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临床试验/NCT01858324
NCT01858324已完成不适用

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

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
247
试验地点
2
主要终点
Knowledge about preeclampsia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Consideration of an interruption of pregnancy for maternal or fetal reasons
  • Anticipated delivery within the next month.

结局指标

主要结局

Knowledge about preeclampsia

时间窗: 1 month

Through a questionnaire (7 questions, 35 statements, one global score)

次要结局

  • Anxiety(1 month)
  • Satisfaction(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadine Sauvé

Member of the Mother & Child Research Axis of the clinical research center Etienne Le Bel

Université de Sherbrooke

研究点 (2)

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