Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
NCT ID: NCT00345852
Last Updated: 2007-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2002-03-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Fetoscopic Selective Laser Photocoagulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Timothy M Crombleholme, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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University of California-San Francisco
San Francisco, California, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
New York University School of Medicine
New York, New York, United States
Columbia-Presbyterian Medical Center
New York, New York, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Magee-Women's Hospital
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Related Links
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Fetal Care Center of Cincinnati Twin-Twin Transfusion Syndrome (TTTS) webpage
Other Identifiers
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NCT00109694
Identifier Type: -
Identifier Source: nct_alias