Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborator: Society of Family Planning
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• Seeking medical abortion services at one of the enrolling clinics

• Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days

• Meet standard eligibility criteria for medical abortion

• Be able to return to clinic for in-person follow up

• Speak/read/write English or Spanish

• Have access to a mobile phone with texting capability

• Be in general good health

• Be willing and able to sign consent forms

• Agree to comply with the study procedures and follow up.

Exclusion Criteria:

• Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.)

• With known allergies or other contraindications to mifepristone or misoprostol

• Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.