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Recruiting NCT06991400

Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery

Trial Parameters

Condition Twin to Twin Transfusion Syndrome
Sponsor Children's Hospital Medical Center, Cincinnati
Study Type INTERVENTIONAL
Phase N/A
Enrollment 34
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-11-01
Completion 2026-06-01
Interventions
Trans-Amniotic Suture Placement

Brief Summary

This is a randomized trial for patients that are diagnosed with Twin-Twin Transfusion Syndrome (TTTS) who are receiving a fetoscopic laser surgery to evaluate the effectiveness and safety of a laparotomy closure.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of TTTS or Twin Anemia-Polycythemia Sequence (TAPS) * Gestational age between 18 weeks and 23 weeks (18 0/7 to 22 6/7 weeks) * Cervical length \>2.5 cm preoperatively * Identification of a safe percutaneous surgical window by a provider experienced in fetoscopic surgery prior to entering the operating room Exclusion Criteria: * Higher order pregnancies, chromosomal or severe congenital anomalies, undergoing laser surgery for fetal growth restriction only, need for a second laser during pregnancy, failure to complete laser, PPROM prior to surgery. BMI\> 40 at the start of pregnancy, emergent case (i.e. surgery occurs \< 6 hours from presentation), significant fetal anomalies expected to drastically alter the risk of neonatal morbidity or mortality (i.e. anencephaly, cyanotic heart disease), or any significant maternal comorbidities as determined by physician i.e.: clotting disorders/blood disorders.

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