Trial Outcomes & Findings for Timing of Planned Caesarean Section and Morbidity of the Newborn (NCT NCT00835003)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1273 participants

Primary outcome timeframe

48 hours

Results posted on

2014-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	38 Weeks Group Elective caesarean section at 38 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)	39 Weeks Group Elective caesarean section at 39 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
Overall Study STARTED	636	638
Overall Study COMPLETED	636	638
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Timing of Planned Caesarean Section and Morbidity of the Newborn

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	38 Weeks Group n=636 Participants Elective caesarean section at 38 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)	39 Weeks Group n=638 Participants Elective caesarean section at 39 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)	Total n=1274 Participants Total of all reporting groups
Age, Continuous	32.1 years STANDARD_DEVIATION 4.4 • n=39 Participants	31.6 years STANDARD_DEVIATION 4.6 • n=41 Participants	31.8 years STANDARD_DEVIATION 4.0 • n=35 Participants
Sex: Female, Male Female	636 Participants n=39 Participants	638 Participants n=41 Participants	1274 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment Denmark	636 participants n=39 Participants	638 participants n=41 Participants	1274 participants n=35 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	38 Weeks Group n=635 Participants Elective caesarean section at 38 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)	39 Weeks Group n=637 Participants Elective caesarean section at 39 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
Neonatal Admission After Elective Caesarean Section	88 participants	76 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 months post partum

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From birth until 2 years of age

Outcome measures

Outcome data not reported

Adverse Events

38 Weeks Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

39 Weeks Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	38 Weeks Group n=636 participants at risk Elective caesarean section at 38 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)	39 Weeks Group n=638 participants at risk Elective caesarean section at 39 weeks and 3 days of gestation Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
Pregnancy, puerperium and perinatal conditions Fetal death	0.16% 1/636 • 30 days	0.16% 1/638 • 30 days
Respiratory, thoracic and mediastinal disorders Neonatal death	0.00% 0/636 • 30 days	0.16% 1/638 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

MD, PhD Julie Glavind

Aarhus University Hospital, Dep. Obstetrics and Gynecology, Aarhus, Denmark

Phone: +4578450000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place