Saint Louis, Missouri 63117

  • Central Blood Pressures

Purpose:

Plan to monitor central arterial pressure in women who are undergoing spinal anesthesia for cesarean delivery or epidural anesthesia for vaginal delivery.


Study summary:

Subjects will be screened as they are admitted to the maternity care floor (5th floor St. Mary's Hospital). Subjects will be approached if they are desiring regional anesthesia. The subject will have an additional blood pressure cuff placed on the arm that anesthesia is not using for their blood pressure cuff. Central arterial pressure will be measured from the cuff: - Prior to regional anesthesia placement - Every 15 minutes for 1 hour - Every 30 minutes for 2 hours Routine sphygmomanometer measurements will also completed at the above times. These are all study procedures. Anesthesia will use their usual protocol for blood pressure monitoring and management during placement of, and after the procedure. No changes in patient management will be made based upon the central arterial pressure as the guidelines were developed with routine brachial pressure.


Criteria:

Inclusion Criteria: - Singleton pregnancy - Planned regional anesthesia Exclusion Criteria: - Multiple pregnancy - Emergent cesarean delivery - Irregular heart rhythms or arrhythmias - Peripheral arterial disease, leg artery disease - Reynaud's phenomena - Intense cold/hypothermia - If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment - Severe tachycardia (>120) - Greater than 1st degree heart block - Congestive heart failure or heart disease - Inability to adequately monitor BP - Use of magnesium sulfate


Study is Available At:


Original ID:

27440


NCT ID:

NCT02933541


Secondary ID:


Study Acronym:


Brief Title:

Central Arterial Pressure Changes With Use of Regional Anesthesia in Obstetric Patients


Official Title:

Central Arterial Pressure Changes With Use of Regional Anesthesia in Obstetric Patients


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

14 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Louis University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

1000


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Shohreh Jamalabadi-Majidi, MPH, DMD
314-977-7482
shohreh.jamalabadimajidi@health.slu.edu
Backup Contact:Katherine Mathews, MD
3149772083
kmathew6@slu.edu

Study Dates

Start Date:September 2016
Completion Date:September 2021
Completion Type:Anticipated
Primary Completion Date:September 2021
Primary Completion Type:Anticipated
Verification Date:July 2020
Last Changed Date:July 23, 2020
First Received Date:September 12, 2016

Study Outcomes

Outcome Type:Primary Outcome
Measure:Amount of change in central arterial pressure in obesity.
Time Frame:3 hours
Safety Issues:False
Description:To determine if women who are obese undergo a larger change in their central arterial pressure than is seen by routine brachial cuff assessment, and if this effect is dependent on the level of obesity.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Louis University

Samples and Retentions

Study Population: Women who are admitted to our obstetrics ward and are planning on receiving regional anesthesia will be approached.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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