Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy

April 23, 2025 updated by: Northwestern University
This study will entail provision of ulipristal acetate (UPA) for emergency contraception (EC) in the postpartum period for patients who have not chosen to initiate a highly effective form of contraception and study the use of EC overall as well as with regards to participants' perception of reproductive autonomy. The investigators hypothesize that providing an advance supply of EC will increase use and decrease barriers to use. Additionally, the investigators hypothesize that, with thorough EC counseling, participants will develop an increased knowledge base of EC. With increased use and knowledge, the investigators hypothesize that participants will experience greater reproductive autonomy over their contraceptive decisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project will be a prospective observational study, using a mixed-methods design to further explore the impact of emergency contraception (EC) use on postpartum patients' feelings of reproductive autonomy. The investigators 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. 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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine Prentice Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants recruited for this study originate from a diverse group of obstetrics clinics, including a resident-run clinic, an academic faculty low-risk obstetric clinic, an academic high-risk obstetric clinic, and a high-risk fellow-run clinic. The majority of these participants are residents of Chicago and its metro area. These clinics see patients with public and private insurances, and the population is expected to be similarly diverse to the city of Chicago.

Description

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
  • Those taking drugs that interact with UPA (CYP3A4 inducers, abametapir, felbamate, fexinidazole, fusidic acid, griseofulvin, oxcarbazepine, progestins, topiramate)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency Contraceptive Group
Group of participants receiving emergency contraception in the form of 3 packages of ulipristal acetate to use at home if needed.
Drug: Ulipristal Acetate
Ulipristal acetate 30mg x 1 dose as needed for unprotected intercourse
Other Names:
  • Ella

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in reproductive autonomy
Time Frame: Reproductive autonomy will be assessed at baseline, 6 weeks, 3 months, and 6 months.
Uses a modified reproductive autonomy scale to measure participants' sense of reproductive autonomy. Highest score is 40 which is associated with greater reproductive autonomy and lowest score is 0.
Reproductive autonomy will be assessed at baseline, 6 weeks, 3 months, and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in knowledge around emergency contraception
Time Frame: Knowledge is assessed at baseline, 6 weeks, 3 months, and 6 months
Uses a survey that measures knowledge on emergency contraception. Highest score is 18 and lowest score is 0. Higher scores are associated with increased knowledge on emergency contraception
Knowledge is assessed at baseline, 6 weeks, 3 months, and 6 months
Number of participants who use emergency contraception during study period
Time Frame: Throughout the study period, assessed at 6 months.
Follow up surveys will ask participants if they have used emergency contraception and how many times. This will be compared with the total number of study participants in the study to denote the percentage of participants who used emergency contraception.
Throughout the study period, assessed at 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Ashley M Turner, MD MSc, Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

January 22, 2024

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00215994

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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