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

Withdrawn

• Conditions: Hypertension
• Interventions: Other: Labetalol; Other: Nifedipine

• Registration Number: NCT02912910
• Lead Sponsor: St. Louis University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Labetalol	Labetalol	patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
Nifedipine	Nifedipine	patients will be assigned to antihypertensive medications by their physicians in the course of their routine care

Primary Outcome Measures

Name	Time	Method
central blood pressure changes	every 30 min for 4 hours