septate uterus uterine septum
Conditions
Interventions
Random allocation to hysteroscopic metroplasty or no intervention.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: Prior inclusion in the TRUST study. Contraindications for surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is live birth rate in each treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are complications following hysteroscopic metroplasty; uterine perforation, fluid overload, endometritis, clinical pregnancy and miscarriage. In a subsequent pregnancy, we will look at the prevalence of adversary pregnancy outcomes, placental abruption, premature delivery, uterine rupture, and mode of delivery (vaginal vs. caesarean section). | — |
Countries
Netherlands
Outcome results
None listed