Recruiting

Fetoscopic Laser Photocoagulation

Sponsor:

Baylor College of Medicine

Code:

NCT06829901

Conditions

Twin to Twin Transfusion

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fetoscopic Laser Photocoagulation

Study Details

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.

Conditions

Twin to Twin Transfusion

Study ID

NCT06829901

Start date

Mar 14, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

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.

Primary outcome measure

  • Rate of Immediate Chorioamniotic Membrane Separation (CAS) [ Time Frame: Up to hospital discharge post-procedure (up to 5 days) ]

Central Contacts and Locations

Central contacts

Ahmed Nassr, MD, PhD

832-826-7449ahmed.nassr@bcm.edu

Becky Johnson, MS, CCRP

832-826-7451rj2@bcm.edu

Locations

Texas Children's Hospital - Pavilion for Women

Recruiting

Houston, Texas, United States, 77030

Contacts

Michael Belfort, MD, PhD

832-826-7375belfort@bcm.edu

Becky Johnson, MS, CCRP

832-826-7451rj2@bcm.edu

Principal Investigator:

Ahmed Nassr, MD, PhD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • fetoscopic laser photocoagulation
  • TTTS
  • uterine entry
  • direct entry
  • Seldinger technique
  • chorioamniotic membrane separation
  • CAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-03-04.