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

Phase 4

Terminated

• Conditions: Medical Abortion
• Interventions: Drug: Mifepristone + 2 doses of misoprostol 800 mcg

• Registration Number: NCT05119439
• Lead Sponsor: Gynuity Health Projects

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-15
• Study Start: 2022-10-07
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-23
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
78-84 days of gestational age	Mifepristone + 2 doses of misoprostol 800 mcg	Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days.

Primary Outcome Measures

Name	Time	Method
Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason	7-36 days after initial visit	Proportion of women who achieve complete abortion with medication only and without aspiration or D\&E

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who report each individual side effect	7-14 days after initial visit	Side effects include diarrhea, nausea, vomiting, fever, chills
Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization	7-14 days after initial visit	Complications could include abnormal bleeding, severe pain, retained tissue
Proportion of participants who determine method acceptable	7-36 days after initial visit	Overall acceptability, time to complete abortion, bleeding, side effects, pain

Trial Locations

Locations (4)

Planned Parenthood North Central States; 🇺🇸 Saint Paul, Minnesota, United States

Philadelphia Women's Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Hawaii; 🇺🇸 Honolulu, Hawaii, United States

Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky; 🇺🇸 Tacoma, Washington, United States