Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Trans-Amniotic Suture Placement
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov