Efficacy of esomeprazole in the management of early preeclampsia.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
Age in both groups was comparable, with the mean age of control group 30.60 ± 1.59 years in control group and 30.68 ± 1.66 years in interventional group (p=0.52). Moreover, there was no significant difference between the two groups in the parity categories (p=0.24). It was found that patients who administered esomeprazole had significantly lower incidence of fits episodes than those who did not receive it (p=0.005). On the other hand, no maternal death was reported in both groups. Systolic and diastolic blood pressure had reported lower values in patients who took esomeprazole compared to their counterparts who did not receive it (p<0.001). Moreover, patients who administered esomeprazole had significantly lower umbilical artery resistance index (0.63 ± 0.09) than those who did not receive it (0.71 ± 0.09) (p=0.005). On the other hand, patients in esomeprazole group had significantly lower incidence of antepartum hemorrhage (p=0.005) and Disseminated intravascular coagulation (p=0.032). No intracranial hemorrhage was reported in both groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •A diagnosis of one of the following:
- •-preeclampsia.
- •-Gestational hypertension with evidence of preeclampsia.
- •-Unclassified proteinuric hypertension.
- •And all of the following is present:
- •-Gestational age between 26+0 and 31+6 weeks.
- •-Singleton pregnancy.
- •-Estimated fetal weight by ultrasound between 500
- •And1800g (if gestation not certain).
- •-No suspicions of a major fetal anomaly or malformation.
排除标准
- •-Patient is unable or unwilling to give consent.
- •-The presence of eclampsia.
- •-Severe hypertension.
- •-Established fetal compromise that necessitates delivery.
- •-Cardiovascular events.
- •-Contraindication or hypersensitivity to the use of esomeprazole.
- •-Current use of a drug that may be affected by a proton pump inhibitor.
- •-Elevated liver enzymes.
- •-Low platelets count.
- •-Liver hematoma.
- •-Left-sided heart failure.
- •-Severe ascites.
- •-Pulmonary edema.