Status:
RECRUITING
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Twin to Twin Transfusion Syndrome
Twin Anemia-Polycythemia Sequence
Eligibility:
FEMALE
18+ years
Phase:
NA
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 laparot...
Detailed Description
The rationale behind suturing the hole is that the amniotic membrane does not close itself, rather you are relying that the uterus closes over the hole in the amniotic membrane, which may or may not h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06991400
Start Date
November 1 2024
End Date
June 1 2026
Last Update
May 28 2025
Active Locations (1)
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1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229