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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Medical Abortion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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71-77 days of gestational age

Pregnant people whose pregnancies are estimated to have a gestational age of 71-77 days. (Participants in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range).

Group Type NO_INTERVENTION

No interventions assigned to this group

78-84 days of gestational age

Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days.

Group Type EXPERIMENTAL

Mifepristone + 2 doses of misoprostol 800 mcg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

11 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes