Efficacy of Diltiazem for the Control of Blood Pressure in Puerperal Patients With Severe Preeclampsia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Systolic blood pressure
研究概览
简要总结
Both preeclampsia and eclampsia are important health problems, being an important cause of maternal death in the world.
Nifedipine has been used as the drug of choice for the treatment of hypertension during puerperium for more than 25 years.
Diltiazem is an alternative calcium antagonist that is 1000 times less potent than nifedipine.
There are no reports in the literature, no randomized clinical trials that prove the effectiveness of diltiazem for the control of blood pressure in post-partum patients with severe preeclampsia.
详细描述
Both preeclampsia and eclampsia are important health problems, being an important cause of maternal death in the world. Although these two pregnancy-related disorders have been widely studied, their cause remains unknown. Pathophysiological mechanism involves the reduction of maternal placental blood flow as of week 20 of gestation, with an increase in peripheral vascular resistance that predominantly takes place in the kidney, liver and brain.
Nifedipine has been used as the drug of choice for the treatment of hypertension during puerperium for more than 25 years. However, there are various studies that report in sensible population the presence of serious adverse effects with the use of this drug, such as cerebral ischemia, myocardial ischemia or tachycardia, as well as episodes of hyper- and hypotension. Consequently, it is necessary to find treatment alternatives for this case.
Diltiazem is an alternative calcium antagonist that is 1000 times less potent than nifedipine, which has the property of producing a selective vasodilatation of arteries beds.
There are no reports in the literature, no randomized clinical trials that prove the effectiveness of diltiazem for the control of blood pressure in post-partum patients with severe preeclampsia.
The objective of this study is to evaluate if diltiazem improves the blood pressure parameters in early puerperium patients with severe preeclampsia.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The following parameters of all patients were within the normal range: hematic biometry, urine and glucose tests, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, blood coagulation test including prothrombin time and activated partial thromboplastin time. Electrocardiogram and chest radiography showed no pathological data.
排除标准
- •When the patient falls outside of the aforementioned parameters, or subjects with unstable medical conditions.
研究组 & 干预措施
Diltiazem
Postpartum patients were administered (60 mg) orally every 8 hours with diltiazem (tables).
干预措施: Diltiazem (Drug)
Nifedipine
Postpartum patients were administered (10 mg) orally every 8 hours with nifedipine (capsule).
干预措施: Diltiazem (Drug)
结局指标
主要结局
Systolic blood pressure
时间窗: The register was taken during the 48-hour observation period
Diastolic blood pressure
时间窗: The register was taken during the 48-hour observation period
Mean blood pressure
时间窗: The register was taken during the 48-hour observation period
次要结局
- Number of hypotension episodes(The counts was taken during the 48-hour observation period)
- Days of stay in the intensive care unit(The counts was taken during the two-weeks observation period)
研究者
Dr. Gilberto Arias-Hernández
Physician of the Intensive Care Unit
Hospital de la Mujer