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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02912910
• Other study ID #: 27464
• Status: Withdrawn
• Phase: N/A
• First received: September 12, 2016
• Last updated: November 8, 2017
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: November 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central blood pressure changes		every 30 min for 4 hours