Actively Recruiting
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-05-28
34
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 surgery
- Preterm pre-labor rupture of membranes prior to surgery
- Body mass index greater than 40 at the start of pregnancy
- Emergent cases where surgery occurs less than 6 hours from presentation
- Significant fetal anomalies expected to drastically alter neonatal risk (e.g., anencephaly, cyanotic heart disease)
- Significant maternal comorbidities such as clotting or blood disorders as determined by a physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
K
Kimberly Richards
CONTACT
E
Erin Watters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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