Solomon study
- Conditions
- Twin-to-twin transfusion syndrome Twin anemia-polycythemia sequenceFetoscopic laser surgery
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 184
Inclusion Criteria
1. All TTTS pregnancies eligible for laser surgery up to 26 weeks’ gestation.
Exclusion Criteria
1. Triplet pregnancies
2. Language problems for informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure will be the prevalence of TAPS or recurrence of TTTS. <br><br>4-7-2013: An adjustment to the primary outcome and sample size calculation was made after the start of recruitment and was approved by the medical ethics committee (P07.261). The initial primary outcome was reduction of TAPS and recurrent TTTS and sample size was based on a reduction of 15% (20% in the Solomon group versus 5% in the Selective group). Secondary outcomes were perinatal mortality and neonatal morbidity. Since it was of high importance to show that the use of the new treatment modality would not have a negative effect on perinatal mortality and neonatal morbidity, we therefore included perinatal mortality and severe neonatal morbidity in the primary outcome. The expected reduction of the composite outcome of 15%, with 45% in the Solomon group and 60% in the selective group, increased the sample size from 184 to 274 patients.
- Secondary Outcome Measures
Name Time Method Secondary outcomes include residual anastomoses on placental injection, perinatal mortality and neonatal morbidity.