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The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective procedure | Active Comparator | Selective laser photocoagulation of communicating vessels. |
|
| Sequential procedure | Experimental | Sequential laser photocoagulation of communicating vessels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential laser photocoagulation of communicating vessels. | Procedure |
| ||
| Selective laser photocoagulation of communicating vessels |
| Measure | Description | Time Frame |
|---|---|---|
| To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV. | A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure. | Birth |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications | 21 post-operative days |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal/neonatal/infant outcomes | Birth to 6 months of life |
Inclusion Criteria:
Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
Confirmed TTTS patients, who by definition meet the following sonographic criteria:
Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included.
Patients with an anterior placenta may be included.
Triplet gestations with two or three fetuses sharing the same placenta may be included.
Patients must be able to give written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramen Chmait, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollywood Presbyterian Medical Center | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Procedure |
|
| D007232 |
| Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |