The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obe… (NCT03985618) | Clinical Trial Compass
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The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity
Canada100 participantsStarted 2019-09-01
Plain-language summary
Canadian guidelines recommend that women with a pre-pregnancy body mass index (BMI) at or above 40 kg/m2 deliver by their due date. When delivery is planned prior to spontaneous labour, there are two options: planned induction of labour or pre-labour Caesarean (C-section). However, it is not yet clear whether induction of labour or planned pre-labour C-section is the best option for this population.
The MODE Trial aims to assess the feasibility of conducting a larger-scale trial of planned mode of delivery in first time mothers who have a BMI \>=40kg/m2, and obtain preliminary data on health outcomes for moms and babies following delivery by either planned C-section or induction of labour.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Capability of participant to comprehend and comply with study requirements
* Age ≥18 years at time of consent
* Nulliparous (never given birth after 19+6/7 weeks of gestation)
* Pre-pregnancy BMI or calculated BMI obtained in the first 13 weeks of pregnancy ≥40kg/ m2
* Participant plans to give birth in a participating site
* Gestational age 34+0/7 - 36+6/7 weeks (based on estimated date of conception (EDC) assigned at the first ultrasound performed after 7+0/7 and prior to 20 +0/7 weeks)
* Live fetus, documented positive heart rate at visit 1 prior to randomization
* Singleton fetus in cephalic presentation at the time of randomization
* No maternal or fetal contraindications to vaginal delivery
Exclusion Criteria:
* Known major fetal anomaly, confirmed by ultrasound or genetic testing
* Multiple gestation
* Known documented evidence of alcohol or drug abuse in this current pregnancy
* Currently enrolled or has participated in another clinical trial within 3 months of the date of randomization (at discretion of Trial Coordinating Centre)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of conducting a larger-scale trial (eligibility criteria)
Timeframe: 18 months
2
Feasibility of conducting a larger-scale trial (recruitment rate)
Timeframe: 18 months
3
Feasibility of conducting a larger-scale trial (randomization)