When to INDuce for OverWeight? (WINDOW)
Recruiting · NCT04603859 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
12 locations listed.
- Aarhus University Hospital - Aarhus, Denmark
- Rigshospitalet Juliane Marie Centre - Copenhagen, Denmark
- Herlev Hospital - Herlev, Denmark
- Gødstrup Regional Hospital - Herning, Denmark
- North Zealand's Hospital - Hillerød, Denmark
- Hvidovre Hospital - Hvidovre, Denmark
- Kolding Hospital - Kolding, Denmark
- Nykøbing Falster Hospital - Nykøbing Falster, Denmark
- Odense University Hospital - Odense, Denmark
- Randers Regional Hospital - Randers, Denmark
- Zealand University Hospital - Roskilde, Denmark
- Viborg Hospital - Viborg, Denmark