A Clinical Care Pathway for Obese Pregnant Women: A Pilot Cluster RCT

NCT02534051 | Completed

• 1 other identifier: Carepath
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

Clinics will be randomized to the use of the care pathway for obese pregnant women or standard care. Women who are (1) up to 20 weeks + 6 days gestation into their pregnancy, (2) are carrying one baby (not twins) that is healthy (no life threatening anomalies) and (3) have a Body Mass Index ≥ 30 kg/m², will be included. Data will be obtained from the Ministry of Health's Antenatal Records, charts, and for those in the intervention group, the care path (filled out by the practitioners - the participants' obstetrician, midwife, or family doctor). At the end of the study, practitioners will complete a survey, participate in structured interviews to understand barriers, facilitators, and motivators of using the care path. Primary Objective: To evaluate the feasibility of implementing and testing a clinical care pathway for obese pregnant women in a pilot cluster randomized controlled trial (RCT) Secondary Objectives: To obtain pilot data on A) process outcomes (steps of the pathway, e.g. what % of obese women receive a screen for diabetes) B) clinical outcomes (e.g. what % of obese women receive a diagnosis of diabetes), C) provider outcomes (e.g. Is the intervention acceptable, feasible \& efficient? Barriers \& facilitators to use, effectiveness? \[Structured interviews\])

Conditions

Obesity; Pregnancy

Keywords

clinical care path; care pathway; obesity; pregnancy

Outcome Measures

Primary Outcomes (1)

• Feasibility (Rates)

  1. the feasibility of the intervention (defined as \>80%: A. compliance with each step in care path and B. clinicians recommend it.) 2. the feasibility of a cluster RCT (defined as \>80%: A. randomization (of approached clinics), B. uptake (of eligible women), C. completeness of follow-up.

  10 months

Secondary Outcomes (3)

• Process outcome - Rates of offer

  10 months

• Exploratory clinical outcomes - Rates of detection

  10 months

• Provider outcomes - Questionnaire --Rates of

  10 months

Study Arms (2)

Clinical care pathway

ACTIVE COMPARATOR

The intervention is the clinical care pathway designed by investigators, informed by the national guideline co-authored by one of the team, and supplemented by the review of the literature

Other: Clinical Care Pathway

Usual Care

NO INTERVENTION

The control group will receive the usual prenatal care.

Interventions

Clinical Care Pathway OTHER

The clinical care pathway guides aspects of care specific to obese pregnant women:1st trimester: offer of testing for pre-existing diabetes with either 75g OGTT or 50g GCT, nuchal translucency ultrasound (u/s), calculation of body mass index, counselling about weight gain, advising about medical complications, screening for obstructive sleep apnea, and referral to Maternal-Fetal Medicine if history of bariatric surgery, 2nd trimester: offer of maternal-serum alpha fetal protein (spina bifida), anatomy u/s, and 50g GCT and 75g OGTT, 3rd trimester: offer of consultation with anesthesiology, u/s for growth \& well-being, counselling about birth risks, and discussion of breastfeeding.

Clinical care pathway

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• location in southwestern Ontario (for proximity to the research team),
• availability of a clinician willing to serve as the local site lead, and
• lack of any type of existing clinical care pathway for obese pregnant women
• women with a pre-pregnancy (or in the event of inability to recall, then first measured) BMI \>30 kg/m2
• with viable singleton pregnancies up to 20 weeks + 6 days gestational age upon first visit to randomized clinic

You may not qualify if:

• Women with:
• a miscarriage or termination of pregnancy after enrollment,
• twins or higher order multiples or
• a fetus with a known lethal anomaly.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4K1, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah D McDonald, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 27, 2015
• Study Start: October 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

CA (1)