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

NCT ID: NCT02523781

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension, Pregnancy-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

The control group does not receive the information pamphlet

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

The intervention group receives the information pamphlet

Group Type EXPERIMENTAL

information pamphlet

Intervention Type OTHER

The intervention group receives the information pamphlet

Interventions

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information pamphlet

The intervention group receives the information pamphlet

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Nadine Sauvé

Researcher of the Mother-Child axis of the CRCHUS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sauvé Nadine, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Anne-Marie côté, MD

Role: STUDY_CHAIR

Université de Sherbrooke

Annabelle Cumyn, MD

Role: STUDY_CHAIR

Université de Sherbrooke

Marie-Eve Roy-Lacroix, MD

Role: STUDY_CHAIR

Université de Sherbrooke

Myriam Champagne, MD

Role: STUDY_CHAIR

Université de Sherbrooke

Marie-Hélène Pesant, MD

Role: STUDY_CHAIR

Université de Sherbrooke

Locations

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Centre Hopitalier Universiatire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2016-1099

Identifier Type: -

Identifier Source: org_study_id

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