Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols
NCT ID: NCT02933593
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-08-31
2017-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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labetalol
labetalol
Labetalol
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
hydralazine
Hydralazine
Hydralazine
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
nifedipine
nifedipine
nifedipine
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Interventions
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Labetalol
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Hydralazine
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
nifedipine
To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Severe hypertension as defined by a blood pressure of 160/110 with plans to treat
Exclusion Criteria
* 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
14 Years
50 Years
FEMALE
Yes
Sponsors
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St. Louis University
OTHER
Responsible Party
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Jennifer Goldkamp, MD
Principal Investigator
Principal Investigators
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Jennifer Goldkamp, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
Other Identifiers
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27295
Identifier Type: -
Identifier Source: org_study_id