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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet Juliane Marie Centre Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Gødstrup Regional Hospital Coordinator of this site? Confirm its status | Herning | Denmark | Unknown status |
| North Zealand's Hospital Coordinator of this site? Confirm its status | Hillerød | Denmark | Unknown status |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
| Kolding Hospital Coordinator of this site? Confirm its status | Kolding | Denmark | Unknown status |
| Nykøbing Falster Hospital Coordinator of this site? Confirm its status | Nykøbing Falster | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Randers Regional Hospital Coordinator of this site? Confirm its status | Randers | Denmark | Unknown status |
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
| Viborg Hospital Coordinator of this site? Confirm its status | Viborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.