Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery (NCT06991400) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
United States34 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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.
What they're measuring
1
Latency from surgery to delivery
Timeframe: 4 months
Trial details
NCT IDNCT06991400
SponsorChildren's Hospital Medical Center, Cincinnati