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

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a procedure called laparotomy closure in women who have been diagnosed with Twin-Twin Transfusion Syndrome (TTTS) or Twin Anemia-Polycythemia Sequence (TAPS). These conditions affect pregnancies with twins and can create imbalances in blood flow between the babies. The study aims to see if this surgical approach, combined with fetoscopic laser surgery, is safe and effective for treating these conditions.

To participate in this trial, women must be between 18 and 23 weeks pregnant, have a cervical length of more than 2.5 cm, and have a clear surgical path identified by an experienced doctor. Unfortunately, certain women may not be eligible, such as those with severe pregnancy complications or significant health issues. Participants can expect to undergo the laparotomy procedure and be monitored closely for their safety and the health of their babies throughout the study. This trial is currently recruiting, so if you or someone you know is affected by TTTS or TAPS, it might be worth considering participation.

Gender

FEMALE

Eligibility criteria

• 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.