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RecruitingNCT07320339Updated Jan 6, 2026

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

An interventional study of blood pressure measurement in Blood Pressure Measurement in Pregnancy, sponsored by Hillel Yaffe Medical Center. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Blood Pressure Measurement in Pregnancy
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women aged 18-40
  • Informed consent to participate.

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    variation in blood pressure between an optimal measurement and a 'common' measurement

    Procedure: blood pressure measurement

Interventions

  • Procedureblood pressure 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

05

What researchers measure

Primary outcomes

  1. Mean difference in systolic blood pressure (mmHg) between guideline-based and routine clinical measurement

    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: 1. guideline-based blood pressure measurement performed according to international hypertension guidelines (seated position, appropriate cuff size, arm supported at heart level after ≥5 minutes of rest), and 2. routine clinical blood pressure measurement as performed by nursing staff under usual clinical conditions. The primary outcome will be the within-participant mean difference in SBP (mmHg) between the two measurement methods.

    Time frame: 1 year

Secondary outcomes

  1. Mean difference in diastolic blood pressure (mmHg) between guideline-based and routine clinical measurement

    As above, for diastolic blood pressure (DBP).

    Time frame: 1 year

  2. Mean difference in mean arterial pressure (mmHg) between guideline-based and routine clinical measurement

    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

    Time frame: 1 yaer

06

Study locations

1 of 1 sites recruiting
  • Hille Yaffe Medical Center
    Hadera, Israel 3881000, Israel
    Recruiting
07

Registry details

Key details

Study ID
NCT07320339
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Jan 6, 2026
Start date
Aug 24, 2025
Primary completion
Aug 24, 2026 (estimated)
Completion
Aug 24, 2026 (estimated)
Last update
Jan 6, 2026

Study contacts

Ikhlas IM Ammash, M.D
Contact
AnnaTu@hymc.gov.il
+972-4-7744602

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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