About this trial
The rate of overweight and obese women becoming pregnant is increasing. Obesity in pregnancy along with delivery by cesarean section in obese women is associated with several complications as compared to normal weight women. The longer the woman is pregnant, the longer she is at risk. In an otherwise low-risk pregnant woman at term, it is an ongoing clinical dilemma, whether the benefits of elective induction of labor and termination of the pregnancy will outweigh the potential harms from concomitant induction and delivery process. The proposed study is a randomized controlled study of elective induction versus expectant management in obese women. The study will be carried out as a national multicenter study with inclusion of 1900 participants from Danish delivery wards. The null hypothesis is that the caesarean section rate is similar with elective induction of labor at 39 weeks of gestation, compared with expectant management among pregnant women with pre- or early pregnancy BMI≥30.
Eligibility criteria
Qualifiers
None
Disqualifiers
Legal or ethical considerations: maternal age <18 years, language difficulties requiring an interpreter or translator
Multiple pregnancy
Previous caesarean section
Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement
Trial design
Treatments tested in this trial
- Elective induction of labor at 39 gestational weeks and 0 to 3 days
Treatment groups
Locations
12Sponsors and collaborators
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Randers Regional Hospital
Collaborator
Herning Hospital
Collaborator
Central Jutland Regional Hospital
Collaborator
Nykøbing Falster County Hospital
Collaborator
Odense University Hospital
Collaborator
Rigshospitalet Juliane Marie Centret
Collaborator
Kolding Sygehus
Collaborator
Herlev Hospital
Collaborator
Hvidovre University Hospital
Collaborator
North Zealand's Hospital
Collaborator
Zealand University Hospital - Roskilde
Collaborator