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Trial record 67 of 143 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT02912910
Recruitment Status : Withdrawn (PI withdrew protocol)
First Posted : September 23, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Goldkamp, MD, St. Louis University

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

Condition or disease Intervention/treatment
Hypertension Other: Nifedipine Other: Labetalol

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Central Arterial Pressure When Comparing Nifedipine and Labetalol for Routine Hypertension Control in Pregnancy
Estimated Study Start Date : September 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. central blood pressure changes [ Time Frame: every 30 min for 4 hours ]


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
Sampling Method:   Probability Sample
Study Population
Women in our clinics in addition to admitted to our antepartum units will be screened for inclusion criteria.
Criteria

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

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): NCT02912910


Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Jennifer Goldkamp St. Louis University

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Responsible Party: Jennifer Goldkamp, MD, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT02912910     History of Changes
Other Study ID Numbers: 27464
First Posted: September 23, 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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Nifedipine
Hypertension
Vascular Diseases
Cardiovascular Diseases
Labetalol
Antihypertensive Agents
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
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists