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临床试验/NCT01988298
NCT01988298已完成2 期

Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.

Complejo Hospitalario Dr. Arnulfo Arias Madrid1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
level of postpartum hypertension

研究概览

简要总结

Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. The available data in the medical literature have primarily focused on antenatal and peripartum management. There are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. Some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension.

The purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.

详细描述

Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. We include only women with vaginal delivery.

研究设计

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

入排标准

年龄范围
15 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia

排除标准

  • sensitivities to ibuprofen cesarean delivery

研究组 & 干预措施

Ibuprofen

Experimental

Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.

干预措施: Ibuprofen (Drug)

Acetaminophen

Active Comparator

Acetaminophen 1 g oral each 6 hours, 2-3 days.

干预措施: Acetaminophen (Drug)

结局指标

主要结局

level of postpartum hypertension

时间窗: levels of hypertension up to 4 days post paertum

hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory

次要结局

  • complications(complications during the postpartum period (4 days))

研究者

发起方
Complejo Hospitalario Dr. Arnulfo Arias Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulino Vigil-De Gracia

Gynecology and obstetric, investigator and teaching proffesor

Complejo Hospitalario Dr. Arnulfo Arias Madrid

研究点 (1)

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