When to INDuce for OverWeight? (WINDOW)

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.

Conditions

• Pregnancy
• Obesity
• Parturition

Interventions

PROCEDURE

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

Elective induction of labor (eIOL) according to local policies

Sponsors & Collaborators

• University of Aarhus

  lead OTHER

• Aarhus University Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Central Jutland Regional Hospital

  collaborator OTHER

• Nykøbing Falster County Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Rigshospitalet Juliane Marie Centret

  collaborator UNKNOWN

• Kolding Sygehus

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• North Zealand's Hospital

  collaborator UNKNOWN

• Zealand University Hospital - Roskilde

  collaborator UNKNOWN

Principal Investigators

• Lise Q Krogh, MD · Aarhus University Hospital

• Julie Glavind, MD, PhD · Aarhus University Hospital

• Sidsel Boie, MD, PhD · Randers Regional Hospital

• Jens Fuglsang, MD, PhD · Aarhus University Hospital

• Tine B Henriksen, MD, PhD · Aarhus University Hospital

• Jim Thornton, MD, PhD · Nottingham University

• Katja A Taastrøm, Midwife, MSc · Aarhus University Hospital

• Anne Cathrine M Kjeldsen, Midwife, MSc · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-19

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Denmark

Study Locations