ContraceptionNCT05285605
Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy
An observational study of Contraception and Contraceptive Usage, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Contraception, Contraceptive Usage, Reproductive Issues
- What is being tested?
- Ulipristal Acetate
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 22 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine Prentice Women's Hospital
Chicago, Illinois, 60611
About this study
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.
Read the 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.
- Conditions
- Contraception, Contraceptive Usage, Reproductive Issues
- Being tested
- Ulipristal Acetate
- Keywords
- Emergency Contraception, Reproductive Autonomy
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal AcetateDrug
Also called Ella
Ulipristal acetate 30mg x 1 dose as needed for unprotected intercourse
| Study group | Role | What they receive |
|---|---|---|
| Emergency Contraceptive Group | Group of participants receiving emergency contraception in the form of 3 packages of ulipristal acetate to use at home if needed. Receives: Drug: Ulipristal Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Knowledge is assessed at baseline, 6 weeks, 3 months, and 6 months
Number of participants who use emergency contraception during study period
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.
Measured: Throughout the study period, assessed at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Ashley M Turner, MD MSc, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285605
- Sponsor's protocol ID
- STU00215994
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy
- ClinicalTrials.gov ID
- NCT05285605
- Acronym / sponsor ID
- STU00215994
- Conditions
- Contraception, Contraceptive Usage, Reproductive Issues
- Keywords
- Emergency Contraception, Reproductive Autonomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Contraceptive Group | – | Drug: Ulipristal AcetateGroup of participants receiving emergency contraception in the form of 3 packages of ulipristal acetate to use at home if needed. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulipristal AcetateAlso: EllaUlipristal acetate 30mg x 1 dose as needed for unprotected intercourse | Drug | Emergency Contraceptive Group |
Primary outcome
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.
2 secondary outcomes
Change from baseline in knowledge around emergency contraception
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley M Turner, MD MSc principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Contraceptive Usage, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in reproductive autonomy (time frame: Reproductive autonomy will be assessed at baseline, 6 weeks, 3 months, and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.