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

Cincinnati Children's Hospital Medical Center

Status

Enrolling

Conditions

Twin Anemia-Polycythemia Sequence

Twin to Twin Transfusion Syndrome

Treatments

Other: Trans-Amniotic Suture Placement

Study type

Interventional

Funder types

Other

Identifiers

NCT06991400

2024-0006

Details and patient eligibility

About

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.

Full 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].

Enrollment

34 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.