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| ID | Type | Description | Link |
|---|---|---|---|
| FDN148438 | Other Grant/Funding Number | Canadian Institutes of Health Research |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Caesarean section | Active Comparator | Randomized to planned pre-labour Caesarean section |
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| Randomized Induction of Labour | Active Comparator | Randomized to planned induction of labour |
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| Preference Caesarean section | Active Comparator | Preference for planned pre-labour Caesarean section |
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| Preference Induction of Labour | Active Comparator | Preference for planned Induction of Labour |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alysha LJ Harvey, MSc | Contact | 6137378899 | 73838 | alyharvey@ohri.ca |
| Rosemary Larose, RPN | Contact | 6137378899 | 75866 | rlarose@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Laura Gaudet, MD, MSc | The Ottawa Hospital | Principal Investigator |
| Ruth Rennicks White, BScN | The Ottawa Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
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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.
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| 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. |
|
| Pregnancy to 6 week postpartum |
| 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. | Pregnancy to 6 week postpartum |
| Length of hospital stay | Length of hospital stay (in minutes) for both mom and baby | Start of induction to delivery; admission to delivery; and delivery until discharge, assessed up until 6-weeks postpartum |
| Hospital readmission rates | The proportion of mothers and/or infants re-admitted to the hospital | Delivery to 6-weeks postpartum |
| Techniques for induction of labour | What method was used for induction | Admission to hospital until delivery, assessed up to 7 days from hospital admission. |
| Maternal satisfaction | Maternal satisfaction with study design and procedures, measured by a survey | Approximately 48-hours post-birth and 42+/-7 days postpartum |
| Healthcare provider satisfaction | Healthcare provider satisfaction with study design and procedures, measured through a survey | 18 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| D007751 | Labor, Induced |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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