Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

November 8, 2017 updated by: Jennifer Goldkamp, MD, St. Louis University
The investigators plan to monitor the central blood pressure in women with severely elevated blood pressures (160/110) in pregnancy in the acute setting. Currently ACOG recommends 3 different options for blood pressure control, however no one has studied how these medications affect the central pressures, only peripheral blood pressure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Women will be screened as they come in through the Women's Evaluation Unit or as transfers from outside hospitals to Labor & Delivery or the Perinatal Special Care Unit (PSCU). All women with severe hypertension (defined as 160/110 or above for 15 minutes or more) will be screened for inclusion and asked to participate in the study. If the woman agrees to participate she will be randomized to one of three groups with the following protocol:

Labetalol Administer 20mg IV labetalol Repeat BP in 10 minutes, if still severe administer 40mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 80mg IV Labetalol Repeat BP in 10 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, if still elevated consider ICU consult Hydralazine Administer 5mg IV hydralazine Repeat BP in 20 minutes, if still elevated administer 10mg IV Hydralazine Repeat BP in 20 minutes, still elevated administer labetalol 20mg IV Repeat BP in 10 minutes, still elevated administer labetalol 40mg IV and consider ICU consult Nifedipine Administer procardia 10mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer procardia 20mg po Repeat BP in 20 min, if still elevated administer labetalol 40mg IV and consider ICU consult

Administration of medication will be determined by the routine sphygmomanometer blood pressure as that is what the guidelines are based upon.

Women will then have their central arterial pressure and their carotid waveform assessed before administration of medication. The central pressure will be assessed every 5 minutes and carotid waveforms every 10 minutes until blood pressures are <160/110 for 20 minutes.

Administration of the above medications is standard of care. Randomization to different medications, measuring the central pressure and the carotid waveform is part of the study.

Once the patient's BP stays below 160/110 for 20 minutes their participation in the study will end.

Study Type

Interventional

Phase

  • Not Applicable

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

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women
  • Singleton pregnancy
  • Severe hypertension as defined by a blood pressure of 160/110 with plans to treat

Exclusion Criteria:

  • Multiple pregnancy
  • Blood pressures < 160/110, or those whose blood pressures do not require medication for control
  • 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, nifedipine, or hydralazine
  • Severe tachycardia (>120)
  • Greater than 1st degree heart block
  • Severe asthma
  • Congestive heart failure or heart disease
  • Lupus
  • Inability to adequately monitor BP
  • Inability to monitor fetus (if 23 weeks or above)
  • Magnesium started prior to initiation of study

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: labetalol
Drug: Labetalol
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Other Names:
  • Trandate®
Active Comparator: hydralazine
Hydralazine
Drug: Hydralazine
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Other Names:
  • Apresoline
Active Comparator: nifedipine
Drug: nifedipine
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Other Names:
  • Procardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication recommended by ACOG for severe hypertension
Time Frame: 20min from time of first normal blood pressure after intervention
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously
20min from time of first normal blood pressure after intervention

Collaborators and Investigators

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

Sponsor

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

August 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 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

  • 27295

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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