The Randomised Uterine Septum Transsection Trial
Completed
- Conditions
- septate uterusuterine septum100002111001061210029903
- Registration Number
- NL-OMON37108
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 67
Inclusion Criteria
The trial will study women with a history of recurrent miscarriage or pregnancy loss before 20 weeks of gestational age and/or subfertility and a septate uterus. Recurrent miscarriage is defined as two or more, not necessarily consecutive, pregnancy losses before 20 weeks of gestational age. Subfertility is defined as the inability to conceive for a minimal period of one year. Only women with an active wish to conceive will be eligible.
Exclusion Criteria
Prior inclusion in the TRUST study.
Contraindications for surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is live birth rate in each treatment group.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are complications following hysteroscopic metroplasty;<br /><br>uterine perforation, fluid overload, endometritis, clinical pregnancy and<br /><br>miscarriage. In a subsequent pregnancy, we will look at the prevalence of<br /><br>adversary pregnancy outcomes, placental abruption, premature delivery, uterine<br /><br>rupture, and mode of delivery (vaginal vs. caesarean section).</p><br>