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

NCT02122328 | Completed DMC

• 1 other identifier: HS-09-00680
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 1

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

Keywords

Twin twin transfusion syndrome; Sequential laser photocoagulation of communicating vessels

Outcome Measures

Primary Outcomes (1)

• To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.

  A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure.

  Birth

Secondary Outcomes (1)

• Surgical complications

  21 post-operative days

Other Outcomes (1)

• Fetal/neonatal/infant outcomes

  Birth to 6 months of life

Study Arms (2)

Selective procedure

ACTIVE COMPARATOR

Selective laser photocoagulation of communicating vessels.

Procedure: Selective laser photocoagulation of communicating vessels

Sequential procedure

EXPERIMENTAL

Sequential laser photocoagulation of communicating vessels

Procedure: Sequential laser photocoagulation of communicating vessels.

Interventions

Sequential laser photocoagulation of communicating vessels. PROCEDURE

Sequential procedure

Selective laser photocoagulation of communicating vessels PROCEDURE

Selective procedure

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Hollywood Presbyterian Medical Center

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ramen Chmait, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

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, Clinical Obstetrics & Gynecology, Pediatrics, and Surgery

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 24, 2014
• Study Start: June 9, 2010
• Primary Completion: April 30, 2023
• Study Completion: October 31, 2023
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)