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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

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 happen, as well as in fetoscopic surgery for another condition, myelomeningocele. Published data has shown that maternal laparotomy to suture closure of the port site at the time of fetoscopic surgery leads to improved pregnancy outcomes, later gestational age at delivery, and lower rates of preterm pre-labor rupture of membranes (PPROM) [PMID: 28910784].

Eligibility

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.

Study details
    Twin to Twin Transfusion Syndrome
    Twin Anemia-Polycythemia Sequence

NCT06991400

Children's Hospital Medical Center, Cincinnati

15 October 2025

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