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

Completed

• Conditions: Hypertension in Pregnancy; Pregnancy Related

• Registration Number: NCT05859282
• Lead Sponsor: Georges Hatem

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.

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 Timeline

• Study Start: 2021-11-07
• Primary Completion: 2022-02-27
• Study Completion: 2022-06-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-12
• Last Update Submitted: 2023-05-12
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Awareness of hypertensive disorders of pregnancy by developing a 25-item questionnaire	6 months	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.

Trial Locations

Locations (1)

Lebanese University Faculty of pharmacy; 🇱🇧 Beirut, Lebanon