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

Phase 4TerminatedNCT05119439

Gynuity Health Projects23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Medical Abortion

Interventions

Mifepristone + 2 doses of misoprostol 800 mcgDRUG

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.

Eligibility

Sex: FEMALEMin age: 11 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

University of Hawaii

Hilo, Hawaii, United States

University of Hawaii

Honolulu, Hawaii, United States

Planned Parenthood North Central States

Saint Paul, Minnesota, United States

Philadelphia Women's Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 7-36 days after initial visit

Secondary Outcomes

Proportion of participants who report each individual side effect

Side effects include diarrhea, nausea, vomiting, fever, chills

Time frame: 7-14 days after initial visit

Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization

Complications could include abnormal bleeding, severe pain, retained tissue

Time frame: 7-14 days after initial visit

Proportion of participants who determine method acceptable

Overall acceptability, time to complete abortion, bleeding, side effects, pain

Time frame: 7-36 days after initial visit

Data from ClinicalTrials.gov

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