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Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
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
First received: June 27, 2006
Last updated: June 28, 2007
Last verified: June 2006
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Timothy M Crombleholme, MD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00345852     History of Changes
Obsolete Identifiers: NCT00109694
Other Study ID Numbers: R01-HD41149
Study First Received: June 27, 2006
Last Updated: June 28, 2007
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

Additional relevant MeSH terms:
Fetofetal Transfusion
Syndrome
Anemia
Anemia, Neonatal
Disease
Hematologic Diseases
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014