Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Phase 2

Terminated

• Conditions: Missed Abortion
• Interventions: Drug: misoprostol

• Registration Number: NCT01615224
• Lead Sponsor: Kristina Gemzell Danielsson

Brief Summary

Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Status Verified: 2019-08
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Last Update Submitted: 2019-12-14
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus

Exclusion Criteria

• empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repeated doses	misoprostol	patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment.

Primary Outcome Measures

Name	Time	Method
Efficacy	1 day	Complete abortion as judged by ultrasound

Secondary Outcome Measures

Name	Time	Method
Acceptability	1 day, 1 week, 2 weeks, 3 weeks, 5 weeks	questionnaire on future choice of treatment method. Surgical or medical treatment if free choice. If having to have medical would she choose repeated doses or single dose?

Trial Locations

Locations (1)

Dept of Obstetrics and Gynecology, Danderyd Hospital; 🇸🇪 Stockholm, Sweden