Clinical trial NCT03985618: The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity
Official title: The MODE Trial: A Pilot Trial Investigating Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity Complicating Childbirth
Obesity
Labor Onset and Length Abnormalities
Pregnancy, High Risk
Cesarean Section Complications
Keywords: obesity
pregnancy
labour
labor
caesarean
cesarean
C-section
induction
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-06-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Brewin partially randomized control trial, patient preference trial. In this design, each eligible patient is asked for her preference for mode of delivery. Patients with a preference are given their delivery mode of choice. If a patient does not have a preference, randomization takes place. Advantages to this design include the fact that preferences are taken into account in care allocation and that almost all those who are eligible enter the study.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Women with obesity have a decreased likelihood of achieving vaginal delivery. According to the Centre for Maternal and Child Enquiries, the chance of spontaneous vaginal delivery in women with a BMI ≥35kg/m2 is 55%, while the chance is 36.7% in women with a BMI ≥40.0kg/m2. This number includes women who go into labour spontaneously, in which, the odds of a vaginal delivery are highest. The rate of failure to induce labour approaches 80% with increased complications and morbidity including abnormal fetal heart rate monitoring, labour dystocia, emergency C-section, and fetal macrosomia. It has been proposed that some women may benefit from a planned Caesarean section delivery. However, Caesarean sections are also not straightforward in women with obesity, and come with significant risks of short- and long-term morbidity for mother and baby, including prolonged operative times, higher volumes of blood loss and infection rates and higher rates of NICU admission.

Given that there are many considerations when deciding how to best deliver a woman with obesity, it is not surprising that there is a high degree of clinical equipoise. In reality, the decision is made jointly between the patient and her care provider, often guided by overall instinct and local resource availability.

Studies to date have been retrospective in nature. There is a significant need for prospective study of the outcomes and experiences of planned induction of labour and planned Caesarean section in women with obesity to allow evidence-based counselling and decision-making.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of conducting a larger-scale trial (eligibility criteria)
timeFrame: 18 months
measure: Feasibility of conducting a larger-scale trial (recruitment rate)
timeFrame: 18 months
measure: Feasibility of conducting a larger-scale trial (randomization)
timeFrame: 18 months
Secondary outcomes:
measure: Maternal morbidity and mortality
timeFrame: Pregnancy to 6 week postpartum
measure: Fetal and neonatal morbidity and mortality
timeFrame: Pregnancy to 6 week postpartum
measure: Length of hospital stay
timeFrame: Start of induction to delivery; admission to delivery; and delivery until discharge, assessed up until 6-weeks postpartum
measure: Hospital readmission rates
timeFrame: Delivery to 6-weeks postpartum
measure: Techniques for induction of labour
timeFrame: Admission to hospital until delivery, assessed up to 7 days from hospital admission.
measure: Maternal satisfaction
timeFrame: Approximately 48-hours post-birth and 42+/-7 days postpartum
measure: Healthcare provider satisfaction
timeFrame: 18 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Laura Gaudet, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital
name: Ruth Rennicks White, BScN
role: STUDY_DIRECTOR
References: