Clinical Trial: Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome

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

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

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

Dates:
Date Received: June 27, 2006
Date Started: March 2002
Date Completion: May 2007
Last Updated: June 28, 2007
Last Verified: June 2006