Preeclampsia
Conditions
Keywords
Preeclampsia, Hypertensive disorders of pregnancy, Patient education, Educationnal tools, Pamphlet, Video, Knowledge, Anxiety, Satisfaction
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.
Interventions
OTHEREducational tools
Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge about preeclampsia | 1 month | Through a questionnaire (7 questions, 35 statements, one global score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 1 month | Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general |
| Satisfaction | 1 month | 3 questions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sub-group analysis: category of health care provider | 1 month | Differences between control and intervention group according to category of healthcare provider |
| Sub-group analysis: preeclampsia risk factors | 1 month | Differences between control and intervention group according to preeclampsia risk factors (pre-pregnancy diseases or a history of preeclampsia |
| Sub-group analysis: tobacco use | 1 month | Differences between control and intervention group according to tobacco use |
| Sub-group analysis: | 1 month | Differences between control and intervention group according to employment type |
| Sub-group analysis: ethnicity | 1 month | Differences between control and intervention group according to ethnicity |
| Sub-group analysis: age | 1 month | Diferences in outcomes between control and intervention groups according to group age |
| Sub-group analysis: educational level | 1 month | Differences between control and intervention group according to educational level |
| Sub-group analysis: marital status | 1 month | Differences between control and intervention group according to marital status |
| Sub-group analysis:video viewed on site vs. at home | 1 month | Differences between control and intervention group according to video viewed on-site vs. at home |
| Sub-group analysis:delay since last consultation of the tools | 1 month | Differences between control and intervention group according to delay since last consultation of the tools. |
| Sub-group analysis: socio-economic level | 1 month | Differences between control and intervention group according to socio-economic level |
| Sub-group analysis: parity | 1 month | Differences between control and intervention group according to parity. |
| Sub-group analysis: pre-pregnancy BMI | 1 month | Differences between control and intervention group according to pre-pregnancy BMI |
Countries
Canada
Outcome results
None listed