Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Complete Uterine Evacuation After Use of Study Drugs

Treatments: Drug: Mifepristone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01768299

1008

Details and patient eligibility

About

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.

Enrollment: 504 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Closed cervical os and no vaginal bleeding
• Live fetus at time of presentation for service
• No contraindications to medical abortion and study procedures, according to provider
• Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
• Willing to follow study procedures

Exclusion criteria

• Known previous transmural uterine incision
• > 5 parity
• Signs and symptoms of infection
• Any contraindications to vaginal delivery, including placenta previa
• Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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504 participants in 2 patient groups

Mifepristone at home 24 hours before miso dosing starts

Experimental group

Description:

All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.

Treatment:

Drug: Mifepristone

Mifepristone and first dose of misoprostol simultaneously.

Experimental group

Description:

Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled.

Treatment:

Drug: Misoprostol