Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation

Phase 4

Completed

• Conditions: Medical Abortion
• Interventions: Drug: Mifepristone followed by misoprostol 24-48 hours later

• Registration Number: NCT02314754
• Lead Sponsor: Gynuity Health Projects

Brief Summary

To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 719

Inclusion Criteria

• intrauterine pregnancy between 64 days and 77 days' LMP
• eligible for medical abortion according to study doctor assessment
• willing and able to sign consent form
• speak english or spanish (in US sites); speak the local language(s) (in international sites)
• agree to comply with the study procedures and visit schedule

Exclusion Criteria

• Have known allergies or present other contraindications to mifepristone or misoprostol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
71-77 days gestational age	Mifepristone followed by misoprostol 24-48 hours later	Women whose pregnancies are estimated to have a gestational age of 71-77 days.

Primary Outcome Measures

Name	Time	Method
Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason	7-36 days	Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D\&C) for any reason

Secondary Outcome Measures

Name	Time	Method
Proportion of Providers Who Determine Method Acceptable	7-36 days	As assessed by service provider semi-structured interviews
Proportion of Women Who Determine Method Acceptable	7-14 days	overall acceptability, time to complete abortion, bleeding, side effects, pain
Proportion of Individual Side Effects Experienced by Participants	7-14 days	Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants

Trial Locations

Locations (8)

Clínica Comunitaria Santa Catarina; 🇲🇽 Mexico City, Mexico

Atlanta Women's Center; 🇺🇸 Atlanta, Georgia, United States

Family Planning Associates Medical Group; 🇺🇸 Chicago, Illinois, United States

John H. Stroger, Jr. Hospital of Cook CountY; 🇺🇸 Chicago, Illinois, United States

Scientific Research Institute of Obstetrics and Gynecology; 🇦🇿 Baku, Azerbaijan

Hung Vuong Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

David Gagua Clinic; 🇬🇪 Tbilisi, Georgia

Hartford GYN Center; 🇺🇸 Hartford, Connecticut, United States