Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure

Phase 4

Completed

• Conditions: Abortion, Missed
• Interventions: Drug: Misoprostol

• Registration Number: NCT02515604
• Lead Sponsor: Wolfson Medical Center

Brief Summary

A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-02
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
• Age equal or greater than 18 years
• Gestational age less than 12 complete weeks.

Exclusion Criteria

• Complete, incomplete, inevitable, or septic abortion.
• Hemodynamically unstable patients.
• Misoprostol sensitivity or contraindication.
• Multifetal pregnancies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single dose group	Misoprostol	-
Repeated dose group	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)	Day 8 from first misoprostol dose	Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 Holon, Israel