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

NCT02523781 | Completed

• 1 other identifier: 2016-1099
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension, Pregnancy-Induced

Keywords

preeclampsia; information pamphlet; patient education

Outcome Measures

Primary Outcomes (1)

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

  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).

  4 weeks

Secondary Outcomes (11)

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

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

  4 weeks

Study Arms (2)

Control group

NO INTERVENTION

The control group does not receive the information pamphlet

Intervention group

EXPERIMENTAL

The intervention group receives the information pamphlet

Other: information pamphlet

Interventions

information pamphlet OTHER

The intervention group receives the information pamphlet

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not able to read and write in French.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hopitalier Universiatire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sauvé Nadine, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Anne-Marie côté, MD

  Université de Sherbrooke

  STUDY CHAIR

• Annabelle Cumyn, MD

  Université de Sherbrooke

  STUDY CHAIR

• Marie-Eve Roy-Lacroix, MD

  Université de Sherbrooke

  STUDY CHAIR

• Myriam Champagne, MD

  Université de Sherbrooke

  STUDY CHAIR

• Marie-Hélène Pesant, MD

  Université de Sherbrooke

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of the Mother-Child axis of the CRCHUS

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 14, 2015
• Study Start: June 1, 2015
• Primary Completion: August 20, 2017
• Study Completion: July 1, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)