Preeclampsia Clinical Trial
Official title:
Evaluation of Educational Tools Concerning Hypertension in Ambulatory Pregnant Women, Compared With Usual Antenatal Care
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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