When to INDuce for OverWeight? (WINDOW)
When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)
University of Aarhus
1,900 participants
Oct 19, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- Pregnant women with pre- or early pregnancy BMI ≥ 30 kg/m2
Exclusion Criteria9
- 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)
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Interventions
Elective induction of labor (eIOL) according to local policies
Locations(12)
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NCT04603859