Laser treatment for twin-to-twin transfusion syndrome
Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome (TTTS)
This study is testing if a laser treatment can improve outcomes for pregnant women with twin-to-twin transfusion syndrome by targeting the blood vessels connecting their twins.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | Female |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Trial ID | NCT05008744 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of diode laser photocoagulation on communicating vessels in cases of twin-to-twin transfusion syndrome (TTTS). Patients will undergo a thorough evaluation, including ultrasound assessments to check for congenital anomalies and fetal health. The procedure involves fetoscopic laser ablation performed under anesthesia, guided by ultrasound to ensure precision. Data on maternal and fetal outcomes will be collected to assess the procedure's impact.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with monochorionic twins diagnosed with TTTS, characterized by polyhydramnios in one twin and oligohydramnios in the other.
Not a fit: Patients with major congenital anomalies, active pre-term labor, or other serious complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for mothers and their twins affected by TTTS.
How similar studies have performed: Previous studies have shown promising results with fetoscopic laser ablation in TTTS, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Single placenta (Monochorionic) * Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age) * Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket) * Prominent bladder in the recipient/ non-filling bladder in the donor * Thin dividing membrane Exclusion Criteria: * Patients unwilling to participate in the study or to be followed up * Presence of major congenital anomalies incompatible with survival * Active pre-term labor Ruptured membranes * Chorioamnionitis * Vaginal bleeding
Where this trial is running
Seattle, Washington and 1 other locations
- Seattle Childrens Hospital — Seattle, Washington, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Martin P Walker, MD — Seattle Childrens Hospital
- Study coordinator: Martin P Walker, MD
- Email: martin.walker@seattlechildrens.org
- Phone: 206-987-3539
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.