Clinical trial NCT01858324: Evaluation of Educational Tools for Pregnant Women
Official title: Evaluation of Educational Tools Concerning Hypertension in Ambulatory Pregnant Women, Compared With Usual Antenatal Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Keywords: Preeclampsia
Hypertensive disorders of pregnancy
Patient education
Educationnal tools
Pamphlet
Video
Knowledge
Anxiety
Satisfaction
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 247
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge about preeclampsia
timeFrame: 1 month
Secondary outcomes:
measure: Anxiety
timeFrame: 1 month
measure: Satisfaction
timeFrame: 1 month
Other outcomes:
measure: Sub-group analysis: age
timeFrame: 1 month
measure: Sub-group analysis: parity
timeFrame: 1 month
measure: Sub-group analysis: pre-pregnancy BMI
timeFrame: 1 month
measure: Sub-group analysis: category of health care provider
timeFrame: 1 month
measure: Sub-group analysis: preeclampsia risk factors
timeFrame: 1 month
measure: Sub-group analysis: tobacco use
timeFrame: 1 month
measure: Sub-group analysis:
timeFrame: 1 month
measure: Sub-group analysis: ethnicity
timeFrame: 1 month
measure: Sub-group analysis: socio-economic level
timeFrame: 1 month
measure: Sub-group analysis: educational level
timeFrame: 1 month
measure: Sub-group analysis: marital status
timeFrame: 1 month
measure: Sub-group analysis:video viewed on site vs. at home
timeFrame: 1 month
measure: Sub-group analysis:delay since last consultation of the tools
timeFrame: 1 month
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hopitalier Universiatire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche clinique of the Centre Hopitalier Universitaire de Sherbrooke
name: Nadine Sauve, MD
role: PRINCIPAL_INVESTIGATOR
References: