Changes in Central Arterial Pressure When Comparing Nifedipine/Labetalol for Routine Hypertension Control in Pregnancy

November 8, 2017 updated by: Jennifer Goldkamp, MD, St. Louis University

Changes in Central Arterial Pressure When Comparing Nifedipine and Labetalol for Routine Hypertension Control in Pregnancy

To study central blood pressure changes caused by commonly used high blood pressure medications in pregnancy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Central blood pressures in addition to pulse wave velocity will be attained prior to medication, and then every 30 minutes for 4 hours (total of 9 readings). Sphygmomanometer readings will be completed at the same time (total readings 9). These readings are all related to the study.

Nursing will have the opportunity to to record the routine sphygmomanometer readings for their routine vitals if they chose to do so.

Their participation will be complete after the 4 hour assessment is complete.

Study Type

Observational

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

12 years to 48 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women in our clinics in addition to admitted to our antepartum units will be screened for inclusion criteria.

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol

Exclusion Criteria:

  • Multiple pregnancy
  • Currently on multiple anti-hypertension medications
  • Narcotic use
  • 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
  • Known sensitivity to labetalol or nifedipine
  • Severe tachycardia (>120)
  • Greater than 1st degree heart block
  • Severe asthma
  • Congestive heart failure or heart disease
  • Lupus
  • Inability to adequately monitor BP
  • Currently receiving magnesium sulfate

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nifedipine
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
Other: Nifedipine
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
Labetalol
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
Other: Labetalol
patients will be assigned to antihypertensive medications by their physicians in the course of their routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
central blood pressure changes
Time Frame: every 30 min for 4 hours
every 30 min for 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Louis University

Investigators

  • Principal Investigator: Jennifer Goldkamp, St. Louis University

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 (Anticipated)

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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