NCT04603859 When to INDuce for OverWeight? (WINDOW)
| NCT ID | NCT04603859 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2020-10-19 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,900 participants in total. It began in 2020-10-19 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Lise Q Krogh, MD
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT04603859 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04603859 currently recruiting?
Yes, NCT04603859 is actively recruiting participants. Contact the research team at lise.qvirin.krogh@clin.au.dk for enrollment information.
Where is the NCT04603859 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Copenhagen, Denmark, Herlev, Denmark, Herning, Denmark and 8 additional locations.
Who is sponsoring the NCT04603859 clinical trial?
NCT04603859 is sponsored by University of Aarhus. The principal investigator is Lise Q Krogh, MD at Aarhus University Hospital. The trial plans to enroll 1,900 participants.