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临床试验/NCT01761916
NCT01761916已完成4 期

Randomized Clinical Trial for Effectiveness of Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure

Instituto Materno Infantil Prof. Fernando Figueira1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Time until resolution of very high blood pressure episode

研究概览

简要总结

The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.

Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.

The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.

Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.

There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.

The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.

详细描述

The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.

Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.

The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.

Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.

There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Hypertensive disorders of pregnancy;
  • Postpartum;
  • Age 18 to 45 years;
  • Very high blood pressure

排除标准

  • Cardiac disease;
  • Use of illicit drugs that may interfere with maternal hemodynamics;
  • Contraindications to the use of captopril: renal failure, chronic liver disease and hypersensitivity to the drug;
  • Contraindications to the use of clonidine: sinus node disease, chronic liver disease and hypersensitivity to the drug;
  • Inability to receive postpartum oral medications

研究组 & 干预措施

CLONIDINE

Experimental

Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg)

干预措施: CLONIDINE (Drug)

CAPTOPRIL

Active Comparator

Postpartum patients with very high blood pressure will be treated with oral CAPTOPRIL (25mg)

干预措施: CAPTOPRIL (Drug)

结局指标

主要结局

Time until resolution of very high blood pressure episode

时间窗: During hospital stay, up until one month postpartum

The time until resolution of very high blood pressure episode after clonidin or captopril use.

次要结局

  • Maternal outcomes(During hospital stay, up until one month postpartum)

研究者

发起方
Instituto Materno Infantil Prof. Fernando Figueira
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leila Katz

MD pHD

Instituto Materno Infantil Prof. Fernando Figueira

研究点 (1)

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