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临床试验/NCT02168309
NCT02168309已完成不适用

Comparison of Oral Nifedipine to Oral Labetolol for the Management of Severe Postpartum Hypertension

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication

研究概览

简要总结

This study's aim is to determine whether oral extended release nifedipine is superior to oral labetolol for the management of postpartum severe hypertension, specifically time to achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended release nifedipine is superior to oral labetolol for achieving goal blood pressure in the postpartum period.

详细描述

Hypertension complicating pregnancy is common and, when uncontrolled, can have devastating consequences. While the true incidence of postpartum hypertension is unknown, blood pressure (BP) is known to initially decrease 48 hours following delivery then peak on postpartum days 3-6, likely 45 from the mobilization of interstitial fluids following parturition.

The American College of Obstetricians and Gynecologists (ACOG) recommends medical treatment of persistent postpartum hypertension, defined as systolic BP (SBP) ≥150 mmHg or diastolic BP (DBP) ≥100 mmHg, on two or more occasions 4-6 hours apart. Prior studies compared intravenous medications to intramuscular and immediate-release oral 50 medications in the treatment of postpartum hypertension. However, oral labetalol and oral extended release nifedipine are the most commonly used medications for post- partum hypertension, and their efficacy has not been directly compared.

Our aim was to determine whether oral labetalol is associated with a shorter time to BP control compared to oral extended release nifedipine for management of persistent 55 postpartum hypertension. Our primary outcome was time to sustained BP control defined as the absence of severe hypertension (SBP ≥160 mmHg or DBP ≥105 mmHg) for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient-reported side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 18 years with the abililty to give informed consent
  • Intrauterine pregnancy ≥ 32 weeks
  • Postpartum
  • Persistent postpartum blood pressures ≥ 160/105 on two or more occasions
  • Primary obstetrician amenable to starting either study medication in the postpartum period

排除标准

  • Use of other oral antihypertensives concomitantly
  • Known AV heart block
  • HR <60 or >120
  • Absolute contraindication to nifedipine or labetolol such as allergy
  • Significant renal disease (Cr >1.5 mg/dL)
  • Heart failure
  • Moderate persistent or severe asthma
  • Preexisting diagnosis of chronic hypertension with medical treatment before delivery
  • Chronic hypertension

研究组 & 干预措施

Labetalol

Other

Labetalol 200mg PO BID starting dose

干预措施: Labetalol (Drug)

Nifedipine

Other

Nifedpine XL starting at dose 30mg PO daily

干预措施: Nifedipine (Drug)

结局指标

主要结局

Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication

时间窗: 24 hours

Primary outcome

次要结局

  • Total Length of Hospital Stay in Days(0-10 days)

研究者

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

Sarah Kilpatrick

Chair, Department of Obstetrics & Gynecology

Cedars-Sinai Medical Center

研究点 (1)

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