Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
Study NCT ID:
NCT05285605
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2022-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: