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临床试验/NCT04161989
NCT04161989已完成不适用

The Effect of Omega 3 and Vaginal Progesterone on Birth Weight and Doppler Velocimetry of Constitutionally Small for Gestational Age Fetuses.

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月1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
状态
已完成
入组人数
80
试验地点
1
主要终点
The difference in mean birth weight (gram)

研究概览

简要总结

Small for gestational age refers to an infant born with a birth weight less than the 10th centile. Severe small for gestational age refers to an infant born with a birth weight less than the 3rd centile. Constitutionally small fetuses are fetuses whose growth at all gestational ages has been low but otherwise healthy. Those babies have a great risk for perinatal morbidity and mortality. Many causes are responsible for the development of Severe small for gestational age, however; in a few cases, the cause could not be detected. In contrast to pathologic intrauterine growth restriction, the constitutionally small fetuses have normal umbilical and middle cerebral artery Doppler velocimetry and normal amniotic fluid volume. In this circumstance, continued biophysical testing and delivery at 38-39 weeks is reasonable. Low birth weight fetuses comprise both preterm births and SGA. They are at a higher risk of adverse birth outcomes. So the trials to increase the blood flow to the uterus and/or the fetus may improve the neonatal outcomes. There are many lines of treatment that have been emerged now for the treatment of small for gestational age fetuses like maternal rest and oxygenation, aspirin therapy, supplementation of zinc, and fish oil. However; all mentioned lines of treatment lack evidence of effectiveness in literature. Omega-3 fatty acids as antioxidants inhibit the free radicals released during pregnancy which are responsible for vasoconstriction; so vasodilatation will occur. This leads to increase blood flow to the uterus and placenta which improves pregnancy outcomes. Progesterone is a smooth muscle relaxant and has a vasodilator effect on the blood vessels. It causes endothelium- relaxation of human placental arteries and veins. This relaxation is significant for maintaining low flow impedance and satisfactory blood flow in the placental circulation. DeFranco et al observed that vaginal progesterone is associated with vascular relaxation and increased uterine blood flow. But, he did not observe this vascular effect in women receiving systemic progesterone. So from the above evidence; there is a need to study the effect of omega 3 and progesterone on pregnant women whose pregnancy is complicated with constitutionally small for gestational age fetuses in trial to find a new line of treatment of this problem.

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

  • Pregnant women aged 20-35 years.
  • Pregnant women from 28 to 30 weeks gestation.
  • Women with small for gestational age fetus. It refers to an estimated fetal weight or abdominal circumference <10th centile with no pathology is present.
  • Women with normal resistant index in uterine arteries at the time of recruitment.
  • Women with normal resistant index in umbilical arteries at the time of recruitment.

排除标准

  • Women with estimated fetal weight below the 5th or 3rd percentile.
  • Women with any major risk factors for intrauterine growth restriction.
  • Women with multiple pregnancies.
  • Women with low amniotic fluid volume or premature pre-labor rupture of membranes.
  • Women with antepartum hemorrhage or fetal congenital anomalies.
  • Women with absent or reversed diastolic flow in the umbilical artery at the time of recruitment.
  • Women with any contraindications for progesterone or omega
  • Women who refused to participate in our study.

研究组 & 干预措施

Group I (omega-3 fatty acids group)

Other

received omega 3 (Omega 3 plus, SEDICO, Egypt); once daily from 28-30 weeks till delivery. The omega 3 plus capsule contains 1000 mg Fish Oil plus 100 mg Wheat Germ Oil is a natural source of Vitamin E.

干预措施: omega-3 fatty acids (Drug)

Group II (vaginal progesterone plus omega-3 group)

Other

received vaginal progesterone (Prontogest 400 mg vaginal suppository, Marcyrl Pharmaceutical Industries, Egypt) and omega 3 once daily from 28-30 weeks till delivery.

干预措施: omega-3 fatty acids (Drug)

Group II (vaginal progesterone plus omega-3 group)

Other

received vaginal progesterone (Prontogest 400 mg vaginal suppository, Marcyrl Pharmaceutical Industries, Egypt) and omega 3 once daily from 28-30 weeks till delivery.

干预措施: vaginal progesterone (Drug)

结局指标

主要结局

The difference in mean birth weight (gram)

时间窗: 6 weeks

次要结局

  • Estimated fetal weight (gram)(6 weeks)
  • Time of delivery (weeks)(6 weeks)
  • Doppler indices in the umbilical artery(6 weeks)
  • Doppler indices in the uterine artery(6 weeks)

研究者

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

Mohammed Khairy Ali

Lecturer

Assiut University

研究点 (1)

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