Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
1 other identifier
interventional
150
1 country
12
Brief Summary
This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation \[SFLP\]) in patients with severe twin to twin transfusion syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2002
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 27, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 29, 2007
June 1, 2006
June 27, 2006
June 28, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of California-San Francisco
San Francisco, California, 94143, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
New York University School of Medicine
New York, New York, 10016, United States
Columbia-Presbyterian Medical Center
New York, New York, 10032, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Utah Hospital
Salt Lake City, Utah, 84143, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy M Crombleholme, MD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 27, 2006
First Posted
June 29, 2006
Study Start
March 1, 2002
Study Completion
May 1, 2007
Last Updated
June 29, 2007
Record last verified: 2006-06