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Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients - Trial NCT05505435

Access comprehensive clinical trial information for NCT05505435 through Pure Global AI's free database. This Phase 4 trial is sponsored by Northwestern University and is currently Not yet recruiting. The study focuses on Contraception. Target enrollment is 653 participants.

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NCT05505435
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05505435
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Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients
Continuation Rates of Self-administered Subcutaneous Depot Medroxyprogesterone Acetate and Provider-administered Intramuscular Depot Medroxyprogesterone Acetate in Patients Seeking Post-abortion Contraception

Study Focus

Contraception

Depot-Medroxyprogestereone Acetate

Interventional

drug

Sponsor & Location

Northwestern University

Timeline & Enrollment

Phase 4

Aug 01, 2022

Oct 01, 2023

653 participants

Primary Outcome

DMPA continuation rate

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.

ICD-10 Classifications

Contraceptive management
Oral contraceptives
Other contraceptive management
General counselling and advice on contraception
Personal history of contraception

Data Source

ClinicalTrials.gov

NCT05505435

Non-Device Trial