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Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

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ClinicalTrials.gov Identifier: NCT02933593
Recruitment Status : Withdrawn (PI withdrew the protocol)
First Posted : October 14, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Goldkamp, MD, St. Louis University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Labetalol Drug: Hydralazine Drug: nifedipine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols
Study Start Date : August 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: labetalol
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 Name: 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 Name: Apresoline
Active Comparator: nifedipine
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 Name: Procardia


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933593


Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Jennifer Goldkamp, MD St. Louis University
More Information
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Responsible Party: Jennifer Goldkamp, MD, Principal Investigator, St. Louis University
ClinicalTrials.gov Identifier: NCT02933593    
Other Study ID Numbers: 27295
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Labetalol
Hydralazine
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
 Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists