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临床试验/NCT02902354
NCT02902354撤回不适用

Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis

St. Louis University0 个研究点开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.

研究概览

简要总结

To determine the central blood pressure changes in normotensive women who are receiving nifedipine for uterine contraction suppression

详细描述

Only women whom have been prescribed nifedipine tocolysis by their covering obstetrician will be approached to participate in the study.

The patient will take their nifedipine as scheduled, we will attain central arterial pressure reading in addition to arterial waveform measurements. These will be collected:

Before administration of the medication Every 20 minutes for 3 hours (total of 10 measurements)

-This timing will allow measurements through approximately 2 half lives Routine sphygmomanometry will also be completed at the testing times All of these measurements will be collected for study purposes, although the nurses will have the opportunity to record the routine blood pressure measurements for their charting/vital signs assessment if they desire.

Once the patient has been monitored for 3 hours, her participation in the study is considered complete and no additional information will be collected. Each patient will serve as her own control (blood pressure prior to administration of medication), no randomization will occur.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Currently receiving tocolysis with nifedipine (10 or 20mg q4-6 hours)

排除标准

  • Multiple pregnancy
  • Diagnosis of hypertensive disorder in pregnancy or blood pressures 140/90 or higher on -more than 2 occasions.
  • Currently on antihypertensive medications (Nifedipine XL, labetalol, hydralazine, methyl-dopa, etc)
  • Currently on other tocolytic medications (exp: magnesium, Indocin)
  • Narcotic use
  • Renal diseaseI
  • 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
  • Severe tachycardia (>120)
  • Greater than 1st degree heart block
  • Severe asthma
  • Congestive heart failure or heart disease
  • Lupus, rheumatoid arthritis
  • Inability to adequately monitor BP
  • Magnesium treatment

研究组 & 干预措施

Nifedipine for tocolysis

Other

Only women receiving nifedipine (as standard of care) for tocolysis

干预措施: Nifedipine for tocolysis (Other)

结局指标

主要结局

To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.

时间窗: every 20 min for 3 hours

To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Goldkamp, MD

MD

St. Louis University

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