Evaluation of Educational Tools for Pregnant Women

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

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Other: Educational 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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hopitalier Universiatire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: educational tools; Subjects will receive at time 0 the educational tools (pamphlet-including a graphic-based summary, a magnet and a 12 minutes video). They will then have to answer a questionnaire 1 month later about knowledge, anxiety and satisfaction.	Other: Educational tools; 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
No Intervention: Usual antenatal care; Subjects in this group will not receive any more educational tools that what is generally offered in routine antenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge about preeclampsia	Through a questionnaire (7 questions, 35 statements, one global score)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Question 1: 8 statements (Likert's scale 1 to 6) Question 2 more general	1 month
Satisfaction	3 questions	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-group analysis: age	Diferences in outcomes between control and intervention groups according to group age	1 month
Sub-group analysis: parity	Differences between control and intervention group according to parity.	1 month
Sub-group analysis: pre-pregnancy BMI	Differences between control and intervention group according to pre-pregnancy BMI	1 month
Sub-group analysis: category of health care provider	Differences between control and intervention group according to category of healthcare provider	1 month
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
Sub-group analysis: tobacco use	Differences between control and intervention group according to tobacco use	1 month
Sub-group analysis:	Differences between control and intervention group according to employment type	1 month
Sub-group analysis: ethnicity	Differences between control and intervention group according to ethnicity	1 month
Sub-group analysis: socio-economic level	Differences between control and intervention group according to socio-economic level	1 month
Sub-group analysis: educational level	Differences between control and intervention group according to educational level	1 month
Sub-group analysis: marital status	Differences between control and intervention group according to marital status	1 month
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
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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Nadine Sauve, MD, Centre de recherche clinique of the Centre Hopitalier Universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Anxiety; Satisfaction; Patient education; Video; Preeclampsia; Knowledge; Pamphlet; Hypertensive disorders of pregnancy; Educationnal tools
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 13-025