Efficacy of L- Arginine Versus Sildenafil in Management of Idiopathic Oligohydramnios
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Improvement of amniotic fluid index
研究概览
简要总结
Based on previous studies, Both sildenafil and L-arginine helped to improve idiopathic oligohydramnios.
In this study, Level of improvment of oligohydramnios will be compared. As well as, NICU admission to neonates of pregnancies complicated by idiopathic oligohydramnios. The end goal is to help physicians use the best drug for their patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with gestational age between 26-37 weeks
- •Pregnant women whose age is < 35 years
- •Woman with other indication for elective caesarean section.
- •Women carrying a single fetus with no major anomalies.
- •Initial amniotic fluid index <8cm determined by reliable pelivabdominal ultrasound.
排除标准
- •Women complaining of other obstetric disorder such as, PPROM, preeclampsia, or diabetes.
- •Women with chronic illness such as, chronic hypertension, autoimmune disease or kidney disease.
- •Women who received other treatments for oligohydramnios in current pregnancy.
- •Women who smoke.
- •Fetuses with major congenital anomaly.
研究组 & 干预措施
sildn arm
In this group, participants receive sildenafil 25 mg thrice a day. then amniotic fluid index is measured every week to measure its improvement. After delivery, APGAR will be measured. As well as, whether the fetus entered the NICU or not will be recorded.
干预措施: Sildenafil 25 MG (Drug)
L- argin arm
In this group, participants receive L- arginine 1000 mg thrice a day. then amniotic fluid index is measured every week to measure its improvement. After delivery, APGAR will be measured. As well as, whether the fetus entered the NICU or not will be recorded.
干预措施: L-Arginine, 1000 Mg Oral Tablet (Drug)
结局指标
主要结局
Improvement of amniotic fluid index
时间窗: two hours before cesarean section
Amniotic fluid index level measured before delivery.
次要结局
- NICU admission(first day after delivery)
- APGAR score(5 minutes after delivery)
研究者
Ibtesam Teleb Mohamed Yousef Gadalla
principle investigator
Kafrelsheikh University