Development and Validation of a Short Tool to Assess the... | NCT05859282

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

NCT05859282

Sponsor

Georges Hatem

Status

Completed

Last Update Posted

May 15, 2023Actual

Enrollment

135Actual

Phase

Not provided

Conditions

Pregnancy Related
Hypertension in Pregnancy

Interventions

Survey

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2021Actual

Primary Completion Date

Feb 27, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

May 4, 2023

First Submission Date that Met QC Criteria

May 12, 2023

First Posted Date

May 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2023

Last Update Posted Date

May 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

135Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Behavioral	A short 25-item tool was developed and can be applied in clinics to assess the awareness of pregnancy hypertension.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant women were targeted from five obstetrics and gynecology clinics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lebanese University Faculty of pharmacy		Beirut		0000	Lebanon

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D006973	Hypertension

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided