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NCT Number: NCT00835003

Timing of Planned Caesarean Section and Morbidity of the Newborn

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.

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Key information

Conditions

Respiratory Disorders Intensive Care, Neonatal Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Odense, Odense, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

elective caesarean section

Procedure

Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)

Other names: Elective surgery, Planned caesarean section

Primary outcomes

  1. Neonatal Admission After Elective Caesarean Section

    Time frame: 48 hours

Secondary outcomes

  1. Neonatal Diagnoses

    Time frame: 30 days

  2. Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics

    Time frame: 30 days

  3. Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.

    Time frame: 30 days

  4. Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission

    Time frame: 30 days

  5. Maternal Satisfaction With Timing of Elective Caesarean Section

    Time frame: 2 months

  6. Post Partum Depression

    Time frame: 2 months

  7. Pediatric Admission and Morbidity

    Time frame: 2 months post partum

  8. Pediatric Admission and Morbidity

    Time frame: From birth until 2 years of age

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Feb 3, 2009
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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