Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The mean difference between blood pressure measurements in both groups
研究概览
简要总结
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum
详细描述
Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 20+0 and 33+6 weeks.
- •Singleton pregnancy.
- •Willing to participate in the study and sign the informed consent.
排除标准
- •Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
- •Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations).
- •Platelet count < 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
- •Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
- •Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
- •Severe Oligohydramnios (AFI < 5cm)
- •Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
- •Eclampsia;
- •Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/or recurrent variable or late decelerations);
- •Intrauterine fetal death.
- •Patient is unable or unwilling to give consent.
- •Patients currently using progesterone for other indications.
研究组 & 干预措施
study group
women will be given 17-OHPC 250 mg intra-muscular at admission and every 7 days thereafter in addition to other conservative measures of early-onset PE
干预措施: 17 Hydroxyprogesterone Capronate (Drug)
结局指标
主要结局
The mean difference between blood pressure measurements in both groups
时间窗: one month
blood pressure measured by mercury sphygmomanometer
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
principal investigator
Assiut University