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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06829901
Status
Recruiting
Apply to this trial

Conditions

  • Twin to Twin Transfusion

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fetoscopic Laser Photocoagulation — 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.

Study Details

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.

Key Dates

Start date
Mar 14, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's Hospital - Pavilion for WomenHoustonTexas77030
Michael Belfort, MD, PhD
[email protected]
832-826-7375
Becky Johnson, MS, CCRP
[email protected]
832-826-7451
Ahmed Nassr, MD, PhD (PRINCIPAL_INVESTIGATOR)
Michael Belfort, MD, PhD (SUB_INVESTIGATOR)
Magdalena Sanz Cortes, MD, PhD (SUB_INVESTIGATOR)
Roopali Donepudi, MD (SUB_INVESTIGATOR)
Jessian Munoz, MD, PhD (SUB_INVESTIGATOR)
Cara Buskmiller, MD (SUB_INVESTIGATOR)
Brian Burnett, MD (SUB_INVESTIGATOR)

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By research site
Texas Children's Hospital - Pavilion for Women· Houston, TX