Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345852
Status:
UNKNOWN
Last Update Posted:
2007-06-29
First Post:
2006-06-27
Brief Title:
Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
A Prospective Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None