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Completed

NCT Number: NCT01858324

Evaluation of Educational Tools for Pregnant Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hopitalier Universiatire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational tools

Other

Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.

Other names: Pamphlet (including a graphic-based summary), Magnet-summary, Video

Primary outcomes

  1. Knowledge about preeclampsia

    Time frame: 1 month

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

Secondary outcomes

  1. Anxiety

    Time frame: 1 month

    Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general

  2. Satisfaction

    Time frame: 1 month

    3 questions

Other outcomes

  1. Sub-group analysis: age

    Time frame: 1 month

    Diferences in outcomes between control and intervention groups according to group age

  2. Sub-group analysis: parity

    Time frame: 1 month

    Differences between control and intervention group according to parity.

  3. Sub-group analysis: pre-pregnancy BMI

    Time frame: 1 month

    Differences between control and intervention group according to pre-pregnancy BMI

  4. Sub-group analysis: category of health care provider

    Time frame: 1 month

    Differences between control and intervention group according to category of healthcare provider

  5. Sub-group analysis: preeclampsia risk factors

    Time frame: 1 month

    Differences between control and intervention group according to preeclampsia risk factors (pre-pregnancy diseases or a history of preeclampsia

  6. Sub-group analysis: tobacco use

    Time frame: 1 month

    Differences between control and intervention group according to tobacco use

  7. Sub-group analysis:

    Time frame: 1 month

    Differences between control and intervention group according to employment type

  8. Sub-group analysis: ethnicity

    Time frame: 1 month

    Differences between control and intervention group according to ethnicity

  9. Sub-group analysis: socio-economic level

    Time frame: 1 month

    Differences between control and intervention group according to socio-economic level

  10. Sub-group analysis: educational level

    Time frame: 1 month

    Differences between control and intervention group according to educational level

  11. Sub-group analysis: marital status

    Time frame: 1 month

    Differences between control and intervention group according to marital status

  12. Sub-group analysis:video viewed on site vs. at home

    Time frame: 1 month

    Differences between control and intervention group according to video viewed on-site vs. at home

  13. Sub-group analysis:delay since last consultation of the tools

    Time frame: 1 month

    Differences between control and intervention group according to delay since last consultation of the tools.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 21, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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