Evaluating uterine entry techniques for laser treatment in twin-to-twin transfusion syndrome
The Effect of Entry Technique on Chorioamniotic Membrane Separation in Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome
This study is testing whether different ways to enter the uterus for laser treatment can improve outcomes for pregnant women with twin-to-twin transfusion syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06829901 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of different uterine entry techniques on the outcomes of fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome (TTTS). Patients at Texas Children's Fetal Center who choose to undergo this procedure will be invited to participate and will undergo a thorough informed consent process. Eligible participants will be randomly assigned to either a direct entry group or a Seldinger technique group for the procedure. The study will focus on the rates of chorioamniotic membrane separation as a primary outcome measure.
Who should consider this trial
Good fit: Ideal candidates are patients with complicated monochorionic-diamniotic twin pregnancies diagnosed with twin-to-twin transfusion syndrome who opt for fetoscopic laser photocoagulation.
Not a fit: Patients who do not choose to undergo fetoscopic laser photocoagulation or those with triplet or higher order multiple gestations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce complications for patients undergoing treatment for TTTS.
How similar studies have performed: While the approach of using different entry techniques is established, this specific comparison in the context of TTTS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome. * Patients will be between 16 0/7 weeks and 26 0/7 weeks gestational age. Exclusion Criteria: * Patients who do not elect to undergo fetoscopic laser photocoagulation for the treatment of complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome. * Triplets and higher order multiple gestations. * Patients who are less than 16 0/7 weeks or greater than 26 0/7 weeks gestational age. * Patients with a short cervix (less than 1.5 cm). * Patients with a known subchorionic hemorrhage.
Where this trial is running
Houston, Texas
- Texas Children's Hospital - Pavilion for Women — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ahmed Nassr, MD, PhD — Baylor College of Medicine
- Study coordinator: Ahmed Nassr, MD, PhD
- Email: ahmed.nassr@bcm.edu
- Phone: 832-826-7449
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.