they will 
complete surveys at 6 weeks, 3 months, and 6 months. At the 6 month survey, they will 
be invited to participate in an in-depth interview that would be scheduled within the 
following month. Therefore, the total duration of an individual’s participation in the study 
would be 7-8 months, if they were to complete the study.  
 
The investigators will be recruiting patients concurrently with primary data collection. We 
expect participant enrollment to occur from December 2021 – May 2022 (6 months). We 
expect primary data analyses to be completed by September 2022.  
 
INCLUSION AND EXCLUSION CRITERIA 
Participants will first be screened for eligibility through a chart review. Then upon first 
assessment on postpartum day #1, participants will complete a survey to confirm 
eligibility. If any of the inclusion or exclusion criteria are unclear on chart review, these 
participants will still be approached to complete the eligibility survey if they are 
interested in participating in the study. 
 
Inclusion criteria:  
- 16-40 years of age 
- English-speaking 
- In a sexual relationship with possibility of pregnancy 
- Delivered a live infant 
- Desire to delay pregnancy for at least a year 
- A patient at Northwestern University Feinberg School of Medicine Department of 
Obstetrics and Gynecology 
- Choosing no postpartum contraceptive method or a lower efficacy method: condoms, 
female condoms, diaphragm/cervical cap/sponge, fertility awareness method 
 
Exclusion criteria:  
- Allergy to UPA 
- Those who have had tubal sterilization 
- Those who conceived via assisted reproductive technology 
- Those with inability to follow up 

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- Those taking drugs that interact with UPA (CYP3A4 inducers, abametapir, felbamate, 
fexinidazole, fusidic acid, griseofulvin, oxcarbazepine, progestins, topiramate) 
 
Special populations  
Excluded: adults unable to consent, currently pregnant women, prisoners 
Included: Individuals who are not yet adults (teenagers between the age of 16-17).  
 
Rationale: This study requires informed consent to participate, so adults without the 
ability to consent will not be approached for this study. This study aims to provide 
emergency contraception to postpartum patients, so currently pregnant women will not 
be approached. Incarcerated people do not receive obstetric care at Prentice Women’s 
Hospital, so they will not be approached for the study.  
 
This study does include individuals who are not yet adults (teenagers who are 16 and 
17 years old). However, given that these individuals will all have delivered a liveborn 
infant, they do not require parental permission to participate in the study, and they are 
able to consent to the study. Additionally, individuals who are under the age of 18 are 
allowed to consent to any and all contraceptive methods, including EC, without parental 
consent.  
 
RECRUITMENT METHODS 
Participants will be patients of Northwestern University Feinberg School of Medicine 
Department of Obstetrics and Gynecology. This includes the following clinics: 
Northwestern Medicine Faculty Foundation, Prentice Ambulatory Care, Maternal Fetal 
Medicine. These patients will be identified while on Labor and Delivery, prior to delivery. 
Potential participants will first be screened with a chart review. Patient without clear 
documentation on their postpartum birth control method will be included in possible 
recruitment.  
 
Potential participants will be recruited on postpartum day #1 on the inpatient postpartum 
floors in Prentice Women’s Hospital. On postpartum day #1, they will undergo eligibility 
confirmation, informed consent, baseline survey administration, contraceptive 
counseling, and review of study logistics, including compensation. This visit duration will 
be around 30 minutes. As these patients will be approached while they are inpatient, 
they will not be compensated for completing this visit. Potential participants will be 
screened and recruited while they are inpatient, and there will not be additional 
recruitment materials, such as posters or flyers.  
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
Visit 
Type of activity 
Compensation 
#1 (6 weeks) 
10-minute survey 
 
$10 
 
Possible brief 20-minute interview 
$20  
#2 (3 months) 10-minute survey 
$10  

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#3 (6 months) 10-minute survey 
 
$10  
Possible 1-hour in-depth interview 
$50 
 
Participants will be compensated with Stored Value (VISA) cards. This card will be 
given to each participant upon joining the study on postpartum day 1. Compensation will 
be loaded onto the card upon completion of each study activity. Total possible 
compensation from this study, if the participant were to complete all components, would 
be $100. In addition, if in-depth interviews are conducted in-person, compensation 
would be provided for transportation costs. A discounted research parking pass (valued 
at $7 each) would be provided to those who are driving, and anyone taking public 
transportation or rideshare would be reimbursed on their Stored Value Card.  
 
Participants will also be informed of any results of this study via their email.  
 
 
 
WITHDRAWAL OF PARTICIPANTS 
Any participant may be withdrawn from the study if the subject or the Investigator feels 
that it is not in the participant’s best interest to continue. Participants may withdraw from 
the study at any time without penalization. Possible reasons for withdrawal include: 
subject withdrawal of consent, pregnancy, adverse event that would preclude continued 
participation in the intervention, inability to follow up/lost to follow up. To prevent undue 
pressure on contraceptive choice, participants will not be withdrawn if they were to 
choose or change their contraceptive methods, even if the method were to be a higher-
efficacy option, such as an intrauterine device.  
 
RISKS TO PARTICIPANTS 
Physical risks of this study include possible adverse effects of taking ulipristal acetate, 
such as gastrointestinal symptoms (nausea, abdominal pain) or alterations to the 
menstrual cycle. This risk is minimized through excluding patients with an allergy to 
ulipristal acetate and thoroughly counseling patients on the medication and its side 
effects. Patients will additionally be able to contact their respective clinics through 
telephone, MyChart, or in-person visit, if they are concerned about any side effect. This 
is overall a reasonable risk to undertake, as UPA is an FDA approved medication for 
emergency contraception, and individuals are able to take this medication for this 
indication outside of this study. Psychological risks include potential discomfort or 
embarrassment with answering questions related to sexual activity and reproductive 
healthcare. This risk is minimized through providing an open and nonjudgmental 
environment and allowing participants to decline or refuse any question they are 
uncomfortable with answering. An additional psychological risk is the possibility of 
pregnancy even with taking emergency contraception, which may be more unexpected 
for the patient if they are undergoing this study. This risk will be minimized through clear 
counseling around EC and the risks of failure even with correct usage.  
 
POTENTIAL BENEFITS TO PARTICIPANTS 

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For participants, a potential benefit is having a form of emergency contraception 
immediately available to them if it were necessary. Participating in this study may 
provide them with a feeling of increased control or autonomy over their reproductive 
decisions. Undergoing thorough counseling on emergency contraception may benefit 
participants through increasing their knowledge and awareness around emergency 
contraception.  
 
DATA MANAGEMENT AND CONFIDENTIALITY 
As a mixed-methods study, the target enrollment number of 75 participants is centered 
around adequate data saturation for a qualitative analysis. With 75 participants initially 
enrolled, it is expected that 45-60 participants will be retained at 6 months, with 15-20 
participants choosing to participate in an in-depth interview. Fifteen to twenty, 1 hour, 
interviews will very likely yield sufficient data saturation for our qualitative analysis. For 
our quantitative analysis, our project will analyze EC use amongst our study population. 
We will also compare EC knowledge scores within each individual participant between 
their baseline survey and their 6-month survey.  
Multiple steps will be taken to ensure data security. First, survey and interview data will 
be deidentified and will not include PHI. Participants will have a unique identification 
code assigned to them during the screening process. Participant names will only be 
recorded on Informed Consent Forms (inclusive of HIPAA authorization) and a master 
document that links identification codes with the participant, along with their contact 
information. Only designated study staff will have access to this master document. Any 
identifying information noted in the interview data will be substituted by their 
identification code or an appropriate label. 
 
All documents will be both password-protected and stored only on the Northwestern 
Medicine departmental secure server. All audio files will be deleted immediately upon 
transcription. Passwords will only be shared with the study team, which will be 
composed of only individuals included on the IRB protocol who have undergone the 
required training. Once a participant has completed their research activities and the 
study is complete, all locator information will be destroyed, unless they wish to be 
contacted for, or be referred to, other studies conducted by the investigators or their 
colleagues.  
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
Participants will only interact with members of the study team who have been 
appropriately recruited and trained for this study protocol. Additionally, the interviews 
will solely be conducted by the Investigator. In order to ensure maximum participant 
comfort with potentially uncomfortable questions and topics, participants will be 
informed that sensitive questions are optional, and they can decline to answer these 
questions. This will be emphasized at the beginning of every survey and interview. 
Additionally, participants are allowed to end a survey or interview early, if they feel the 
need to. Interviews will be conducted in a quiet, private space with only the interviewer 
and participant present. If participants are uncomfortable with any of the study team 
members, this concern will be seriously assessed, and participants may choose to not 
interact with certain team members. Members of the study team have access to all of 

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the research documents, and reviewing participants’ medical records will be a 
necessary component of this study. However, study team members will only access 
information relevant to the study.  
 
ECONOMIC BURDEN TO PARTICIPANTS 
Potential economic burden is mitigated by participant compensation detailed above. 
 
CONSENT PROCESS 
Research staff responsible for providing informed consent will review study procedures, 
risks and benefits, as well as important study procedures and aspects of consent (i.e. 
voluntary nature of participation, confidentiality, right to withdraw, risks and benefits of 
participation, study procedures, etc.) with potential participants, and answer any 
questions they may have. Consent will take place in their private inpatient room on the 
postpartum floor, with care to minimize distractions as much as possible. The 
participants will be reassured that the information to be collected is solely for research 
purposes and will remain confidential to the research project personnel. They will be 
informed that they will be compensated for their time and effort at the rates specified in 
the consent. The participants will be informed of their right to refuse to answer any 
questions and their right to withdraw from the study at any time. Potential participants 
will be explicitly asked if they have any questions or need any component of the consent 
form to be repeated. Immediately after informing the participant, they will be asked to 
sign, initial, and date the informed consent form. The consent form will be co-signed and 
dated by the research staff in the presence of the participant. Duration of consent 
procedure will likely differ based on each individual participant, but average time 
devoted to the consent discussion should be 8-10 minutes.  
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
This study will involve the use of Protected Personal Health Information. A HIPAA 
authorization will be obtained from all of the participants.  
 
The following PHI will be used: name, date of birth, telephone number, medical record 
number, chart review 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
This study is supported by a number of resources that promotes the feasibility of 
completing this project. First, Northwestern Medicine Prentice Women’s Hospital is a 
highly regarded, large-volume obstetric center in Illinois. With over 13,000 deliveries 
every year, this hospital is an optimal location to conduct research on postpartum and 
reproductive health. It is estimated that the clinics included in our recruitment comprise 
~3,000 of those deliveries. Studies have shown that ~40-50% of postpartum patients 
choose no method or low efficacy methods after delivery.30 Given our plan for 
recruitment over 6 months, we would have access to ~750 possible participants. We 
would therefore need to recruit 10% of these potential participants to meet our goal of 
75 participants, which appears feasible.  
 

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In order to conduct and complete this research, I will be devoting ~10 hours weekly on 
this study. In addition, members of the study team will be recruited with clear 
expectations on time commitment. A full-time, paid research assistant, who is employed 
through Northwestern Medicine Faculty Foundation, will also be able to contribute to the 
study, especially during the recruitment process.  
 
The facilities at Northwestern Medicine will be sufficient for the purposes of this study. 
The inpatient rooms allow for privacy to conduct the initial screening and baseline 
surveys. For any further in-person study activities, such as interviews, a private room in 
the same location as the OBGYN clinics can be reserved. Participants will remain as 
patients of their respective clinics during this study; if participants experience any 
adverse effects from the intervention, they will have access to the same clinical staff as 
prior to enrolling in this study.  
All members of the study team will be fully trained on all aspects of the protocol and 
research procedures prior to starting their roles. In order to ensure this, I will conduct 
meetings with each individual team member to review the protocol, their role, 
associated duties and tasks. 
References: 
1.     Shen, J., Che, Y., Showell, E., Chen, K., & Cheng, L. (2017). Interventions for 
emergency contraception. Cochrane Database of Systematic Reviews, (8). 
2.     Glasier, A. F., Cameron, S. T., Fine, P. M., Logan, S. J., Casale, W., Van Horn, J., 
... & Gainer, E. (2010). Ulipristal acetate versus levonorgestrel for emergency 
contraception: a randomised non-inferiority trial and meta-analysis. The Lancet, 
375(9714), 555-562. 
3.     Glasier, A., Cameron, S. T., Blithe, D., Scherrer, B., Mathe, H., Levy, D., ... & 
Ulmann, A. (2011). Can we identify women at risk of pregnancy despite using 
emergency contraception? Data from randomized trials of ulipristal acetate and 
levonorgestrel. Contraception, 84(4), 363-367. 
4.     Haeger, K. O., Lamme, J., & Cleland, K. (2018). State of emergency contraception 
in the US, 2018. Contraception and reproductive medicine, 3(1), 1-12. 
5.     Shigesato, M., Elia, J., Tschann, M., Bullock, H., Hurwitz, E., Wu, Y. Y., & Salcedo, 
J. (2018). Pharmacy access to Ulipristal acetate in major cities throughout the United 
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6.     Polis, C. B., Grimes, D. A., Schaffer, K., Blanchard, K., Glasier, A., & Harper, C. 
(2007). Advance provision of emergency contraception for pregnancy prevention. 
Cochrane Database of Systematic Reviews, (2). 
7.     Finer, L. B., & Zolna, M. R. (2016). Declines in unintended pregnancy in the United 
States, 2008–2011. New England journal of medicine, 374(9), 843-852. 
8.     Finer, L. B., & Zolna, M. R. (2016). Declines in unintended pregnancy in the United 
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9.     Potter, J. E., Stevenson, A. J., Coleman-Minahan, K., Hopkins, K., White, K., 
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10.  Gomez, A. M., & Wapman, M. (2017). Under (implicit) pressure: young Black and 
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