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临床试验/NCT02696577
NCT02696577已完成2 期

The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction

Assiut University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
68
试验地点
1
主要终点
Estimated fetal weight (gm)

研究概览

简要总结

Intrauterine growth restriction is a common and complex obstetric problem. Intrauterine growth restriction is noted to affect approximately 10-15 % of pregnant women. Intrauterine growth restriction is diagnosed antenatal; however, some of these fetuses, especially if unscreened during pregnancy, may be detected only in the neonatal period. It is very important for obstetricians and perinatologists to identify growth restricted fetuses, because this fetal condition is associated with significant perinatal morbidity and mortality.

Omega 3 is composed of polyunsaturated fatty acids with a double bond at the third carbon atom from the end of the carbon chain. The fatty acids have two ends, the carboxylic acid end, which is considered the beginning of the chain, thus "alpha", and the methyl end, which is considered the "tail" of the chain, thus "omega." Omega3 improve fetal wellbeing by two mechanisms: Firstly, maternal and docosahexaenoic acid supplementation during pregnancy and lactation normalizes intrauterine growth restriction induced changes in adipose deposition and visceral PPARγ expression. Secondly, maternal docosahexaenoic acid supplementation increases serum adiponectin, as well as adipose expression of adiponectin and adiponectin receptors. Novel findings suggest that maternal docosahexaenoic acid supplementation normalize adipose dysfunction and promote adiponectin-induced improvements in metabolic function in intrauterine growth restriction

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

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: from 20 - 35 years old.
  • Pregnant from 30 week to 32 week gestation.
  • Singleton pregnancy with asymmetrical intrauterine growth restriction .
  • Normal uterine and umbilical Doppler indices at time of recruitment.

排除标准

  • Multiple gestations.
  • Hypertensive women.
  • Premature rupture of membranes.
  • Abnormal Doppler indices in the form of Doppler blood flow indices > 2 standard deviation , absent diastolic flow and lastly; reversed flow.
  • Congenital fetal malformation.
  • Pregnancy complicated by antepartum hemorrhage.
  • Marked decrease in Amniotic fluid volume.

研究组 & 干预措施

Low dose aspirin

Active Comparator

Received aspirin 81mg once daily for 6 weeks

干预措施: Low dose aspirin (Drug)

Low dose aspirin plus omega 3 group

Active Comparator

Received aspirin 81mg and omega 3 once daily for 6 weeks.

干预措施: Low dose aspirin (Drug)

Low dose aspirin plus omega 3 group

Active Comparator

Received aspirin 81mg and omega 3 once daily for 6 weeks.

干预措施: Omega 3 (Drug)

结局指标

主要结局

Estimated fetal weight (gm)

时间窗: 1 year

次要结局

  • The changes in Doppler blood flow indices in both uterine arteries(1 year)
  • Fetal weight at the time of delivery (gm) ,(1 year)
  • Number of babies admitted to neonatal intensive care unit.(1 year)
  • The changes in Doppler blood flow indices in umbilical artery(1 year)

研究者

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

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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