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

NCT02534051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2017-09-20

No results posted yet for this study

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

Interventions

OTHER

Clinical Care Pathway

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.

Sponsors & Collaborators

Principal Investigators

  • Sarah D McDonald, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Canada

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02534051 on ClinicalTrials.gov