Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141687
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-08-30
Brief Title:
Early External Cephalic Version ECV 2 Trial
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Early External Cephalic Version 2 Trial
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
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:
For women with a fetus in breech presentation does early ECV at 34 07 up to 35 weeks and 67 days versus delayed ECV not before 37 weeks and 07 days increase or decrease the likelihood of cesarean section CS
Detailed Description:
Primary Outcomes Rate of Caesarean section
Secondary Outcomes Rate of preterm birth
Other Outcomes admission to neonatal intensive care unit 24 hours perinatal or neonatal mortality or serious neonatal morbidity serious fetal complications maternal death or serious maternal morbidity non-cephalic presentation at birth womens views and health care costs
The Data Coordination for this study is being carried out at the Maternal Infant Reproductive Health Research Unit at Sunnybrook and Womens College Health Sciences Centre
Secondary Outcomes Rate of preterm birth
Other Outcomes admission to neonatal intensive care unit 24 hours perinatal or neonatal mortality or serious neonatal morbidity serious fetal complications maternal death or serious maternal morbidity non-cephalic presentation at birth womens views and health care costs
The Data Coordination for this study is being carried out at the Maternal Infant Reproductive Health Research Unit at Sunnybrook and Womens College Health Sciences Centre
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN56498577 | None | None | None |