Evaluation of Educational Tools for Pregnant Women
Primary Purpose
Preeclampsia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational tools
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring Preeclampsia, Hypertensive disorders of pregnancy, Patient education, Educationnal tools, Pamphlet, Video, Knowledge, Anxiety, Satisfaction
Eligibility Criteria
Inclusion Criteria:
- Women between 20+0 to 32+6 weeks pregnant
- Aged 18 years old or more
- Who present at the Blood Sampling in Pregnancy clinic
- With an adequate understanding of written and spoken French or English in order to read the pamphlet and fill out the self-administered questionnaire
Exclusion Criteria:
- Consideration of an interruption of pregnancy for maternal or fetal reasons
- Anticipated delivery within the next month.
Sites / Locations
- Centre Hopitalier Universiatire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
educational tools
Usual antenatal care
Arm Description
Subjects will receive at time 0 the educational tools (pamphlet-including a graphic-based summary, a magnet and a 12 minutes video). They will then have to answer a questionnaire 1 month later about knowledge, anxiety and satisfaction.
Subjects in this group will not receive any more educational tools that what is generally offered in routine antenatal care.
Outcomes
Primary Outcome Measures
Knowledge about preeclampsia
Through a questionnaire (7 questions, 35 statements, one global score)
Secondary Outcome Measures
Anxiety
Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general
Satisfaction
3 questions
Full Information
NCT ID
NCT01858324
First Posted
May 14, 2013
Last Updated
December 2, 2014
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT01858324
Brief Title
Evaluation of Educational Tools for Pregnant Women
Official Title
Evaluation of Educational Tools Concerning Hypertension in Ambulatory Pregnant Women, Compared With Usual Antenatal Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypertensive disorders of pregnancy happen in 5% of pregnancies. Being aware of symptoms and complications may help women to present early and preserve their own and their baby's health.
The proposed research aims to evaluate the impact of educational tools in pregnant women from an ambulatory population. These tools include a detailed pamphlet (including a graphic-based summary), a magnet summarizing symptoms and appropriate action, and a video. Level of knowledge will be evaluated after one month with a validated questionnaire. We will also evaluate if getting more information about preeclampsia increases patient anxiety as well as satisfaction about the tools.
Detailed Description
Background: Preeclampsia is a leading cause of maternal/fetal morbidity/mortality. Pregnant women are often poorly informed on preeclampsia and seeking care too late results in maternal/fetal complications. Many healthcare providers believe that delivering information for low-risk women only make them more anxious.
Preliminary data: We published that an information pamphlet on preeclampsia increases knowledge, without increasing anxiety, and generates high satisfaction in women hospitalized for preeclampsia.
Objectives: Demonstrate that (1) ambulatory low-risk pregnant women will benefit from the pamphlet/video with improved knowledge; (2) without any increase in anxiety, and with great satisfaction.
Design: Prospective randomized controlled pilot study. Inclusion criteria: consecutive pregnant women aged ≥18 y.o. between 200-326 weeks presenting at the clinic and who read/write French or English. Exclusion criteria: Anticipated delivery or termination within one month. Intervention: pamphlet, magnet and video. Control: no educational tool. At baseline, women in both groups will answer questionnaire #1 on demographics; one month later: self-administered questionnaire #2 on knowledge, anxiety, satisfaction.
Sample size: N=178 will provide 80% power to find a significant improvement of at least 20% in knowledge score and 96% power to find a difference of at least 1 on scale for anxiety (alpha of 5%). Assuming a drop-out rate of 10%, missing answers <20%, and rate of answered questionnaire #2 of 50%, 400 subjects will be recruited.
Anticipated results: The tools will improve knowledge by about 20% in intervention group compared to control group. They will not increase anxiety over one point and will be highly appreciated by women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preeclampsia, Hypertensive disorders of pregnancy, Patient education, Educationnal tools, Pamphlet, Video, Knowledge, Anxiety, Satisfaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Arm Title
educational tools
Arm Type
Experimental
Arm Description
Subjects will receive at time 0 the educational tools (pamphlet-including a graphic-based summary, a magnet and a 12 minutes video). They will then have to answer a questionnaire 1 month later about knowledge, anxiety and satisfaction.
Arm Title
Usual antenatal care
Arm Type
No Intervention
Arm Description
Subjects in this group will not receive any more educational tools that what is generally offered in routine antenatal care.
Intervention Type
Other
Intervention Name(s)
Educational tools
Other Intervention Name(s)
Pamphlet (including a graphic-based summary), Magnet-summary, Video
Intervention Description
Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.
Primary Outcome Measure Information:
Title
Knowledge about preeclampsia
Description
Through a questionnaire (7 questions, 35 statements, one global score)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Anxiety
Description
Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general
Time Frame
1 month
Title
Satisfaction
Description
3 questions
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Sub-group analysis: age
Description
Diferences in outcomes between control and intervention groups according to group age
Time Frame
1 month
Title
Sub-group analysis: parity
Description
Differences between control and intervention group according to parity.
Time Frame
1 month
Title
Sub-group analysis: pre-pregnancy BMI
Description
Differences between control and intervention group according to pre-pregnancy BMI
Time Frame
1 month
Title
Sub-group analysis: category of health care provider
Description
Differences between control and intervention group according to category of healthcare provider
Time Frame
1 month
Title
Sub-group analysis: preeclampsia risk factors
Description
Differences between control and intervention group according to preeclampsia risk factors (pre-pregnancy diseases or a history of preeclampsia
Time Frame
1 month
Title
Sub-group analysis: tobacco use
Description
Differences between control and intervention group according to tobacco use
Time Frame
1 month
Title
Sub-group analysis:
Description
Differences between control and intervention group according to employment type
Time Frame
1 month
Title
Sub-group analysis: ethnicity
Description
Differences between control and intervention group according to ethnicity
Time Frame
1 month
Title
Sub-group analysis: socio-economic level
Description
Differences between control and intervention group according to socio-economic level
Time Frame
1 month
Title
Sub-group analysis: educational level
Description
Differences between control and intervention group according to educational level
Time Frame
1 month
Title
Sub-group analysis: marital status
Description
Differences between control and intervention group according to marital status
Time Frame
1 month
Title
Sub-group analysis:video viewed on site vs. at home
Description
Differences between control and intervention group according to video viewed on-site vs. at home
Time Frame
1 month
Title
Sub-group analysis:delay since last consultation of the tools
Description
Differences between control and intervention group according to delay since last consultation of the tools.
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women between 20+0 to 32+6 weeks pregnant
Aged 18 years old or more
Who present at the Blood Sampling in Pregnancy clinic
With an adequate understanding of written and spoken French or English in order to read the pamphlet and fill out the self-administered questionnaire
Exclusion Criteria:
Consideration of an interruption of pregnancy for maternal or fetal reasons
Anticipated delivery within the next month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Sauve, MD
Organizational Affiliation
Centre de recherche clinique of the Centre Hopitalier Universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hopitalier Universiatire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
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Evaluation of Educational Tools for Pregnant Women
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