Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

June 28, 2007 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome

This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of twin-twin transfusion syndrome (TTTS). We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage II-IV) twin-twin transfusion syndrome (TTTS). Primary Outcomes: Survival of donor twin at 30 days after birth and no treatment failure; Survival of recipient twin at 30 days after birth and no treatment failure; Secondary Outcomes: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth); Gestational age at delivery; Placental insufficiency; Cardiac outcome: echocardiographic evidence of cardiac compromise; Neurologic outcome: evidence of brain injury preceding birth by MRI; Postnatal comorbidity

Study Type

Interventional

Enrollment

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California-San Francisco
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10032
        • Columbia-Presbyterian Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Women's Hospital
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • University of Utah Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Both twins are alive
  • TTTS diagnosed prior to 22 weeks gestation
  • Monochorionic diamniotic gestation
  • Like sex twins
  • Single placental mass
  • Thin intertwin membrane
  • Oligohydramnios in donor twin (deepest vertical pocket of ≤ 2 cm)
  • Polyhydramnios with deepest vertical pocket of > 8 cm with or without Doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of > 6 cm if previous amnioreduction)
  • Decompressed bladder in donor not seen to fill during the ultrasound examination (stage II, III, or IV), unless Doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present
  • No associated structural abnormalities
  • No sonographic evidence of CNS injury at time of entry
  • No preterm labor
  • No maternal medical contraindication to anesthesia or surgery

Exclusion Criteria:

  • Failure to meet all inclusion criteria
  • TTTS presenting after 22 weeks gestation
  • Randomization after 24 weeks gestation
  • Cervical length < 2.0 cm post initial
  • Presence of cervical cerclage
  • Uterine anomaly
  • Refusal to accept randomization
  • Unable to pursue prenatal care at an approved center coordinated by one of the participating institutions
  • Unable to pursue postnatal evaluation at a NICHD Neonatal Research Network Institution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival of donor twin at 30 days after birth and no treatment failure
Survival of recipient twin at 30 days after birth and no treatment failure

Secondary Outcome Measures

Outcome Measure
Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
Gestational age at delivery
Placental insufficiency
Cardiac outcome: echocardiographic evidence of cardiac compromise
Neurologic outcome: evidence of brain injury preceding birth by MRI
Postnatal comorbidity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Timothy M Crombleholme, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion

May 1, 2007

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Estimate)

June 29, 2007

Last Update Submitted That Met QC Criteria

June 28, 2007

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD041149 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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