TTTS 1 trial: A cluster randomized controlled trial comparing a conservative management and primary laser surgery in stage 1 TTTS.
Completed
- Conditions
- Twin to Twin Transfusium Syndrome10010273
- Registration Number
- NL-OMON46996
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Eligible patients are women with monochorionic, diamniotic twin pregnancies presenting with stage 1 TTTS defined according to the Eurofoetus criteria between 16+0 and 26+6 weeks of gestation. Maternal age > 18 years.
Exclusion Criteria
Patients with a cervix less than 15 mm on transvaginal scan or severe maternal discomfort are excluded as these require immediate treatment. Patients with ruptured membranes or with fetal malformations will be excluded. Also language problems for informed consent are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This composite outcome characterizes the babies alive at 6 months without<br /><br>neurological sequelae. Neurological sequelae are defined as cystic<br /><br>periventricular leukomalacia, severe intraventricular hemorrhage (stage 3 or<br /><br>4), blindness or deafness. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• 6 months and 2 year intact survival of both twins<br /><br>• Perinatal, 6 months and 2 year survival of at least one twin<br /><br>• Perinatal, 6 months and 2 year survival of both twins<br /><br>• Complications of prematurity at 6 months and 2 years (necrotizing<br /><br>enterocolitis >= stage 2, bronchopulmonary dysplasia, renal failure, retinopathy<br /><br>of prematurity, time spent in NICU)<br /><br>• Neurological morbidity at 2 years as defined by any of: cerebral palsy<br /><br>according to the European CP network, blindness, severe deafness requiring<br /><br>amplification, or abnormal scores on the Bayley's test. A Bayley's test will be<br /><br>considered abnormal if the mental developmental indexes (MDI) or psychomotor<br /><br>development indexes (PDI) are under 70.<br /><br>• Maternal and obstetrical morbidity</p><br>