Timing of Planned Caesarean Section and Morbidity of the Newborn

June 3, 2014 updated by: Julie Glavind, Aarhus University Hospital

Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1273

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aarhus University Hospital, Aalborg Hospital
      • Aarhus N, Denmark, 8200
        • Department of Obstetrics and Gynecology, Aarhus University Hospital Skejby
      • Herning, Denmark, 7400
        • Regional Hospital of Herning
      • Kolding, Denmark, 6000
        • Hospital of Kolding
      • Odense, Denmark, 5000
        • University Hospital of Odense
      • Randers, Denmark, 8930
        • Regional Hospital of Randers
      • Viborg, Denmark, 8800
        • Regional Hospital of Viborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Procedure: Elective caesarean section
Procedure performed at 39 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 38 weeks and 3 days of gestation (+/- 2 days)
Other Names:
  • Elective surgery
  • Planned caesarean section
Procedure: Elective caesarean section
Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)
Other Names:
  • Elective surgery
  • Planned caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal Admission After Elective Caesarean Section
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Neonatal Diagnoses
Time Frame: 30 days
30 days
Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics
Time Frame: 30 days
30 days
Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.
Time Frame: 30 days
30 days
Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission
Time Frame: 30 days
30 days
Maternal Satisfaction With Timing of Elective Caesarean Section
Time Frame: 2 months
2 months
Post Partum Depression
Time Frame: 2 months
2 months
Pediatric Admission and Morbidity
Time Frame: 2 months post partum
2 months post partum
Pediatric Admission and Morbidity
Time Frame: From birth until 2 years of age
From birth until 2 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (Estimate)

February 3, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAUH091077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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