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
Standard vs. Routine Blood Pressure Measurement in Pregnancy: Effects of Position and Diurnal Variation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 0111-25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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