NCT06991400

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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) \[PMID: 28910784\].

Conditions

• Twin to Twin Transfusion Syndrome
• Twin Anemia-Polycythemia Sequence

Interventions

Type	Name	Description
OTHER	Trans-Amniotic Suture Placement	Trans-Amniotic Suture placement

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: United States