RecruitingNot ApplicableNCT04603859

When to INDuce for OverWeight? (WINDOW)

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


Sponsor

University of Aarhus

Enrollment

1,900 participants

Start Date

Oct 19, 2020

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Elective induction of labor at 39 gestational weeks and 0 to 3 days for people with obesity, parturition, and other related conditions. The study is currently recruiting participants at 12 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREElective 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

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NCT04603859


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