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Clinical Trials in Denmark / NCT04603859
Recruiting Not applicable

When to INDuce for OverWeight? (WINDOW)

NCT04603859 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2020-10-19
Last updated
2026-06-26

Condition(s) studied

PregnancyObesityParturition

Investigational drug(s) / intervention(s)

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

Elective induction of labor at 39 gestational weeks and 0 to 3 days: Elective induction of labor (eIOL) according to local policies

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
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

More University of Aarhus trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04603859 on ClinicalTrials.gov ↗ ← All trials in Denmark