NCT00345852

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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, 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

Conditions

• Twin to Twin Transfusion Syndrome

Interventions

Type	Name	Description
PROCEDURE	Fetoscopic Selective Laser Photocoagulation

Timeline

• Start date: 2002-03-01
• Completion: 2007-05-01
• First posted: 2006-06-29
• Last updated: 2007-06-29

Locations

12 sites across 1 country: United States