NCT06829901

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Mar 2025Dec 2030

First Submitted

Initial submission to the registry

January 31, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

March 14, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

January 31, 2025

Last Update Submit

March 3, 2026

Conditions

Twin to Twin Transfusion

Keywords

fetoscopic laser photocoagulationTTTSuterine entrydirect entrySeldinger techniquechorioamniotic membrane separationCAS

Outcome Measures

Primary Outcomes (1)

  • Rate of Immediate Chorioamniotic Membrane Separation (CAS)

    Number of participants that have chorioamniotic membrane separation within 24 hours of the procedure.

    Up to hospital discharge post-procedure (up to 5 days)

Secondary Outcomes (8)

  • Rate of Chorioamniotic Membrane Separation (CAS)

    From the post-surgical period (outside the first 24 hours) until delivery, up to 25 weeks

  • Gestational Age at Delivery

    At delivery

  • Preterm Birth

    At delivery

  • Procedure to Delivery Interval

    At delivery

  • Placental Abruption

    Up to hospital discharge post-procedure (up to 5 days)

  • +3 more secondary outcomes

Study Arms (2)

Direct Entry

ACTIVE COMPARATOR

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.

Procedure: Fetoscopic Laser Photocoagulation

Seldinger Technique

ACTIVE COMPARATOR

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.

Procedure: Fetoscopic Laser Photocoagulation

Interventions

Fetoscopic Laser PhotocoagulationPROCEDURE

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.

Direct EntrySeldinger Technique

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital - Pavilion for Women

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ahmed Nassr, MD, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Nassr, MD, PhD

CONTACT

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

Becky Johnson, MS, CCRP

CONTACT

832-826-7451rj2@bcm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 17, 2025

Study Start

March 14, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(1)