Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients

NCT ID: NCT05505435

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 653 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-04-30

Brief Summary

Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.

Conditions

Contraception

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DMPA-SC

self-administered subcutaneous depot medroxyprogesterone acetate 104 mg

Group Type: ACTIVE_COMPARATOR

Depot-Medroxyprogestereone Acetate

Intervention Type: DRUG

subcutaneous depot medroxyprogesterone acetate

DMPA-IM

provider-administered intramuscular depot medroxyprogesterone acetate 150 mg

Group Type: ACTIVE_COMPARATOR

Depot-Medroxyprogestereone Acetate

Intervention Type: DRUG

intramuscular depot medroxyprogesterone acetate

Interventions

Depot-Medroxyprogestereone Acetate

subcutaneous depot medroxyprogesterone acetate

Intervention Type: DRUG

Depot-Medroxyprogestereone Acetate

intramuscular depot medroxyprogesterone acetate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient planning DMPA for post-abortion contraception.

Exclusion Criteria

• Patient cannot speak and read English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Ashley Turner, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Family Planning Associates

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashley Turner, MD

Role: CONTACT

ashley.turner1@nm.org

312-926-8678

Facility Contacts

Erica Bishop, MD

Role: primary

erica.bishop@nm.org

717-799-3602

Other Identifiers

00216775

Identifier Type: -

Identifier Source: org_study_id