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โ† Trials
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Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery

RecruitingNAAges 18 Years - anyFemaleChildren's Hospital Medical Center, Cincinnati
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Trans-Amniotic Suture Placement
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Where

1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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