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

Medical Abortion Clinical Trial

Official title:

An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05119439
• Other study ID #: 1050
• Status: Terminated
• Phase: Phase 4
• Start date: October 7, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Drug:
• Mifepristone + 2 doses of misoprostol 800 mcg
Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants.

Locations

Country	Name	City	State
United States	Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky	Federal Way	Washington
United States	University of Hawaii	Hilo	Hawaii
United States	University of Hawaii	Honolulu	Hawaii
United States	Philadelphia Women's Center	Philadelphia	Pennsylvania
United States	Planned Parenthood North Central States	Saint Paul	Minnesota
United States	Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason	Proportion of women who achieve complete abortion with medication only and without aspiration or D&E	7-36 days after initial visit
Secondary	Proportion of participants who report each individual side effect	Side effects include diarrhea, nausea, vomiting, fever, chills	7-14 days after initial visit
Secondary	Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization	Complications could include abnormal bleeding, severe pain, retained tissue	7-14 days after initial visit
Secondary	Proportion of participants who determine method acceptable	Overall acceptability, time to complete abortion, bleeding, side effects, pain	7-36 days after initial visit