A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

Gynuity Health Projects320 enrolled

Overview

The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

Legally Induced Abortion Without Mention of Complication

Interventions

MifepristoneDRUG

200mg oral mifepristone to both study arms

Buccal misoprostolDRUG

doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone

Sublingual misoprostolDRUG

doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Meet criteria to obtain abortion * Present with closed cervical os and no vaginal bleeding * Live fetus at time of presentation for service * Have no contraindications to study procedures, according to provider * Be able to consent to procedure, either by reading consent document or by having consent document read to her * Be willing to follow study procedures Exclusion Criteria: * Known previous transmural uterine incision * Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol * Any contraindications to vaginal delivery * Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Locations (4)

b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)

Yerevan, Armenia

RECRUITING

Kathmandu Medical College

Kathmandu, Nepal

RECRUITING

La Rabta Maternity Hospital

Tunis, Tunisia

RECRUITING

Outcomes

Primary Outcomes

Rate of successful abortion by 24 hours

Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.

Time frame: 24 hours following the start of misoprostol

Rate of successful abortion by 48 hours

Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.

Time frame: 48hours following the start of misoprostol

Secondary Outcomes

Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).

Time frame: 48 hours

Percentage of patients requiring provision of additional interventions.

Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours

Total number of doses of misoprostol.

Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours

Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment

Time frame: 1 month

Pain scale (1-7) as reported by women on questionnaire

Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours

Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire

Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.