Overview

This trial is active, not recruiting.

Condition abortion, spontaneous
Treatment misoprostol
Sponsor Region Skane
Start date October 2008
End date December 2015
Trial size 190 participants
Trial identifier NCT01033903, EudraCT 2007-007661-20

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
misoprostol
800 micrograms intravaginally ONCE
(No Intervention)

Primary Outcomes

Measure
complete miscarriage
time frame: 10 days

Secondary Outcomes

Measure
complete miscarriage
time frame: 17 days, 24 days, 31 days

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Which is the Optimal Treatment for Miscarriage With a Gestational ac in the Uterus and Which Factors Can Predict if the Treatment Will be Successful?
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Region Skane.