Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension

Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension: A Cross-sectional Study Among Pregnant Women in Lebanon

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Hypertension in Pregnancy
• Intervention / Treatment: Behavioral: Survey

Detailed Description

Many observational studies explored the awareness of pregnant women of PIH, but no structured tool is available to assess such awareness. During the past two years, education campaigns were postponed and primary care was prioritized. To allow better-informed decisions and targeted actions, this pilot study aims to develop and validate a short form to assess the knowledge and attitudes of pregnant women about pregnancy-induced hypertension. The long-term objective of this study is to provide a practical tool for pregnant women.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 0000
    • Lebanese University Faculty of pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women were targeted from five obstetrics and gynecology clinics.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Georges Hatem

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2021
• Primary Completion (Actual): February 27, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 2D/21/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No