Recruiting

Laparotomy Closure

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06991400

Conditions

Twin to Twin Transfusion Syndrome

Twin Anemia-Polycythemia Sequence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trans-Amniotic Suture Placement

Study Details

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 laparotomy closure.

Conditions

Twin to Twin Transfusion Syndrome

Twin Anemia-Polycythemia Sequence

Study ID

NCT06991400

Start date

Nov 1, 2024

Status verified date

May, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: yes stitch (will receive a larger stitch from laparotomy)

yes stitch for a larger stitch when receiving a laparotomy.

no intervention: No stitch

Interventions

Trans-Amniotic Suture Placement

Trans-Amniotic Suture placement

Primary outcome measure

  • Latency from surgery to delivery [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Kimberly Richards

513-636-2310kimberly.richards@cchmc.org

Erin Watters

513-803-7024erin.watters@cchmc.org

Locations

Cincinnati Childrens Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

May 28, 2025

Last verified

May, 2025

Keywords

  • fetoscopic surgery, laparotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-05-28.