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

NCT02912910 | Withdrawn

• 1 other identifier: 27464
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• central blood pressure changes

  every 30 min for 4 hours

Study Arms (2)

Nifedipine

patients will be assigned to antihypertensive medications by their physicians in the course of their routine care

Other: Nifedipine

Labetalol

patients will be assigned to antihypertensive medications by their physicians in the course of their routine care

Other: Labetalol

Interventions

Nifedipine OTHER

patients will be assigned to antihypertensive medications by their physicians in the course of their routine care

Nifedipine

Labetalol OTHER

patients will be assigned to antihypertensive medications by their physicians in the course of their routine care

Labetalol

Eligibility Criteria

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

Study Population

Women in our clinics in addition to admitted to our antepartum units will be screened for inclusion criteria.

You may qualify if:

• Singleton pregnancy
• Women with hypertensive disease in pregnancy who are currently being treated with nifedipine xl or labetalol

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine; Labetalol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jennifer Goldkamp

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 23, 2016
• Study Start: September 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