When to INDuce for OverWeight? (WINDOW)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Aarhus

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

1,900 Participants
are divided into 2 treatment groups

Locations

12
Aarhus University Hospital Aarhus Denmark
Rigshospitalet Juliane Marie Centre Copenhagen Denmark
Herlev Hospital Herlev Denmark
Gødstrup Regional Hospital Herning Denmark

Sponsors 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