Optimal Treatment of Miscarriage

Not Applicable

Completed

• Conditions: Abortion, Spontaneous
• Interventions: Drug: misoprostol

• Registration Number: NCT01033903
• Lead Sponsor: Region Skane

Brief Summary

The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-01
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Primary Completion: 2015-12
• Study Completion: 2018-03-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

Inclusion Criteria

• nonviable intrauterine pregnancy with retained gestational sac in the uterus
• the embryo if visible 5 to 35 mm without a heart beat
• vaginal bleeding
• circulatory stable
• hemoglobin at least 80 g/L

Exclusion Criteria

• contraindications against misoprostol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol 800 micrograms intravaginally	misoprostol	-

Primary Outcome Measures

Name	Time	Method
complete miscarriage	10 days

Secondary Outcome Measures

Name	Time	Method
complete miscarriage	17 days, 24 days, 31 days

Trial Locations

Locations (1)

Region Skane, Kvinnokliniken, University Hopsital MAS; 🇸🇪 Malmö, Sweden