The Effect of Uterine Entry in Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome

Not Applicable

Recruiting

• Conditions: Twin to Twin Transfusion

• Registration Number: NCT06829901
• Lead Sponsor: Baylor College of Medicine

Brief Summary

The purpose of this study is to evaluate whether the entry technique surgeons use to get inside the uterus to perform fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome has an effect on the rates of chorioamniotic membrane separation.

Detailed Description

Patients who choose to undergo fetoscopic selective laser photocoagulation (SFLP) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and participants will be provided a copy of the signed consent.

After consent has been obtained, participants will be randomized into two groups ("direct entry" and "Seldinger technique").

Procedure: Selective laser photocoagulation (SFLP) is standard of care for the treatment of complicated monochorionic twin pregnancies. Entry into the uterus for SFLP is achieved under ultrasound guidance using one of two accepted methods, direct entry or the Seldinger technique. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure.

Group I - Direct entry: The surgeon will gain access to the uterus by inserting a sharp trocar through a small incision in the skin. After access has been established, the trocar is removed and a small tube called a cannula is left in place.

Group II - Seldinger technique: The surgeon will gain access to the uterus by inserting needle through a small incision in the skin and run a guide wire through the needle so a thin tube called a cannula can be placed over the wire.

Follow-Up:

Participants will be monitored after the procedure and upon discharge from the hospital they are free to resume care with their primary doctor. Investigators will collect follow-up data on the health of the participant and the babies until the babies turn one month old.

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-02-11
• Status Verified: 2025-03
• Study Start: 2025-03-14
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2029-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 216

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Immediate Chorioamniotic Membrane Separation (CAS)	Up to hospital discharge post-procedure (up to 5 days)	Number of participants that have chorioamniotic membrane separation within 24 hours of the procedure.

Secondary Outcome Measures

Name	Time	Method
Preterm Birth	At delivery	Number of participants that deliver at \<37 weeks gestation
Procedure to Delivery Interval	At delivery	Days between the participant's procedure and when the babies are delivered
Rate of Chorioamniotic Membrane Separation (CAS)	From the post-surgical period (outside the first 24 hours) until delivery, up to 25 weeks	Number of participants that have chorioamniotic membrane separation outside the first 24 hours hours following the procedure
Gestational Age at Delivery	At delivery	Gestational age at the time of delivery
Placental Abruption	Up to hospital discharge post-procedure (up to 5 days)	As measured by presence in medical record
Chorioamnionitis	Up to hospital discharge post-procedure (up to 5 days)	As measured by presence in medical record
Septostomy	Up to hospital discharge post-procedure (up to 5 days)	As measured by presence in medical record
Preterm Premature Rupture of Membranes (PPROM)	At delivery	As measured by presence in medical record

Trial Locations

Locations (1)

Texas Children's Hospital - Pavilion for Women; 🇺🇸 Houston, Texas, United States