Evaluation of Educational Tools for Pregnant Women

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858324
• Other study ID #: 13-025
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: December 2, 2014
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Ministère santé et services sociaux du Québec
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hopitalier Universiatire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sub-group analysis: age	Diferences in outcomes between control and intervention groups according to group age	1 month	No
Other	Sub-group analysis: parity	Differences between control and intervention group according to parity.	1 month	No
Other	Sub-group analysis: pre-pregnancy BMI	Differences between control and intervention group according to pre-pregnancy BMI	1 month	No
Other	Sub-group analysis: category of health care provider	Differences between control and intervention group according to category of healthcare provider	1 month	No
Other	Sub-group analysis: preeclampsia risk factors	Differences between control and intervention group according to preeclampsia risk factors (pre-pregnancy diseases or a history of preeclampsia	1 month	No
Other	Sub-group analysis: tobacco use	Differences between control and intervention group according to tobacco use	1 month	No
Other	Sub-group analysis:	Differences between control and intervention group according to employment type	1 month	No
Other	Sub-group analysis: ethnicity	Differences between control and intervention group according to ethnicity	1 month	No
Other	Sub-group analysis: socio-economic level	Differences between control and intervention group according to socio-economic level	1 month	No
Other	Sub-group analysis: educational level	Differences between control and intervention group according to educational level	1 month	No
Other	Sub-group analysis: marital status	Differences between control and intervention group according to marital status	1 month	No
Other	Sub-group analysis:video viewed on site vs. at home	Differences between control and intervention group according to video viewed on-site vs. at home	1 month	No
Other	Sub-group analysis:delay since last consultation of the tools	Differences between control and intervention group according to delay since last consultation of the tools.	1 month	No
Primary	Knowledge about preeclampsia	Through a questionnaire (7 questions, 35 statements, one global score)	1 month	No
Secondary	Anxiety	Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general	1 month	Yes
Secondary	Satisfaction	3 questions	1 month	No