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

Gynuity Health Projects

Status and phase: Terminated; Phase 4

Conditions: Medical Abortion

Treatments: Drug: Mifepristone + 2 doses of misoprostol 800 mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT05119439

1050

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Female

Ages: 11 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

71-77 days of gestational age

No Intervention group

Description:

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).

78-84 days of gestational age

Experimental group

Description:

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

Treatment:

Drug: Mifepristone + 2 doses of misoprostol 800 mcg