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Obesity Complicating ChildbirthMODENCT03985618

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

A study testing Caesarean section and Induction of Labour in people with Obesity Complicating Childbirth and Obesity, run by Ottawa Hospital Research Institute at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Caesarean section and Induction of Labour
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
1 Sep 2019to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Alysha LJ Harvey, MSc contact

6137378899 ext. 73838

alyharvey@ohri.ca

Rosemary Larose, RPN contact

6137378899 ext. 75866

rlarose@ohri.ca

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Alysha LJ Harvey, MSc, 613-737-8899 ext. 73838, alyharvey@ohri.ca

    Rosemary Larose, RPN, 613-737-8899 ext. 75866, rlarose@ohri.ca

Other trials in Canada

About this study

Official title: The MODE Trial: A Pilot Trial Investigating Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity

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.

Read the 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.

Being tested
Caesarean section, Induction of Labour
Keywords
obesity, pregnancy, labour, labor, caesarean, cesarean, C-section, induction
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caesarean sectionProcedure or surgery

    Also called C-section, Cesarean

    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.

  • Induction of LabourProcedure or surgery

    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.

Study groups in NCT03985618
Study groupRoleWhat they receive
Randomized Caesarean sectionActive comparatorRandomized to planned pre-labour Caesarean section
Receives: Procedure: Caesarean section
Randomized Induction of LabourActive comparatorRandomized to planned induction of labour
Receives: Procedure: Induction of Labour
Preference Caesarean sectionActive comparatorPreference for planned pre-labour Caesarean section
Receives: Procedure: Caesarean section
Preference Induction of LabourActive comparatorPreference for planned Induction of Labour
Receives: Procedure: Induction of Labour

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 18 months

  2. 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

    Measured: 18 months

  3. Feasibility of conducting a larger-scale trial (randomization)

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

    Measured: 18 months

Secondary outcomes (7)

  1. Maternal morbidity and mortality

    Rates of: maternal death, admission to ICU, intrapartum Caesarean section, postpartum hemorrhage, postpartum wound infection, endometritis, venous thromboembolism (VTE), hypertensive disorders of pregnancy (gestational hypertension or preeclampsia), indication for Caesarean delivery, operative vaginal delivery, indication for operative vaginal delivery, uterine incision extensions during Caesarean section, chorioamnionitis, third or fourth degree perineal lacerations, induction agents, pain medication use during induction, labour, Caesarean section and postpartum.

    Measured: Pregnancy to 6 week postpartum

  2. Fetal and neonatal morbidity and mortality

    Rates of: stillbirth, neonatal death, gestational age at birth, birthweight, need for respiratory support within 72 hours of birth, duration of respiratory support, 5 minute Apgar <7, hypoxic-ischemic encephalopathy, seizure, infection (confirmed sepsis or pneumonia), meconium aspiration syndrome, birth trauma (bone fracture, neurologic injury or retinal hemorrhage), cephalohematoma, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support, breastfeeding rates, hypoglycemia requiring intravenous treatment, jaundice requiring treatment, need for transfusion.

    Measured: Pregnancy to 6 week postpartum

  3. Length of hospital stay

    Length of hospital stay (in minutes) for both mom and baby

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

  4. Hospital readmission rates

    The proportion of mothers and/or infants re-admitted to the hospital

    Measured: Delivery to 6-weeks postpartum

  5. Techniques for induction of labour

    What method was used for induction

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

  6. Maternal satisfaction

    Maternal satisfaction with study design and procedures, measured by a survey

    Measured: Approximately 48-hours post-birth and 42+/-7 days postpartum

  7. Healthcare provider satisfaction

    Healthcare provider satisfaction with study design and procedures, measured through a survey

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start1 Sep 2019 (estimated)
  3. Primary completion31 Aug 2020 (estimated)
  4. Study completion31 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03985618
Sponsor's protocol ID
CRRF ID 1469
Other IDs
FDN148438
Acronym
MODE
Status last verified
Jun 2019
First submitted
21 May 2019
Last updated
14 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Caesarean section and Induction of Labour in people with Obesity Complicating Childbirth and Obesity, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alysha LJ Harvey, MSc (6137378899 ext. 73838, alyharvey@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of conducting a larger-scale trial (eligibility criteria) (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03985618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.

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