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

Description

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.

Conditions

Twin to Twin Transfusion Syndrome, Twin Anemia-Polycythemia Sequence

Study Overview

Study Details

Study 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.

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

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

Condition
Twin to Twin Transfusion Syndrome
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Study Record Dates

2026-06-01