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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05859282
• Other study ID #: 2D/21/10
• Status: Completed
• Start date: November 7, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: Lebanese University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 30, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
Lebanon	Lebanese University Faculty of pharmacy	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Georges Hatem

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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