Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

This study is ongoing, but not recruiting participants.

First Received: June 27, 2006 Last Updated: June 28, 2007 History of Changes

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Children's Hospital Medical Center, Cincinnati
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00345852

Purpose

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

Condition	Intervention
Twin to Twin Transfusion Syndrome	Procedure: Fetoscopic Selective Laser Photocoagulation

MedlinePlus related topics: Blood Transfusion and Donation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

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:

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

Estimated Enrollment:	150
Study Start Date:	March 2002
Estimated Study Completion Date:	May 2007

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345852

Locations

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

Sponsors and Collaborators

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

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator:

Timothy M Crombleholme, MD

Children's Hospital Medical Center, Cincinnati

More Information

Additional Information:

Fetal Care Center of Cincinnati Twin-Twin Transfusion Syndrome (TTTS) webpage This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	R01-HD41149
Study First Received:	June 27, 2006
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00345852 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

twin to twin transfusion syndrome
fetoscopic selective laser photocoagulation
amnioreduction

Study placed in the following topic categories:

Fetofetal Transfusion
Hematologic Diseases
Anemia

Infant, Newborn, Diseases
Twin Twin Transfusion Syndrome
Anemia, Neonatal

Additional relevant MeSH terms:

Pathologic Processes
Disease
Fetofetal Transfusion
Hematologic Diseases

Syndrome
Anemia
Infant, Newborn, Diseases
Anemia, Neonatal

ClinicalTrials.gov processed this record on May 07, 2009