Evaluating uterine entry techniques for laser treatment in twin-to-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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.