RecruitingNot ApplicableNCT06991400
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
34 participants
Start Date
Nov 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- 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 Criteria1
- 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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Interventions
OTHERTrans-Amniotic Suture Placement
Trans-Amniotic Suture placement
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06991400