Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

NCT02933593 | Withdrawn

• 1 other identifier: 27295
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• medication recommended by ACOG for severe hypertension

  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

Study Arms (3)

labetalol

ACTIVE COMPARATOR

labetalol

Drug: Labetalol

hydralazine

ACTIVE COMPARATOR

Hydralazine

Drug: Hydralazine

nifedipine

ACTIVE COMPARATOR

nifedipine

Drug: nifedipine

Interventions

Labetalol DRUG

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

Also known as: Trandate®

labetalol

Hydralazine DRUG

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

Also known as: Apresoline

hydralazine

nifedipine DRUG

To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.

Also known as: Procardia

nifedipine

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Louis University: lead

MeSH Terms

Conditions

Hypertension

Interventions

Labetalol; Hydralazine; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• Jennifer Goldkamp, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: October 14, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share