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

Recruiting now · Not applicable

Conditions studied: Twin to Twin Transfusion Syndrome, Twin Anemia-Polycythemia Sequence

In brief

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.

Key facts

Study ID

NCT06991400

Run by

Children's Hospital Medical Center, Cincinnati

People needed

34

Starts

2024-11-01

Expected to finish

2026-06-01

Last updated by the study team

2025-05-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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