- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603859
When to INDuce for OverWeight? (WINDOW) (WINDOW)
When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background The World Health Organization (WHO) defines overweight as a body mass index (BMI) of ≥25 kg/m2 and obesity as a BMI of ≥30 kg/m2. Overweight and obesity are rising dramatically worldwide. In fertile women, the prevalence of obesity is one third in the United States, 20% in the United Kingdom, and 12-13% in Denmark. The association between obesity in pregnancy and the risk of gestational complications increases with increasing BMI. Among other complications, obesity in pregnancy is associated with increased risk of caesarean delivery. Delivery by caesarean section further adds significant risks of wound infection or other infectious morbidity in obese women as compared to normal weight women. The longer the woman is pregnant, the longer the risk of pregnancy complications remains. In an otherwise low-risk pregnant woman at term, it is an on-going clinical dilemma, whether the benefits of elective induction of labor (eIOL) and termination of the pregnancy will outweigh the potential harms from the concomitant induction and delivery process. Regarding delivery complications, based on data from historical cohorts, eIOL has traditionally been associated with an increased risk of caesarean section and instrumental delivery. Therefore, expectant management has been the preferred clinical option. This interpretation has now been challenged by a randomized trial (ARRIVE) with >6000 low-risk pregnant women where eIOL at 39 weeks of gestation was associated with lower caesarean delivery rates. There are no randomized studies in obese women, but two larger observational studies did find lower odds of caesarean delivery in obese women with eIOL as compared to awaiting labor onset. Hence, a randomized trial that would compare caesarean delivery among obese women whose labor is induced with those expectantly managed is warranted. The proposed study will provide new and important knowledge into the area of induction of labor among overweight and obese women with potential great international impact for the future raising number of pregnant women in this subgroup.
With this trial, the investigators aim to compare the risk of caesarean section in obese (BMI ≥ 30 kg/m2), but otherwise low-risk women with eIOL as compared to expectant management.
Materials and methods
The study is a multicenter randomized controlled trial with an allocation ratio of 1:1 in the two following arms:
- Intervention arm/elective induction of labor in pregnancy at 39 gestational week and 0 to 3 days: Induction is performed according to local policy for induction of labor.
Comparison arm/expectant management: Waiting for spontaneous onset of labor unless a situation develops necessitating either induction of labor or caesarean section.
1900 low-risk pregnant women with a pre- or early pregnancy BMI ≥ 30 carrying a singleton pregnancy will be recruited from the Danish delivery wards. In each trial site, a physician investigator will be responsible for the enrolment, the electronically randomization, and data collection.
The primary endpoint is the caesarean section rate. Among others there will be secondary endpoints on instrumental delivery, onset of labor, methods of induction, perinatal and postpartum complications both maternal and neonatal along with data on women's experience on birth measured by a questionnaire survey four to six weeks post-partum.
Ethics The study will be conducted in accordance with the ethical principles outlined in the latest version of the 'Declaration of Helsinki' and the 'Guideline for Good Clinical Practice' related to experiments on humans. The Central Denmark Region Committee on Biomedical Research Ethics, and The Danish Health Authorities have approved the study.
Perspectives In perspective, more than 39% of the world's population is overweight and 13% are obese by the WHO classification. Pregnant overweight women are at increased risk of pregnancy and delivery complications, and there is a need to improve maternity care for this subgroup of women. The results of this trial have the potential to generate important knowledge for the improvement of delivery in obese women and they will add key information to an on-going discussion of the effects of labor induction before term. Any possible harm or disadvantage to the individual study participant is outweighed by the possible benefit to the increasing number of obese women who will be pregnant in the future.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lise Q Krogh, MD
- Phone Number: 0045 51242102
- Email: lise.qvirin.krogh@clin.au.dk
Study Locations
-
-
-
Aarhus, Denmark
- Recruiting
- Aarhus University Hospital
-
Contact:
- Lise Q Krogh, MD
-
Herlev, Denmark
- Recruiting
- Herlev Hospital
-
Contact:
- Lene Huusom, MD, PhD
-
Herning, Denmark
- Recruiting
- Gødstrup Regional Hospital
-
Contact:
- Iben Sundtoft, MD, PhD
-
Hillerød, Denmark
- Recruiting
- North Zealand's Hospital
-
Contact:
- Hanne B Westergaard, MD, PhD
-
Hvidovre, Denmark
- Recruiting
- Hvidovre Hospital
-
Contact:
- Lone Krebs, MD, PhD
-
Kolding, Denmark
- Recruiting
- Kolding Hospital
-
Contact:
- Anne Cathrine H Munk, MD
-
København, Denmark
- Recruiting
- Rigshospitalet Juliane Marie Centre
-
Contact:
- Kristina Renault, MD, DMSc
-
Nykøbing Falster, Denmark
- Recruiting
- Nykøbing Falster Hospital
-
Contact:
- Jeannet Lauenborg, MD, PhD
-
Odense, Denmark
- Recruiting
- Odense University Hospital
-
Contact:
- Christina Vinter, MD, PhD
-
Randers, Denmark
- Recruiting
- Randers Regional Hospital
-
Contact:
- Pinar Bor, MD, PhD
-
Roskilde, Denmark
- Recruiting
- Zealand University Hospital
-
Contact:
- Nana Wiberg, MD
-
Viborg, Denmark
- Recruiting
- Viborg Hospital
-
Contact:
- Lise Clausen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elective induction of labour
Elective induction of labour at 39 gestational weeks and 0 to 3 days.
|
Elective induction of labor (eIOL) according to local policies
Other Names:
|
No Intervention: Expectant management
Awaiting spontaneous labor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caesarean section
Time Frame: At delivery
|
number (no.)
|
At delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mode of delivery if not by caesarean
Time Frame: At delivery
|
|
At delivery
|
Mode of delivery
Time Frame: At delivery
|
|
At delivery
|
Vaginal assisted delivery
Time Frame: At delivery
|
|
At delivery
|
Indication for caesarean section (more than one indication is possible)
Time Frame: At delivery
|
|
At delivery
|
Indication for vaginal assisted delivery (more than one is possible)
Time Frame: At delivery
|
|
At delivery
|
Use of epidural
Time Frame: At delivery
|
no.
|
At delivery
|
Damage to internal organs (bladder, bowel or ureters)
Time Frame: At delivery to 30 days postpartum
|
no.
|
At delivery to 30 days postpartum
|
Uterine scar dehiscense or rupture
Time Frame: At delivery
|
no.
|
At delivery
|
Complications
Time Frame: At delivery
|
|
At delivery
|
Postpartum haemorrhage
Time Frame: 0-2 hours postpartum
|
|
0-2 hours postpartum
|
Hysterectomy
Time Frame: At delivery to 30 days postpartum
|
no.
|
At delivery to 30 days postpartum
|
Postpartum morbidity
Time Frame: 0-30 days postpartum
|
|
0-30 days postpartum
|
Maternal admission to Intensive Care Unit
Time Frame: Enrollment to 30 days postpartum
|
no.
|
Enrollment to 30 days postpartum
|
Maternal cardiopulmonary arrest
Time Frame: Enrollment to 30 days postpartum
|
no.
|
Enrollment to 30 days postpartum
|
Maternal death
Time Frame: Enrollment to 30 days postpartum
|
no.
|
Enrollment to 30 days postpartum
|
Primary neonatal composite including any of the following;
Time Frame: Enrollment to 28 days of life
|
|
Enrollment to 28 days of life
|
Components of the primary neonatal composite will additionally be reported separately
Time Frame: Enrollment to 28 days of life
|
|
Enrollment to 28 days of life
|
Neonatal trauma composite including any of the following;
Time Frame: At delivery to 28 days of life
|
|
At delivery to 28 days of life
|
Neonatal asphyxia composite including any of the following;
Time Frame: At delivery to 28 days of life
|
|
At delivery to 28 days of life
|
Apgar score at 5 minutes
Time Frame: 5 minutes of life
|
|
5 minutes of life
|
Umbilical cord arterial and venous blood sample (allow missing data)
Time Frame: 0-30 minutes of life
|
|
0-30 minutes of life
|
Neonatal admission
Time Frame: 0-72 hours of life
|
no.
|
0-72 hours of life
|
Respiratory support during neonatal admission
Time Frame: 0-28 days of life
|
|
0-28 days of life
|
Other treatment during neonatal admission
Time Frame: 0-28 days of life
|
|
0-28 days of life
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal characteristics 1
Time Frame: At delivery
|
|
At delivery
|
Neonatal characteristics 2
Time Frame: At delivery
|
- Mean birth weight - grams
|
At delivery
|
Maternal experience on birth
Time Frame: 4-6 weeks postpartum
|
Childbirth Experience Questionnaire Scoring range is 1 to 4 where higher ratings reflect more positive experiences
|
4-6 weeks postpartum
|
Maternal postnatal depression
Time Frame: 4-6 weeks postpartum
|
|
4-6 weeks postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lise Q Krogh, MD, Aarhus University Hospital
- Study Chair: Julie Glavind, MD, PhD, Aarhus University Hospital
- Study Chair: Sidsel Boie, MD, PhD, Randers Regional Hospital
- Study Chair: Jens Fuglsang, MD, PhD, Aarhus University Hospital
- Study Chair: Tine B Henriksen, MD, PhD, Aarhus University Hospital
- Study Chair: Jim Thornton, MD, PhD, Nottingham University
- Study Chair: Katja A Taastrøm, Midwife, MSc, Aarhus University Hospital
- Study Chair: Anne Cathrine M Kjeldsen, Midwife, MSc, Aarhus University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WINDOW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The final dataset will be publicly available in an anonymised form using an open data repository (i.e. CERN) or another equivalent database.
All relevant trial-related documents will be shared along with the data.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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