Viewing Study NCT00835003


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Study NCT ID: NCT00835003
Status: COMPLETED
Last Update Posted: 2014-07-03
First Post: 2009-02-02
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Timing of Planned Caesarean Section and Morbidity of the Newborn
Sponsor: Aarhus University Hospital
Organization:

Study Overview

Official Title: Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
Status: COMPLETED
Status Verified Date: 2014-06
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: The caesarean section rate is rising globally. About 10% of the newborns are submitted to a neonatal department after planned caesarean section, primarily with respiratory disorders. More children are submitted if caesarean is performed earlier in pregnancy.

Study hypothesis: More newborns are admitted after planned caesarean at 38 weeks and 3 days of gestation than after 39 weeks and 3 days of gestation.

Aim of study: To compare elective caesarean section performed at 38 weeks and 3 days of gestation with 39 weeks and 3 days of gestation. According to this timing to determine the proportion of newborns admitted within 48 hours after birth.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
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?: