Status:
UNKNOWN
Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Conditions:
Twin to Twin Transfusion Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
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.
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00345852
Start Date
March 1 2002
End Date
May 1 2007
Last Update
June 29 2007
Active Locations (12)
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1
University of California-San Francisco
San Francisco, California, United States, 94143
2
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
3
New York University School of Medicine
New York, New York, United States, 10016
4
Columbia-Presbyterian Medical Center
New York, New York, United States, 10032