NCT05859282

Brief Summary

Background: Pregnancy-induced hypertension (PIH) is responsible for most perinatal and fetal mortality. Few programs are patient-centered during pregnancy, increasing the risks of misinformation and misconceptions among pregnant women and, as a result, malpractices. Objective: This study aims to develop and validate a form to assess the knowledge and attitudes of pregnant women about PIH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 4, 2023

Last Update Submit

May 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Awareness of hypertensive disorders of pregnancy by developing a 25-item questionnaire

    Thirty-six statements were initially provided to which women had to answer either ''yes'', ''No'' or ''I don't Know''. Out of these statements, 25 were retained due to positive inter-item correlation (15 knowledge statements and 10 behavior statements), and the other statements were eliminated one by one after testing for reliability and computing the effect of each statement on the internal consistency.

    6 months

Interventions

SurveyBEHAVIORAL

A short 25-item tool was developed and can be applied in clinics to assess the awareness of pregnancy hypertension.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women were targeted from five obstetrics and gynecology clinics.

You may qualify if:

  • Participants were asked to participate in the study with no criteria based on race, ethnicity, or gestational age.

You may not qualify if:

  • Those with a history of hypertension or pre-eclampsia were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lebanese University Faculty of pharmacy

Beirut, 0000, Lebanon

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Principal investigator

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 15, 2023

Study Start

November 7, 2021

Primary Completion

February 27, 2022

Study Completion

June 30, 2022

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations