Pregnant Women and PartnersNCT03464669
Impacts of Online and Group Perinatal Education
An observational study of Pregnant Women and Partners, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women and Partners
- What is being tested?
- Prenatal education
- How many people
- 1,208 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jun 2018to 29 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 10-20 weeks of pregnancy
- Living within the targeted geographic territories
- Fluent in French
- Have not given birth previously
- Partner of pregnant women between 10 and 20 weeks of pregnancy
- Living within the targeted geographic territories
- Fluent in French
Who cannot join
- Men and women not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnant Women and Partners
- Being tested
- Prenatal education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal educationOther
Observational study : natural distribution of participants between groups
| Study group | Role | What they receive |
|---|---|---|
| Group prenatal education | Prenatal education delivered in-person by health and social services centers Receives: Other: Prenatal education | |
| Online prenatal education | Online prenatal education provided or recommended by health and social services centers Receives: Other: Prenatal education | |
| Control group | Absence of prenatal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Perinatal Knowledge
Measured with an adapted version of the Health Pregnancies Knowledge Survey
Measured: 10-20 weeks of pregnancy; 33 weeks of pregnancy
Secondary outcomes (10)
Change from Baseline Psychological Distress
Measured with a validated French version of the 12-item General Health Questionnaire
Measured: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
Change from Baseline Breastfeeding Self-Efficacy
Assessed with a French version of the Breastfeeding Self-Efficacy Scale Short-Form
Measured: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
Change from Baseline Anxiety
Assessed with a validated French version of the State-Trait Anxiety Inventory
Measured: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
Change from Baseline Self-Efficacy in the Parenting Role
Assessed with a French version of the Parent Expectations Survey
Measured: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
Change from Baseline Depression
Assessed with a French version of the Parent Expectations Survey
Measured: 10-20 weeks of pregnancy; 33 weeks of pregnancy; 6 weeks after child birth
Concern about Labour and Birth
Assessed with a French version of the Oxford Worries about Labour Scale
Measured: 6 weeks after child birth
Control during Childbirth
Assessed with a French version of the Labour Agentry Scale
Measured: 6 weeks after child birth
Personal Control in Pain Relief during Childbirth
Assessed with a French version of the Personal Control in Pain Relief Scale
Measured: 6 weeks after child birth
Birth Weight
Self-reported by parents
Measured: 6 weeks after child birth
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.
Measured: 33 weeks of pregnancy; 6 weeks after child birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start18 Jun 2018
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women and PartnersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464669
- Sponsor's protocol ID
- PHE-148163
- Status last verified
- Mar 2022
- First submitted
- 16 Feb 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Online and Group Perinatal Education: Towards and Optimization of Services
- ClinicalTrials.gov ID
- NCT03464669
- Acronym / sponsor ID
- PHE-148163
- Conditions
- Pregnant Women and Partners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group prenatal education | – | Other: Prenatal educationPrenatal education delivered in-person by health and social services centers |
| Online prenatal education | – | Other: Prenatal educationOnline prenatal education provided or recommended by health and social services centers |
| Control group | – | –Absence of prenatal education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 10-20 weeks of pregnancy
- Living within the targeted geographic territories
- Fluent in French
- Have not given birth previously
- Partner of pregnant women between 10 and 20 weeks of pregnancy
Key exclusion criteria (1 listed)
- Men and women not fulfilling inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal educationObservational study : natural distribution of participants between groups | Other | Group prenatal education, Online prenatal education |
Primary outcome
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 secondary outcomes
Change from Baseline Psychological Distress
Time frame: 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
Change from Baseline Anxiety
Time frame: 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
Change from Baseline Depression
Time frame: 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
Control during Childbirth
Time frame: 6 weeks after child birth
Personal Control in Pain Relief during Childbirth
Time frame: 6 weeks after child birth
Birth Weight
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Partners, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Perinatal Knowledge (time frame: 10-20 weeks of pregnancy; 33 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.