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Retrospective Review of NSAIDS in the Postpartum Period

2017年11月8日 更新者:Jennifer Goldkamp, MD、St. Louis University

Hypertension and NSAIDS in the Postpartum Period

Chart review of women who have delivered an infant in a single health care system to determine if NSAID use increases blood pressures in the postpartum period.

研究概览

地位

撤销

干预/治疗

详细说明

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common medication used for pain relief in the postpartum period in the United States. For pain relief of uterine involution, NSAIDs have shown to be superior to placebo, and equivalent or superior to narcotics. In 2013 the American College of Obstetricians and Gynecologists (ACOG) discouraged the use of NSAIDs in women with pre-eclampsia due to concerns for inadvertently increasing blood pressure. This recommendation is based on non-obstetrics literature, which tended to show a small increase of blood pressures in patients who use NSAIDS. However the literature is mixed, particularly on ibuprofen which is the most common NSAID used in the postpartum. Of the two meta-analysis that are commonly referenced, Pope et al found a decrease of -0.3 (+/- 2.57) mmHg in mean arterial pressure (MAP) in patients with hypertension treated with ibuprofen, and Johnson et al identified an average of 5mmHg increase in blood pressure with ibuprofen use. A large study of 18,325 patients who were treated with NSAIDS or COX-2 inhibitors, found an average of a 2.1 (+/- 0.5) mmHg increase in blood pressure with ibuprofen administration.

There are two articles available in the obstetrics literature on the topic of NSAIDS in women with hypertension disorders. The first is by Makis et al, and is a case series of six women, with discussion of two cases. The explanations of hypertension causes are limited and possible alternate diagnoses are not discussed (6). The second by Wasden et al is a retrospective study of women who had the diagnosis of severe hypertension disorders in pregnancy. The patients were matched 2:1 for women exposed to NSAIDs versus those who did not receive NSAIDs. MAPs were compared, and there was no difference found between the two groups. This second study is better designed and is likely representative of the true outcome of NSAID use in pre-eclamptic women, as the general literature shows a small, non-clinically significant change in blood pressure readings.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Missouri
      • Saint Louis、Missouri、美国、63117
        • St. Mary's Health Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 45年 (孩子、成人)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

pregnant, All ethnic backgrounds will be included.

描述

Inclusion Criteria:

  • received NSAIDs post delivery for pain

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
NSAID use
The purpose of this study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.
The purpose of the study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
pain relief
大体时间:1 year
to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年1月18日

初级完成 (预期的)

2018年4月1日

研究完成 (预期的)

2019年4月1日

研究注册日期

首次提交

2017年1月18日

首先提交符合 QC 标准的

2017年1月18日

首次发布 (估计)

2017年1月20日

研究记录更新

最后更新发布 (实际的)

2017年11月13日

上次提交的符合 QC 标准的更新

2017年11月8日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 26975

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Post Partum Pain的临床试验

NSAID use的临床试验

3
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