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临床试验/NCT03321292
NCT03321292Unknown不适用

Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2017年10月15日最近更新:
适应症
干预措施
相关药物

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:

  1. Daily fetal movement counting
  2. Day after day CTG
  3. Doppler twice weekly
  4. 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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hayam Fathy Mohammad

Assistant Professor of Obstetrics and Gynecology , Ain Shams University

Ain Shams University

研究点 (1)

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