Timing of Planned Caesarean Section and Morbidity of the Newborn

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00835003
• Collaborator: (none)
• Enrollment: 1,273
• Locations: 7
• Arms: 2
• Duration (Months): 60
• Patients Per Site: 181.9
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Disorders; Intensive Care, Neonatal	Procedure: Elective caesarean section; Procedure: Elective caesarean section	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Elective caesarean section at 38 weeks and 3 days of gestation	Procedure: Elective caesarean section; Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days); Other Names: Elective surgery Planned caesarean section
Active Comparator: 2 Elective caesarean section at 39 weeks and 3 days of gestation	Procedure: Elective caesarean section; Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days); Other Names: Elective surgery Planned caesarean section

Outcome Measures

Primary Outcome Measures

1. Neonatal Admission After Elective Caesarean Section [48 hours]

Secondary Outcome Measures

1. Neonatal Diagnoses [30 days]

2. Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics [30 days]

3. Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section. [30 days]

4. Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission [30 days]

5. Maternal Satisfaction With Timing of Elective Caesarean Section [2 months]

6. Post Partum Depression [2 months]

7. Pediatric Admission and Morbidity [2 months post partum]

8. Pediatric Admission and Morbidity [From birth until 2 years of age]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective caesarean section

• Gestational age determined at 12 weeks ultrasound scan

• Singleton pregnancy

Exclusion Criteria:

• < 18 years of age (at time of randomization)

• In need of an interpreter to communicate in danish

• Diabetes, both gestational and before pregnancy

• A mother with an estimated high risk of caesarean section before 39+5 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital, Aalborg Hospital	Aalborg		Denmark	9000
2	Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby	Aarhus N		Denmark	8200
3	Regional Hospital of Herning	Herning		Denmark	7400
4	Hospital of Kolding	Kolding		Denmark	6000
5	University Hospital of Odense	Odense		Denmark	5000
6	Regional Hospital of Randers	Randers		Denmark	8930
7	Regional Hospital of Viborg	Viborg		Denmark	8800

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

• Principal Investigator: Julie Glavind, MD, Department of Gynecology and Obstetrics, Aarhus University Hospital Skejby
• Study Chair: Niels Uldbjerg, MD,Professor, Department og Gynecology and Obstetrics, Aarhus University Hospital Skejby
• Study Chair: Tine B Henriksen, MD, Professor, Neonatal Department, Aarhus University Hospital Skejby
• Study Chair: Sara F Kindberg, PhD, midwife, Perinatal Research Unit, Aarhus University Hospital Skejby

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julie Glavind, MD, PhD, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT00835003
• Other Study ID Numbers: AAUH091077
• First Posted: Feb 3, 2009
• Last Update Posted: Jul 3, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Julie Glavind, MD, PhD, Aarhus University Hospital: Neonatal admission; Elective Caesarean Section; Timing; Choice behavior; Intraoperative complications; Postoperative complications
• Additional relevant MeSH terms: Respiration Disorders; Respiratory Tract Diseases

Study Results

Participant Flow

Arm/Group Title	38 Weeks Group	39 Weeks Group
Arm/Group Description	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)	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)
Period Title: Overall Study
STARTED	636	638
COMPLETED	636	638
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	38 Weeks Group	39 Weeks Group	Total
Arm/Group Description	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)	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 of all reporting groups
Overall Participants	636	638	1274
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.1 (4.4)	31.6 (4.6)	31.8 (4.0)
Sex: Female, Male (Count of Participants)
Female	636 100%	638 100%	1274 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Denmark	636 100%	638 100%	1274 100%

Outcome Measures

1. Primary Outcome

Title	Neonatal Admission After Elective Caesarean Section
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	38 Weeks Group	39 Weeks Group
Arm/Group Description	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)	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)
Measure Participants	635	637
Number [participants]	88 13.8%	76 11.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	38 Weeks Group, 39 Weeks Group
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Neonatal Diagnoses
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Maternal Satisfaction With Timing of Elective Caesarean Section
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Post Partum Depression
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Pediatric Admission and Morbidity
Time Frame	2 months post partum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Pediatric Admission and Morbidity
Time Frame	From birth until 2 years of age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	30 days
Arm/Group Title	38 Weeks Group		39 Weeks Group
Arm/Group Description	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)		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)
All Cause Mortality
	38 Weeks Group		39 Weeks Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	38 Weeks Group		39 Weeks Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/636 (0.2%)		2/638 (0.3%)
Pregnancy, puerperium and perinatal conditions
Fetal death	1/636 (0.2%)		1/638 (0.2%)
Respiratory, thoracic and mediastinal disorders
Neonatal death	0/636 (0%)		1/638 (0.2%)
Other (Not Including Serious) Adverse Events
	38 Weeks Group		39 Weeks Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/636 (0%)		0/638 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.