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Completed

NCT Number: NCT02523781

Evaluation of an Information Pamphlet for Postpartum Women That Had a Hypertensive Pregnancy

It is known that preeclampsia is a risk factor for cardiovascular diseases, diabetes, chronic hypertension, nephropathy and thromboembolism. The study's aim, subsequent to these informations, is to help prevent those consequences. Information tools have been known to enhance retention of information given orally. The objective of this study is to assess the knowledge and satisfaction of women after an episode of preeclampsia after reading an explanatory pamphlet on preeclampsia. The investigators also want to change their perception on cardiovascular risk, their risk of recurrence and preeclampsia's medium to long-term consequences and the ways to prevent them.

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Key information

Conditions

Hypertension, Pregnancy-Induced Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

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

This is a randomised-controlled trial. Women recruted will first answer a questionnaire assessing demographic data, knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected.

Then, women in the intervention group will receive the pamphlet. One month after, women in both groups will receive a questionnaire similar to the first one assessing knowledge about risks in the future, perception of cardiovascular risk, anxiety about that risk and satisfaction about information received or collected, including the pamphlet for the intervention group.

The pamphlet was validated by a multidisciplany team including patients, doctors, nurses, education specialists and communication specialists.

The questionnaire was also validated by the same multidisciplinary team. Section on knowledge and anxiety were remodeled from previously validated questionnaires Section on perception of cardiovascular risk was reproduced and translated with permission from its author.

Section on satisfaction was reproduced from the investigators' previous study where it was validated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years and older
  • followed at the CHUS obstetrical clinic for a 4 weeks to 18 months postpartum follow up
  • had hypertension in her last pregnancy

Exclusion criteria

  • Not able to read and write in French.

Treatment and study plan

information pamphlet

Other

The intervention group receives the information pamphlet

Primary outcomes

  1. knowledge improvement (questionnaire with check list and true/false questions).

    Time frame: 4 weeks

    The primary outcome will be the comparison of knowledge between the intervention (with the pamphlet) and the control (without the pamphlet) group at one month with a validated questionnaire (knowledge: check list and true/false questions).

Secondary outcomes

  1. Perception of cardiovascular risk between the intervention and the control group at one month (Likert scale)

    Time frame: 4 weeks

    The comparison of perception of cardiovascular risk at one month between the intervention (with the pamphlet) and the control (without the pamphlet) group with a validated Likert scale included in the questionnaire.

  2. Anxiety between the intervention and the control group at one month.(Likert scale)

    Time frame: 4 weeks

    Comparison of anxiety at one month between the intervention and the control group with a validated Likert scale included in the questionnaire.

  3. Satisfaction between the intervention and the control group at one month.(Likert scale)

    Time frame: 4 weeks

    Comparison of satisfaction about all sources of information at one month between the intervention and the control group with a validated Likert scale included in the questionnaire.

  4. Perception of cardiovascular risk in the intervention group between baseline and at one month (Likert scale)

    Time frame: 4 weeks

    The comparison of perception of cardiovascular risk between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.

  5. Perception of cardiovascular risk between baseline and at one month in the control group. (Likert scale)

    Time frame: 4 weeks

    The comparison of perception of cardiovascular risk between baseline and at one month in the control group with a validated Likert scale included in the questionnaire.

  6. Anxiety in the intervention group between baseline and at one month (Likert scale)

    Time frame: 4 weeks

    The comparison of anxiety between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.

  7. Anxiety in the control group between baseline and at one month (Likert scale)

    Time frame: 4 weeks

    The comparison of anxiety between baseline and at one month in the control group with a validated Likert scale included in the questionnaire

  8. Satisfaction in the intervention group between baseline and at one month(Likert scale)

    Time frame: 4 weeks

    The comparison of satisfaction between baseline and at one month in the intervention group with a validated Likert scale included in the questionnaire.

  9. Satisfaction in the control group between baseline and at one month (Likert scale)

    Time frame: 4 weeks

    The comparison of satisfaction between baseline and at one month in the control group with a validated Likert scale included in the questionnaire.

  10. Knowledge in the intervention group between baseline and at one month (questionnaire with check list and true/false questions).

    Time frame: 4 weeks

    The comparison of baseline knowledge and knowledge at one month in the intervention group with a validated questionnaire (knowledge: check list and true/false questions).

  11. Knowledge in the control group between baseline and at one month (questionnaire with check list and true/false questions).

    Time frame: 4 weeks

    The comparison of Baseline knowledge and knowledge at one month in the control group with a validated questionnaire (knowledge: check list and true/false questions).

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Evaluation of an Information Pamphlet to Improve Knowledge Concerning the Impacts and the Importance of Healthy Lifestyle After a Pregnancy With Hypertension

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Aug 14, 2015
Registry last updated
Apr 27, 2021

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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