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NCT04603859Completed

When to INDuce for OverWeight? (WINDOW)

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
1901 (actual)
First submitted
12 Oct 2020
Start date
19 Oct 2020
Primary completion date
10 Jul 2026
Lead sponsor
University of Aarhus
Diseases
Obesity
NCT number
NCT04603859

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1901
  • From 19 Oct 2020 to the primary completion date, 10 Jul 2026
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous caesarean section

Other illness

  • Fetal contraindications to IOL at time of randomisation: e.g. non-cephalic presentation, or other fetal conditions contraindicating vaginal delivery
  • Maternal contraindications to expectant management at time of randomisation: e.g. maternal medical conditions, ultrasonically diagnosed oligohydramnios (DVP\< 2 cm), signs of labour including pre-labour rupture of membranes (PROM)

Age

  • Legal or ethical considerations: maternal age \<18 years, language difficulties requiring an interpreter or translator
  • Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement

Other

  • Multiple pregnancy
  • Planned elective caesarean section at time of randomisation
  • Fetal contraindications to expectant management at time of randomisation
  • Maternal contraindications to IOL at time of randomisation: e.g. placenta previa/accreta, vasa previa

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus University Hospital
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AarhusDenmarkUnknown status
Rigshospitalet Juliane Marie Centre
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CopenhagenDenmarkUnknown status
Herlev Hospital
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HerlevDenmarkUnknown status
Gødstrup Regional Hospital
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HerningDenmarkUnknown status
North Zealand's Hospital
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HillerødDenmarkUnknown status
Hvidovre Hospital
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HvidovreDenmarkUnknown status
Kolding Hospital
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KoldingDenmarkUnknown status
Nykøbing Falster Hospital
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Nykøbing FalsterDenmarkUnknown status
Odense University Hospital
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OdenseDenmarkUnknown status
Randers Regional Hospital
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RandersDenmarkUnknown status
Zealand University Hospital
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RoskildeDenmarkUnknown status
Viborg Hospital
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ViborgDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.