|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02534051 |
|
Date of registration:
|
21/08/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Clinical Care Pathway for Obese Pregnant Women: A Pilot Cluster RCT
|
|
Scientific title:
|
A Clinical Care Pathway for Obese Pregnant Women: A Pilot Cluster Randomized Controlled Trial |
|
Date of first enrolment:
|
October 2015 |
|
Target sample size:
|
189 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02534051 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Participant).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Sarah D McDonald, MD, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
McMaster University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Inclusion criteria for clinics:
1. location in southwestern Ontario (for proximity to the research team),
2. availability of a clinician willing to serve as the local site lead, and
3. lack of any type of existing clinical care pathway for obese pregnant women
- Inclusion criteria for participants:
1. women with a pre-pregnancy (or in the event of inability to recall, then first
measured) BMI >30 kg/m2
2. with viable singleton pregnancies up to 20 weeks + 6 days gestational age upon
first visit to randomized clinic
Exclusion Criteria:
- Women with:
1. a miscarriage or termination of pregnancy after enrollment,
2. twins or higher order multiples or
3. a fetus with a known lethal anomaly.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Pregnancy
|
|
Obesity
|
|
Intervention(s)
|
|
Other: Clinical Care Pathway
|
|
Primary Outcome(s)
|
|
Feasibility (Rates)
[Time Frame: 10 months]
|
|
Secondary Outcome(s)
|
|
Provider outcomes - Questionnaire --Rates of
[Time Frame: 10 months]
|
|
Exploratory clinical outcomes - Rates of detection
[Time Frame: 10 months]
|
|
Process outcome - Rates of offer
[Time Frame: 10 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|