Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

NCT ID: NCT02122328

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 642 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-09
• Study Completion Date: 2023-10-31

Brief Summary

The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.

Conditions

Twin Twin Transfusion Syndrome

Study Design

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

Study Groups

Selective procedure

Selective laser photocoagulation of communicating vessels.

Group Type: ACTIVE_COMPARATOR

Selective laser photocoagulation of communicating vessels

Intervention Type: PROCEDURE

Sequential procedure

Sequential laser photocoagulation of communicating vessels

Group Type: EXPERIMENTAL

Sequential laser photocoagulation of communicating vessels.

Intervention Type: PROCEDURE

Interventions

Sequential laser photocoagulation of communicating vessels.

Intervention Type: PROCEDURE

Selective laser photocoagulation of communicating vessels

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
• Confirmed TTTS patients, who by definition meet the following sonographic criteria:

• Single placenta.
• Polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to amniodrainage.
• Oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to amniodrainage.
• Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic).
• Same gender, if visible.
• Quintero Stages 1-4.
• Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included.
• Patients with an anterior placenta may be included.
• Triplet gestations with two or three fetuses sharing the same placenta may be included.
• Patients must be able to give written informed consent.

Exclusion Criteria

• Patients unable or unwilling to participate in the study or to be followed up.
• Patients unable to give written informed consent.
• Presence of major congenital anomalies that may not warrant surgery.
• Known unbalanced chromosomal complement.
• Prior intentional septostomy (purposely making a hole in the dividing membrane).
• Ruptured membranes.
• Chorioamnionitis.
• Placental abruption.
• Active labor.
• Patient unwilling to receive blood products.
• Recipient twin with a middle cerebral artery peak systolic velocity > 1.5 multiples of the median (indicative of fetal anemia).
• Any other patient deemed inappropriate for the study by the principal investigator.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Ramen Chmait

Associate Professor, Clinical Obstetrics & Gynecology, Pediatrics, and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramen Chmait, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Hollywood Presbyterian Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

HS-09-00680

Identifier Type: -

Identifier Source: org_study_id