When to INDuce for OverWeight? (WINDOW)

Launched by UNIVERSITY OF AARHUS · Oct 20, 2020

Keywords

ClinConnect Summary

The "When to INDuce for OverWeight?" (WINDOW) trial is studying the best way to manage labor for pregnant women who are overweight or obese. The researchers want to find out if inducing labor at 39 weeks of pregnancy can lead to a similar rate of cesarean sections compared to letting the pregnancy continue until natural labor starts. This is important because women with obesity may face more complications during pregnancy and delivery. The study will involve around 1,900 participants from delivery wards in Denmark.

To be eligible for this trial, women must be pregnant and have a body mass index (BMI) of 30 or higher before or early in their pregnancy. However, certain women will not be able to participate, such as those under 18, those who are having twins or more, or those with specific medical concerns that could affect delivery. Participants will be randomly assigned to either have their labor induced or to wait for natural labor. This trial aims to help doctors make better decisions about labor management for overweight pregnant women, ultimately improving outcomes for both mothers and babies.

Gender

FEMALE

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)