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

Gynuity Health Projects504 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

504

Conditions

Complete Uterine Evacuation After Use of Study Drugs

Interventions

MifepristoneDRUG

200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol

MisoprostolDRUG

200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (3)

Binh duong Obstetrics and Newborn Hospital

Ho Chi Minh City, Binh Duong Province, Vietnam

National Ob-Gyn Hospital

Hanoi, Vietnam

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.

Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.

Time frame: Within 1 week

Secondary Outcomes

Induction to abortion interval

Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.

Time frame: Within 1 week

Women's acceptability of the assigned method.

Time frame: Within 1 week

Rate of fetal expulsion

Defined as fetal expulsion with study drug alone.

Time frame: Within 1 week

Provision of additional interventions

For example: Uterine massage, Manual removal, Sponge forceps, D\&C or D\&E, Repeat medical abortion drugs

Time frame: Within 1 week

Time interval from the mifepristone dose to abortion

Defined as length of time from initiation of mifepristone to complete abortion achieved.

Time frame: Within 1 week

Total dose of misoprostol administered

Time frame: Within 1 week

Data from ClinicalTrials.gov

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