NCT03026010

Brief Summary

The aim of the study is to check standard screening blood pressure in the arm and central blood pressure, the blood pressure at the heart in pregnant women. The standard brachial pressure is routinely monitored throughout pregnancy, however it is not sensitive enough to distinguish preeclampsia from other types of hypertension or to predict preeclampsia in those at risk. Central aortic pressure monitoring has become a valuable clinical tool and preliminary studies suggest that measuring of central blood pressure may be better predictor of preeclampsia. It is non invasive and doesn't require undressing. It involves using a standard blood pressure cuff placed around the thigh, checking carotid pulse and pressure with an ultrasound and taking measurements of the person neck to torso. With this knowledge it will be a useful screening tool to identify these patients at higher risk and hopefully lead to closer monitoring, earlier treatment and reduced morbidity and mortality

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

January 12, 2017

Last Update Submit

November 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • pulse wave analysis

    pulse wave analysis can be a predictor of gestational hypertension/preeclampsia.

    1 year

Interventions

SphygmoCor XCEL will be used to measure both standard blood pressure in the arm and central pressure, the blood pressure at the heart.

Eligibility Criteria

Age14 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women \> or equal to 14 year old to 60 years old

You may qualify if:

  • ≤20 weeks pregnant

You may not qualify if:

  • Multi-pregnancy; Fetal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Laura Vricella, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 20, 2017

Study Start

November 1, 2016

Primary Completion

July 11, 2017

Study Completion

July 11, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share