Outpatient Service for Mid-trimester Termination of Pregnancy

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Abortion in Second Trimester

Treatments: Drug: Mifepristone + Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03346629

1039

Details and patient eligibility

About

This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.

Enrollment: 230 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have an ongoing pregnancy of 13-18 weeks gestation
• Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
• Has access to a phone where she can be reached at the 2-week follow-up
• Be willing to follow study procedures

Exclusion criteria

• Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
• Any contraindications to vaginal delivery
• More than one prior cesarean delivery
• Living more than 2 hours away from the hospital

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Mifepristone + Misoprostol

Experimental group

Description:

Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)

Treatment:

Drug: Mifepristone + Misoprostol