When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• • Pregnant women with pre- or early pregnancy BMI ≥ 30 kg/m2

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet Juliane Marie Centre
RECRUITING
Copenhagen
Herlev Hospital
RECRUITING
Herlev
Gødstrup Regional Hospital
RECRUITING
Herning
North Zealand's Hospital
RECRUITING
Hillerød
Hvidovre Hospital
RECRUITING
Hvidovre
Kolding Hospital
RECRUITING
Kolding
Nykøbing Falster Hospital
RECRUITING
Nykøbing Falster
Odense University Hospital
RECRUITING
Odense
Randers Regional Hospital
RECRUITING
Randers
Zealand University Hospital
RECRUITING
Roskilde
Viborg Hospital
RECRUITING
Viborg
Contact Information
Primary
Lise Q Krogh, MD
lise.qvirin.krogh@clin.au.dk
0045 51242102
Time Frame
Start Date: 2020-10-19
Estimated Completion Date: 2026-06
Participants
Target number of participants: 1900
Treatments
Experimental: Elective induction of labour
Elective induction of labour at 39 gestational weeks and 0 to 3 days.
No_intervention: Expectant management
Awaiting spontaneous labor.
Related Therapeutic Areas
Sponsors
Collaborators: Nykøbing Falster County Hospital, Central Jutland Regional Hospital, Herning Hospital, Kolding Sygehus, North Zealand's Hospital, Odense University Hospital, Randers Regional Hospital, Rigshospitalet Juliane Marie Centret, Zealand University Hospital - Roskilde, Herlev Hospital, Hvidovre University Hospital, Aarhus University Hospital
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov