When to INDuce for OverWeight? (WINDOW)

Recruiting now · Not applicable

Conditions studied: Pregnancy, Obesity, Parturition

In brief

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.

Key facts

Study ID

NCT04603859

Run by

University of Aarhus

People needed

1900

Starts

2020-10-19

Expected to finish

2026-07-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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 it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Rigshospitalet Juliane Marie Centre — Copenhagen, Denmark (enrolling)
• Herlev Hospital — Herlev, Denmark (enrolling)
• Gødstrup Regional Hospital — Herning, Denmark (enrolling)
• North Zealand's Hospital — Hillerød, Denmark (enrolling)
• Hvidovre Hospital — Hvidovre, Denmark (enrolling)
• Kolding Hospital — Kolding, Denmark (enrolling)
• Nykøbing Falster Hospital — Nykøbing Falster, Denmark (enrolling)
• Odense University Hospital — Odense, Denmark (enrolling)
• Randers Regional Hospital — Randers, Denmark (enrolling)
• Zealand University Hospital — Roskilde, Denmark (enrolling)
• Viborg Hospital — Viborg, Denmark (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.