Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603859
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2020-10-12
Brief Title:
When to INDuce for OverWeight WINDOW
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
When to INDuce for OverWeight - a Randomised Controlled Trial WINDOW
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WINDOW
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 BMI30
Detailed Description:
Background The World Health Organization WHO defines overweight as a body mass index BMI of 25 kgm2 and obesity as a BMI of 30 kgm2 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 kgm2 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 11 in the two following arms
Intervention armelective 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 armexpectant 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 womens 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 worlds 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
With this trial the investigators aim to compare the risk of caesarean section in obese BMI 30 kgm2 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 11 in the two following arms
Intervention armelective 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 armexpectant 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 womens 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 worlds 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None