Elective induction of labor for obese pregnant women
When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)
This study is testing if starting labor early for obese pregnant women at 39 weeks can lead to fewer cesarean sections and complications compared to letting the pregnancy continue naturally.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1900 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 12 sites (Aarhus and 11 other locations) |
| Trial ID | NCT04603859 on ClinicalTrials.gov |
What this trial studies
This study investigates whether elective induction of labor at 39 weeks of gestation is more beneficial than expectant management for obese pregnant women with a BMI of 30 or higher. It aims to determine if elective induction can reduce the rate of cesarean sections and associated complications compared to allowing the pregnancy to continue. The study will involve a randomized controlled design with 1900 participants across multiple Danish delivery wards. The primary focus is on the safety and outcomes of both approaches in a low-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a pre- or early pregnancy BMI of 30 kg/m2 or higher.
Not a fit: Patients who may not benefit include those with multiple pregnancies, previous cesarean sections, or specific fetal or maternal contraindications.
Why it matters
Potential benefit: If successful, this study could lead to improved delivery outcomes and reduced cesarean section rates for obese pregnant women.
How similar studies have performed: Previous studies, such as the ARRIVE trial, have shown that elective induction can be beneficial in low-risk pregnancies, suggesting potential success for this approach in obese women.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Pregnant women with pre- or early pregnancy BMI ≥ 30 kg/m2 Exclusion Criteria: * Legal or ethical considerations: maternal age \<18 years, language difficulties requiring an interpreter or translator * Multiple pregnancy * Previous caesarean section * Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement * Planned elective caesarean section at time of randomisation * Fetal contraindications to IOL at time of randomisation: e.g. non-cephalic presentation, or other fetal conditions contraindicating vaginal delivery * Fetal contraindications to expectant management at time of randomisation * Maternal contraindications to IOL at time of randomisation: e.g. placenta previa/accreta, vasa previa * 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)
Where this trial is running
Aarhus and 11 other locations
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet Juliane Marie Centre — Copenhagen, Denmark (Recruiting)
- Herlev Hospital — Herlev, Denmark (Recruiting)
- Gødstrup Regional Hospital — Herning, Denmark (Recruiting)
- North Zealand's Hospital — Hillerød, Denmark (Recruiting)
- Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
- Kolding Hospital — Kolding, Denmark (Recruiting)
- Nykøbing Falster Hospital — Nykøbing Falster, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Randers Regional Hospital — Randers, Denmark (Recruiting)
- Zealand University Hospital — Roskilde, Denmark (Recruiting)
- Viborg Hospital — Viborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Lise Q Krogh, MD — Aarhus University Hospital
- Study coordinator: Lise Q Krogh, MD
- Email: lise.qvirin.krogh@clin.au.dk
- Phone: 0045 51242102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.