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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03464669
Other study ID # PHE-148163
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 18, 2018
Est. completion date September 29, 2020

Study information

Verified date March 2022
Source CHU de Quebec-Universite Laval
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1208
Est. completion date September 29, 2020
Est. primary completion date September 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Prenatal education
Observational study : natural distribution of participants between groups

Locations

Country Name City State
Canada CHU de Québec Québec

Sponsors (2)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Perinatal Knowledge Measured with an adapted version of the Health Pregnancies Knowledge Survey 10-20 weeks of pregnancy; 33 weeks of pregnancy
Secondary Change from Baseline Psychological Distress 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
Secondary Change from Baseline Breastfeeding Self-Efficacy 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
Secondary Change from Baseline Anxiety 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
Secondary Change from Baseline Self-Efficacy in the Parenting Role Assessed with a French version of the Parent Expectations Survey 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
Secondary Change from Baseline Depression Assessed with a French version of the Parent Expectations Survey 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
Secondary Concern about Labour and Birth Assessed with a French version of the Oxford Worries about Labour Scale 6 weeks after child birth
Secondary Control during Childbirth Assessed with a French version of the Labour Agentry Scale 6 weeks after child birth
Secondary Personal Control in Pain Relief during Childbirth Assessed with a French version of the Personal Control in Pain Relief Scale 6 weeks after child birth
Secondary Birth Weight Self-reported by parents 6 weeks after child birth
Secondary Personal experience of the COVID-19 crisis and its influence on the use of prenatal education and information services. 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