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. 2019 Sep 17;2019(9):CD012099. doi: 10.1002/14651858.CD012099.pub2

NCT02534051.

Trial name or title A clinical care pathway for obese pregnant women: a pilot cluster‐RCT
Methods RCT, parallel, with 1:1 allocation of clinics to provide the intervention care pathway or the standard care pathway for obese pregnant women
Participants 142 participants planned (189 recruited)
Setting: Canada
Inclusion criteria
Clinics

  1. Located in Southwestern Ontario

  2. Availability of a clinician willing to serve as local site lead

  3. Lack of an existing care pathway for obese pregnant women


Maternal

  1. Pre‐pregnancy BMI > 30 kg/m²

  2. Viable singleton pregnancy (no life‐threatening anomalies)

  3. Up to 20 weeks + 6 days' gestation into their pregnancy


Exclusion criteria:

  1. Miscarriage or termination after study enrolment

  2. Twins or higher order multiple

  3. A fetus with a known lethal anomaly
Interventions Intervention: care according to a care pathway with care specific to obese pregnant women, including fetal screening, maternal screening for diabetes, counselling about weight gain, counselling about birth risks and a discussion about breastfeeding
Control group: usual perinatal care
Outcomes Primary outcome measures

  1. The feasibility of the intervention (defined as > 80%: i) compliance with each step in care path and ii) clinicians recommend it.)

  2. The feasibility of a cluster‐RCT (defined as > 80%: i) randomisation (of approached clinics), ii) uptake (of eligible women) iii) completeness of follow‐up


Secondary outcome measures

  1. Trimester 1: rates of offer of testing for pre‐existing diabetes, nuchal translucency ultrasound, calculation of BMI, counselling about weight gain, advising about medical complications, screening for obstructive sleep apnoea, referral to maternal‐fetal medicine if history of bariatric surgery

  2. Trimester 2: offer of maternal‐serum alpha fetal protein testing for spina bifida, anatomy ultrasound, a glucose tolerance test

  3. Trimester 3: offer of consultation with anaesthesiology, ultrasound for growth and well‐being, counselling for risk of operative vaginal delivery, shoulder dystocia, caesarean section, and discussion of breastfeeding


Exploratory clinical outcomes:

  1. Rates of detection of fetal abnormalities: cardiac, neural tube or other defects

  2. Rate of detection of maternal outcomes: type 2 diabetes, gestational diabetes, sleep apnoea


Provider outcomes:

  1. Acceptability (defined as > 80% would recommend it to a colleague)

  2. Feasibility (defined as > 80% found it easily accomplished during routine care)

  3. Usefulness (defined as > 80% thought women more likely to receive appropriate care with it)

  4. Barriers and facilitators to the intervention; mechanisms or factors that impact its ease of use and effectiveness and for its improvement
Starting date October 2015
Contact information Sarah D McDonald, McMaster University
Notes