The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity

NCT03985618 | Unknown DMC

• 2 other identifiers: CRRF ID 1469FDN148438
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of conducting a larger-scale trial (eligibility criteria)

  Appropriateness of eligibility criteria, measured by the reasons for exclusion of screened patients

  18 months

• Feasibility of conducting a larger-scale trial (recruitment rate)

  Eligibility and recruitment rate, measured by the proportion of patients who are eligible and recruited into the trial

  18 months

• Feasibility of conducting a larger-scale trial (randomization)

  Appropriateness of randomization, measured by the proportion of trial participants who consent to randomization

  18 months

Secondary Outcomes (7)

• Maternal morbidity and mortality

  Pregnancy to 6 week postpartum

• Fetal and neonatal morbidity and mortality

  Pregnancy to 6 week postpartum

• Length of hospital stay

  Start of induction to delivery; admission to delivery; and delivery until discharge, assessed up until 6-weeks postpartum

• Hospital readmission rates

  Delivery to 6-weeks postpartum

• Techniques for induction of labour

  Admission to hospital until delivery, assessed up to 7 days from hospital admission.

Study Arms (4)

Randomized Caesarean section

ACTIVE COMPARATOR

Randomized to planned pre-labour Caesarean section

Procedure: Caesarean section

Randomized Induction of Labour

ACTIVE COMPARATOR

Randomized to planned induction of labour

Procedure: Induction of Labour

Preference Caesarean section

ACTIVE COMPARATOR

Preference for planned pre-labour Caesarean section

Procedure: Caesarean section

Preference Induction of Labour

ACTIVE COMPARATOR

Preference for planned Induction of Labour

Procedure: Induction of Labour

Interventions

Caesarean section PROCEDURE

Planned pre-labour Caesarean section at 38-40 weeks. For patients planning Caesarean Section, surgical planning, precise timing and method of Caesarean section is at the discretion of the most responsible care provider, as per local procedures.

Also known as: C-section, Cesarean

Preference Caesarean section; Randomized Caesarean section

Induction of Labour PROCEDURE

Planned induction of labour at 38-40 weeks. For patients planning induction of labour, precise timing and method of induction of labour is at the discretion of the most responsible care provider, as per local procedures.

Preference Induction of Labour; Randomized Induction of Labour

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Cesarean Section; Labor, Induced

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Laura Gaudet, MD, MSc

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

• Ruth Rennicks White, BScN

  The Ottawa Hospital

  STUDY DIRECTOR

Central Study Contacts

Alysha LJ Harvey, MSc

CONTACT

6137378899; alyharvey@ohri.ca

Rosemary Larose, RPN

CONTACT

6137378899; rlarose@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 14, 2019
• Study Start: September 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2021
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)