Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Ohio
Cincinnati Childrens Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Kimberly Richards
kimberly.richards@cchmc.org
513-636-2310
Backup
Erin Watters
erin.watters@cchmc.org
513-803-7024
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 34
Treatments
Experimental: yes stitch (will receive a larger stitch from laparotomy)
yes stitch for a larger stitch when receiving a laparotomy.
No_intervention: No stitch
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati