Actively Recruiting
When to INDuce for OverWeight? (WINDOW)
Led by University of Aarhus · Updated on 2024-07-05
1900
Participants Needed
12
Research Sites
293 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
When to INDuce for OverWeight? (WINDOW)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with pre- or early pregnancy BMI 230 kg/m2
You will not qualify if you...
- Maternal age under 18 years
- Language difficulties requiring an interpreter or translator
- Multiple pregnancy
- Previous cesarean section
- Uncertain gestational age measured by methods other than Crown-Rump length (CRL)
- Planned elective cesarean section at time of randomization
- Fetal conditions preventing induction of labor, such as non-cephalic presentation or other contraindications to vaginal delivery
- Fetal conditions preventing expectant management
- Maternal conditions preventing induction of labor, such as placenta previa or vasa previa
- Maternal conditions preventing expectant management, including medical conditions, low amniotic fluid volume (deep vertical pocket less than 2 cm), or signs of labor including pre-labor rupture of membranes (PROM)
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
Rigshospitalet Juliane Marie Centre
Copenhagen, Denmark
Actively Recruiting
3
Herlev Hospital
Herlev, Denmark
Actively Recruiting
4
Gødstrup Regional Hospital
Herning, Denmark
Actively Recruiting
5
North Zealand's Hospital
Hillerød, Denmark
Actively Recruiting
6
Hvidovre Hospital
Hvidovre, Denmark
Actively Recruiting
7
Kolding Hospital
Kolding, Denmark
Actively Recruiting
8
Nykøbing Falster Hospital
Nykøbing Falster, Denmark
Actively Recruiting
9
Odense University Hospital
Odense, Denmark
Actively Recruiting
10
Randers Regional Hospital
Randers, Denmark
Actively Recruiting
11
Zealand University Hospital
Roskilde, Denmark
Actively Recruiting
12
Viborg Hospital
Viborg, Denmark
Actively Recruiting
Research Team
L
Lise Q Krogh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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