Surgery to improve outcomes in Twin-Twin Transfusion Syndrome
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
NA · Children's Hospital Medical Center, Cincinnati · NCT06991400
This study is testing if closing the hole in the amniotic membrane during surgery for Twin-Twin Transfusion Syndrome can lead to healthier pregnancies and better delivery outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06991400 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of laparotomy closure during fetoscopic laser surgery for patients diagnosed with Twin-Twin Transfusion Syndrome (TTTS). The study aims to determine if suturing the amniotic membrane hole can lead to better pregnancy outcomes, including a longer gestational age at delivery and reduced rates of preterm rupture of membranes. Participants will be randomly assigned to receive either the standard treatment or the intervention involving trans-amniotic suture placement. The study is designed to gather data on the benefits of this surgical approach compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals diagnosed with TTTS or Twin Anemia-Polycythemia Sequence between 18 and 23 weeks of gestation.
Not a fit: Patients with higher order pregnancies, significant fetal anomalies, or severe maternal comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pregnancy outcomes for mothers and their twins affected by TTTS.
How similar studies have performed: Previous studies have shown that laparotomy for suture closure during fetoscopic surgery can improve pregnancy outcomes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Kimberly Richards
- Email: kimberly.richards@cchmc.org
- Phone: 513-636-2310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Twin to Twin Transfusion Syndrome, Twin Anemia-Polycythemia Sequence, fetoscopic surgery, laparotomy