NCT01622049

Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 77 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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 delivered fresh to Tampa General Hospital in an icebox container for assessment. Placentas will be discarded after analysis.

Conditions

• Twin Twin Transfusion Syndrome

Interventions

Type	Name	Description
DEVICE	Selective Laser Photocoagulation of Communicating Vessels	Patients will be admitted to Tampa General Hospital. Laboratory tests and anesthesia assessments will be completed. Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. Surgery will be performed preferably under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. Surgery will be performed with standard operative fetoscopy equipment and techniques. A trocar will be introduced in the amniotic cavity of the recipient. An amniotic fluid sample will be obtained for microbiological studies, and genetic analysis for clinical care only. The amniotic fluid will be discarded after analysis. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted. An amniodrainage of the larger sac may be performed

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2012-06-18
• Last updated: 2013-03-14

Locations

1 site across 1 country: United States