- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464669
Impacts of Online and Group Perinatal Education
March 16, 2022 updated by: CHU de Quebec-Universite Laval
Impacts of Online and Group Perinatal Education: Towards and Optimization of Services
This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prenatal education is a core component of perinatal care and services provided by health institutions.
Whereas group prenatal education is the most common educational model, some health institutions have opted to implement online prenatal education to address accessibility issues as well as the evolving needs of future parents.
This prospective cohort study aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and the perinatal health status of parents.
It is part of a larger multipronged study using mixed methods.
Study Type
Observational
Enrollment (Actual)
1208
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Québec, Canada, G1L3L5
- CHU de Québec
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pregnant women and partners.
Recruitment methods :
- By the research team in hospital waiting rooms, before ultrasound appointments
- By health professionals in community centers during routine appointments
- Posters with the team's contact information
- Registration using advertisements on Facebook
Description
Inclusion Criteria for pregnant women:
- 10-20 weeks of pregnancy
- Living within the targeted geographic territories
- Fluent in French
- Have not given birth previously
Inclusion criteria for partners:
- Partner of pregnant women between 10 and 20 weeks of pregnancy
- Living within the targeted geographic territories
- Fluent in French
Exclusion Criteria:
- Men and women not fulfilling inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group prenatal education
Prenatal education delivered in-person by health and social services centers
|
Observational study : natural distribution of participants between groups
|
Online prenatal education
Online prenatal education provided or recommended by health and social services centers
|
Observational study : natural distribution of participants between groups
|
Control group
Absence of prenatal education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Perinatal Knowledge
Time Frame: 10-20 weeks of pregnancy; 33 weeks of pregnancy
|
Measured with an adapted version of the Health Pregnancies Knowledge Survey
|
10-20 weeks of pregnancy; 33 weeks of pregnancy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Psychological Distress
Time Frame: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Measured with a validated French version of the 12-item General Health Questionnaire
|
10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Change from Baseline Breastfeeding Self-Efficacy
Time Frame: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Assessed with a French version of the Breastfeeding Self-Efficacy Scale Short-Form
|
10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Change from Baseline Anxiety
Time Frame: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Assessed with a validated French version of the State-Trait Anxiety Inventory
|
10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Change from Baseline Self-Efficacy in the Parenting Role
Time Frame: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Assessed with a French version of the Parent Expectations Survey
|
10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Change from Baseline Depression
Time Frame: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Assessed with a French version of the Parent Expectations Survey
|
10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
|
Concern about Labour and Birth
Time Frame: 6 weeks after child birth
|
Assessed with a French version of the Oxford Worries about Labour Scale
|
6 weeks after child birth
|
Control during Childbirth
Time Frame: 6 weeks after child birth
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Assessed with a French version of the Labour Agentry Scale
|
6 weeks after child birth
|
Personal Control in Pain Relief during Childbirth
Time Frame: 6 weeks after child birth
|
Assessed with a French version of the Personal Control in Pain Relief Scale
|
6 weeks after child birth
|
Birth Weight
Time Frame: 6 weeks after child birth
|
Self-reported by parents
|
6 weeks after child birth
|
Personal experience of the COVID-19 crisis and its influence on the use of prenatal education and information services.
Time Frame: 33 weeks of pregnancy; 6 weeks after child birth
|
Measured by an in-house questionnaire put together by experts in perinatal care research and in the study of natural disasters and mental health.
|
33 weeks of pregnancy; 6 weeks after child birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2018
Primary Completion (Actual)
September 29, 2020
Study Completion (Actual)
September 29, 2020
Study Registration Dates
First Submitted
February 16, 2018
First Submitted That Met QC Criteria
March 7, 2018
First Posted (Actual)
March 14, 2018
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 16, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PHE-148163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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