NCT01858324

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

May 14, 2013

Last Update Submit

December 2, 2014

Conditions

Preeclampsia

Keywords

PreeclampsiaHypertensive disorders of pregnancyPatient educationEducationnal toolsPamphletVideoKnowledgeAnxietySatisfaction

Outcome Measures

Primary Outcomes (1)

  • Knowledge about preeclampsia

    Through a questionnaire (7 questions, 35 statements, one global score)

    1 month

Secondary Outcomes (2)

  • Anxiety

    1 month

  • Satisfaction

    1 month

Other Outcomes (13)

  • Sub-group analysis: age

    1 month

  • Sub-group analysis: parity

    1 month

  • Sub-group analysis: pre-pregnancy BMI

    1 month

  • +10 more other outcomes

Study Arms (2)

educational tools

EXPERIMENTAL

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

Usual antenatal care

NO INTERVENTION

Subjects in this group will not receive any more educational tools that what is generally offered in routine antenatal care.

Interventions

Educational toolsOTHER

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

Also known as: Pamphlet (including a graphic-based summary), Magnet-summary, Video
educational tools

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Consideration of an interruption of pregnancy for maternal or fetal reasons
  • Anticipated delivery within the next month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hopitalier Universiatire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Pre-EclampsiaAnxiety DisordersPersonal Satisfaction

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Nadine Sauve, MD

    Centre de recherche clinique of the Centre Hopitalier Universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member of the Mother & Child Research Axis of the clinical research center Etienne Le Bel

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 21, 2013

Study Start

March 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

CA(1)