Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
247 participants
INTERVENTIONAL
2014-03-31
2014-09-30
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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educational tools
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.
Educational tools
Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.
Usual antenatal care
Subjects in this group will not receive any more educational tools that what is generally offered in routine antenatal care.
No interventions assigned to this group
Interventions
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Educational tools
Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Anticipated delivery within the next month.
18 Years
FEMALE
No
Sponsors
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Université de Sherbrooke
OTHER
Responsible Party
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Nadine Sauvé
Member of the Mother & Child Research Axis of the clinical research center Etienne Le Bel
Principal Investigators
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Nadine Sauve, MD
Role: PRINCIPAL_INVESTIGATOR
Centre de recherche clinique of the Centre Hopitalier Universitaire de Sherbrooke
Locations
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Centre Hopitalier Universiatire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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13-025
Identifier Type: -
Identifier Source: org_study_id