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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Canada
      • Québec, Canada, G1L3L5
        • Chu De Quebec

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group prenatal education
Prenatal education delivered in-person by health and social services centers
Other: Prenatal education
Observational study : natural distribution of participants between groups
Online prenatal education
Online prenatal education provided or recommended by health and social services centers
Other: Prenatal education
Observational study : natural distribution of participants between groups
Control group
Absence of prenatal education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Quebec-Universite Laval

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fonds de la Recherche en Santé du Québec

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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