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

NCT05285605 | Completed DMC FDA Drug

• 1 other identifier: STU00215994
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contraception; Contraceptive Usage; Reproductive Issues

Keywords

Emergency Contraception; Reproductive Autonomy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in reproductive autonomy

  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 Outcomes (2)

• Change from baseline in knowledge around emergency contraception

  Knowledge is assessed at baseline, 6 weeks, 3 months, and 6 months

• Number of participants who use emergency contraception during study period

  Throughout the study period, assessed at 6 months.

Study Arms (1)

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

Interventions

Ulipristal Acetate DRUG

Ulipristal acetate 30mg x 1 dose as needed for unprotected intercourse

Also known as: Ella

Emergency Contraceptive Group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Ashley M Turner, MD MSc

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 17, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: January 22, 2024
• Last Updated: April 27, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)