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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopic Selective Laser Photocoagulation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy M Crombleholme, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-San Francisco | San Francisco | California | 94143 | United States | ||
| Evanston Northwestern Healthcare |
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| Label | URL |
|---|---|
| Fetal Care Center of Cincinnati Twin-Twin Transfusion Syndrome (TTTS) webpage | View source |
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| Cardiac outcome: echocardiographic evidence of cardiac compromise |
| Neurologic outcome: evidence of brain injury preceding birth by MRI |
| Postnatal comorbidity |
| 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 |
| ID | Term |
|---|---|
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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