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RECRUITING
NCT04603859
NA

When to INDuce for OverWeight? (WINDOW)

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1900

Start Date

2020-10-19

Completion Date

2026-06

Last Updated

2024-07-05

Healthy Volunteers

Yes

Interventions

PROCEDURE

Elective induction of labor at 39 gestational weeks and 0 to 3 days

Elective induction of labor (eIOL) according to local policies

Locations (12)

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet Juliane Marie Centre

Copenhagen, Denmark

Herlev Hospital

Herlev, Denmark

Gødstrup Regional Hospital

Herning, Denmark

North Zealand's Hospital

Hillerød, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Kolding Hospital

Kolding, Denmark

Nykøbing Falster Hospital

Nykøbing Falster, Denmark

Odense University Hospital

Odense, Denmark

Randers Regional Hospital

Randers, Denmark

Zealand University Hospital

Roskilde, Denmark

Viborg Hospital

Viborg, Denmark