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

NCT ID: NCT06829901

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2030-12-31

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.

Conditions

Twin to Twin Transfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct Entry

Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting a sharp trocar through a small incision in the skin. The trocar is then removed and a small tube called a cannula is left in place.

Group Type: ACTIVE_COMPARATOR

Fetoscopic Laser Photocoagulation

Intervention Type: PROCEDURE

Patients who choose to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome will be offered participation in the study. All participants will undergo selective laser photocoagulation and entry into the uterus will be achieved using one of two accepted methods, either direct entry or the Seldinger technique.

Seldinger Technique

Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting needle through a small incision in the skin and running a guide wire through the needle so a thin tube called a cannula can be placed over the wire.

Group Type: ACTIVE_COMPARATOR

Fetoscopic Laser Photocoagulation

Intervention Type: PROCEDURE

Patients who choose to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome will be offered participation in the study. All participants will undergo selective laser photocoagulation and entry into the uterus will be achieved using one of two accepted methods, either direct entry or the Seldinger technique.

Interventions

Fetoscopic Laser Photocoagulation

Patients who choose to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome will be offered participation in the study. All participants will undergo selective laser photocoagulation and entry into the uterus will be achieved using one of two accepted methods, either direct entry or the Seldinger technique.

Intervention Type: PROCEDURE

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Nassr

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Nassr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital - Pavilion for Women

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ahmed Nassr, MD, PhD

Role: CONTACT

ahmed.nassr@bcm.edu

832-826-7449

Becky Johnson, MS, CCRP

Role: CONTACT

rj2@bcm.edu

832-826-7451

Facility Contacts

Michael Belfort, MD, PhD

Role: primary

belfort@bcm.edu

832-826-7375

Becky Johnson, MS, CCRP

Role: backup

rj2@bcm.edu

832-826-7451

Other Identifiers

H-56175

Identifier Type: -

Identifier Source: org_study_id