Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Birth weight
研究概览
简要总结
Intrauterine growth restriction is an important problem in neonatal care. Intrauterine growth restriction (IUGR) is defined as a fetal weight below the 10th percentile for gestational age. One of the main causes of IUGR is placental insufficiency.
Nitric oxide(NO) increases placental blood flow. So,it might be useful to improve IUGR pregnancy outcome .
详细描述
The study population includes pregnant women attending Antenatal care clinic of Ain Shams University Maternity Hospital who first time diagnosed of IUGR at our antenatal care outpatient clinic either referred for this cause After confirm diagnosis of IUGR and distributing patient into two groups Patient in first group will receive oral L-arginine 3000mg/day till delivery and Acetylesalicylic acid 75mg once daily.
Patients in second group will receive Acetylesalicylic acid 75mg once daily. then follow up of both group by:
- Daily fetal movement counting
- Day after day CTG
- Doppler twice weekly
- Pelvic u/s weekly for:
A) Head circumference, Abdominal circumference, femur length B) Fetal weight C) Liquor amount: Amniotic Fluid Index Or MeanVertical Pocket
Decision of delivery will be determined when:
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All pregnant women diagnosed with IUGR from 28 weeks
- •Singleton pregnancy
- •No maternal systemic disease
- •No congenital fetal malformation
- •Estimated fetal weight below 10th percentile
排除标准
- •All pregnant woman diagnosed with IUGR before 28 weeks
- •Multiple pregnancy
- •Maternal systemic disease
- •Congenital fetal malformation
研究组 & 干预措施
L-arginine and Acetylesalicylic acid
L-arginine 1000mg capsules( manufactured by Putriant Pride,INC Holbrook,NY 11741 U.S.A.) every 8 hours Acetylesalicylic acid 75 mg tablet(manufactured by Multi_Apex Pharma , Egypt) once daily will be given for patients of group A starting from diagnosis till birth
干预措施: L-arginine 1000 mg and Acetylesalicylic acid75mg (Drug)
Acetylesalicylic acid75mg
acetylsalicylic acid 75 mg tablet(manufactured by Multi_Apex Pharma , Egypt) orally once daily will be given for patients of group B starting from diagnosis till birth
干预措施: acetylsalicylic acid 75 mg (Drug)
结局指标
主要结局
Birth weight
时间窗: 15 min
neonatal birth weight will be measured immediately following delivery and compared with the estimated fetal weight measured by ultrasound
次要结局
- Umbilical artery Doppler(every from 28 weeks gestation till 40 weeks gestation)
- Apgar score(at one and five minute after birth.)
- Amniotic fluid index(evey one week from 28 weeks gestation till 40 weeks gestation)
研究者
Hayam Fathy Mohammad
Assistant Professor of Obstetrics and Gynecology , Ain Shams University
Ain Shams University