Surgery to improve outcomes in Twin-Twin Transfusion Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.