Which is the optimal treatment for miscarriage with a gestational sac in the uterus and which factors can predict if the treatment will be successful?

• Conditions: Miscarriage before 14 gestational weeks with a gestational sac in the uterus identified at ultrasound examiantion; MedDRA version: 9.1Level: LLTClassification code 10027650Term: Miscarriage of pregnancy

• Registration Number: EUCTR2007-007661-20-SE
• Lead Sponsor: il Valentin, Region Skåne, Malmö University Hospital, Dpt Obstetrics and Gynecology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

-at least 18 years of age
-able to understand the information
-incomplete miscarriage before 14 weeks, bleeding, closed cervix, gestational sac retained in the uterus (empty with size 16 mm or more or dead embryo 5 - 33 mm, or arrest in development of the pregnancy during at least 7 days of observation)
-circulatory stable
-Hemoglobin level at least 80g/L
-no contraindications against use of misoprostol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(exclusion criteria = Not eligible)
-Intrauterine pregnancy of uncertain viability
-non-viable pregnancy WITHOUT bleeding
-profuse bleeding requiring immediate surgical evacuation of the uterus
-contraindications against misoprostol

Exclusions
Lost to follow-up
Severe hitherto unknown side effects of misoprostol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified