- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320339
The Aim of the Study is to Examine the Variation in Blood Pressure Between an Optimal Measurement (According to Established Guidelines in the Literature - Per Guidelines) and a 'Common' Measurement (Used by Nursing Teams - Per Common Practice) Among Women of Reproductive Age With and Without Hyperte
December 21, 2025 updated by: Hillel Yaffe Medical Center
Standard vs. Routine Blood Pressure Measurement in Pregnancy: Effects of Position and Diurnal Variation
The aim of the study is to examine the variation in blood pressure between an optimal measurement (according to established guidelines in the literature - per guidelines) and a 'common' measurement (used by nursing teams - per common practice) among women of reproductive age with and without hyperte
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Accurate blood pressure measurement is a cornerstone of the diagnosis and management of hypertension.
The latest Clinical Practice Guidelines (AHA2020- International Society of Hypertension Global) emphasize several important steps for accurate blood pressure measurement, including choosing the correct cuff size, resting for five minutes, sitting with support for the back, feet flat on the floor, and legs uncrossed, and proper arm positioning (i.e., positioning the midpoint of the cuff at heart level with the arm supported on a table or work surface).
Sitting measurements are preferred because of the large amount of data linking blood pressure measurements in this position to health outcomes.
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ikhlas IM Ammash, M.D
- Phone Number: +972-4-7744602
- Email: AnnaTu@hymc.gov.il
Study Locations
-
-
Israel
-
Hadera, Israel, Israel, 3881000
- Recruiting
- Hille Yaffe Medical Center
-
Contact:
- Anna Turetzky, S.N
- Phone Number: +972-4-7744602
- Email: AnnaTu@hymc.go
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women aged 18-40
- Informed consent to participate.
Exclusion Criteria:
- Inability to cooperate with BP measurement under optimal conditions
- Women with complex underlying disease that may bias the data (e.g. significant vasculopathy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: variation in blood pressure between an optimal measurement and a 'common' measurement
|
examine the variation in blood pressure between an optimal measurement (according to established guidelines in the literature - per guidelines) and a 'common' measurement (used by nursing teams - per common practice) among women of reproductive age with and without hypertention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean difference in systolic blood pressure (mmHg) between guideline-based and routine clinical measurement
Time Frame: 1 year
|
Mean difference in systolic blood pressure (mmHg) between guideline-based and routine clinical measurement Description: Systolic blood pressure (SBP) will be measured in each participant using two methods:
The primary outcome will be the within-participant mean difference in SBP (mmHg) between the two measurement methods. |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean difference in diastolic blood pressure (mmHg) between guideline-based and routine clinical measurement
Time Frame: 1 year
|
As above, for diastolic blood pressure (DBP).
|
1 year
|
|
Mean difference in mean arterial pressure (mmHg) between guideline-based and routine clinical measurement
Time Frame: 1 yaer
|
Mean arterial pressure (MAP) will be calculated as MAP = (SBP + 2×DBP) / 3 for each measurement method.
The outcome will be the within-participant difference between methods
|
1 yaer
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2025
Primary Completion (Estimated)
August 24, 2026
Study Completion (Estimated)
August 24, 2026
Study Registration Dates
First Submitted
November 16, 2025
First Submitted That Met QC Criteria
December 21, 2025
First Posted (Actual)
January 6, 2026
Study Record Updates
Last Update Posted (Actual)
January 6, 2026
Last Update Submitted That Met QC Criteria
December 21, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 0111-25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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