Clinical Trial: Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

Brief Summary: Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Patients will be counseled about the risks and benefits of all treatment options and will be free to choose any treatment option. They will then be asked to sign an informed consent. The procedure will be performed under local anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. An accessory port may be required in some cases. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted often during the procedure. An amniodrainage of the larger sac may be performed at the time of the procedure. The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on the first post operative day. Patients will undergo a weekly ultrasound examination for four weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders, absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein, ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive care unit will be followed through their discharge. Evidence of neurological or cardiac morbidity will be sought in each twin. If either of these complications is suspected, evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be followed up for neonatal, infant and childhood morbidity or mortality. It is requested that all placentas be

Detailed Summary:
Sponsor: University of South Florida

Current Primary Outcome: The primary study objective is to evaluate neonatal/infant survival 6 months after birth. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary study objective is to evaluate the effects of surgery on postnatal neurological morbidity. For the purposes of this clinical trial, neurological morbidity includes any of the following conditions diagnosed within 6 months of birth [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: University of South Florida

Dates:
Date Received: August 5, 2010
Date Started: October 2006
Date Completion:
Last Updated: March 13, 2013
Last Verified: November 2012