Controlled amnioreduction for twin-to-twin transfusion syndrome
Feto-Fetal Transfusion Syndrome in Multiple Pregnancies
This study tests if a procedure that removes extra amniotic fluid can help treat twin-to-twin transfusion syndrome in pregnant women with identical twins and improve the long-term health of the babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Sex | Female |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT04148859 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a controlled amnioreduction procedure for treating twin-to-twin transfusion syndrome (TTTS) in pregnancies with monochorionic twins. The approach involves measuring amniotic pressure while removing fluid to alleviate complications associated with TTTS. Eleven patients with severe TTTS at stages II and III of the Quintero classification were enrolled, and their umbilical artery S/D ratios were monitored throughout the procedure. The long-term neurodevelopmental outcomes of the surviving twins were assessed through a health questionnaire.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with severe twin-to-twin transfusion syndrome.
Not a fit: Patients with pregnancies that have malformations or genetic pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly improve outcomes for twins affected by TTTS, potentially reducing the risk of preterm delivery and neurodevelopmental deficits.
How similar studies have performed: Other studies have explored similar interventions for TTTS, indicating potential for success, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnancies with TTTS Exclusion Criteria: * Pregnancies with malformations or genetic pathologies
Where this trial is running
Tel Aviv
- Zoya Gordon — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Ariel J Jaffa, MD — Ultrasound Unit in Obstetrics and Gynecology, Lis Maternity Hospital
- Study coordinator: Zoya Gordon, PhD
- Email: zoyag@tasmc.health.gov.il
- Phone: 972-3-692-5759
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.