Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

Status unconfirmed · Not applicable

Conditions studied: Twin to Twin Transfusion Syndrome

In brief

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

Key facts

Study ID

NCT00345852

Run by

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

People needed

150

Starts

2002-03-01

Expected to finish

2007-05-01

Last updated by the study team

2007-06-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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