Evaluation of Educational Tools for Pregnant Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Educational Tools Concerning Hypertension in Ambulatory Pregnant Women, Compared With Usual Antenatal Care

Conditions
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Preeclampsia

Intervention / Treatment
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* Other: Educational tools


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: educational tools<br>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. | Other: Educational tools<br>* Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.<br>* Other names: Video;|
| No Intervention: Usual antenatal care<br>Subjects in this group will not receive any more educational tools that what is generally offered in routine antenatal care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge about preeclampsia | Through a questionnaire (7 questions, 35 statements, one global score) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general | 1 month | 
| Satisfaction | 3 questions | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, Hypertensive disorders of pregnancy, Patient education, Educationnal tools, Pamphlet, Video, Knowledge, Anxiety, Satisfaction