Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Phase 3TerminatedNCT01615224

Kristina Gemzell Danielsson23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Missed Abortion

Interventions

misoprostolDRUG

repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept of Obstetrics and Gynecology, Danderyd Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Efficacy

Complete abortion as judged by ultrasound

Time frame: 1 day

Secondary Outcomes

Acceptability

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?

Time frame: 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks

Data from ClinicalTrials.gov

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