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临床试验/NCT06565728
NCT06565728已完成1 期

Comparative Study of the Role of Vitamin D Supplementation, Versus Sildenafil Citrate in Patients Diagnosed With Fetal Growth Restriction, Randomized Control Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2022年11月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
99
试验地点
1
主要终点
Gestational age Measurements

研究概览

简要总结

Fetal growth restriction, also named Intrauterine growth restriction is a prevalent disease in pregnancy , it is a descriptive term for a pathological process, and can be described as the process where a fetus who has a certain growth potential based on genetic criteria is limited in its growth because of a pathological environmental influence

详细描述

Fetal or Intrauterine growth restriction, describes a pathological condition in which the fetus fails to grow to its biological potential, because of poor placental function , both American society of obstetrics and gynecology of and Royal college of obstetrics and gynecology have adopted the definition of Intrauterine growth restriction as estimated fetal weight is less than 10th percentile .

It is a multifaceted problem that increases the risk of hypoxemia, acidemia, preterm deaths, and maternal distress, and disposes the infant to a number of metabolic disorders, polycythemia, lung problems, intraventricular hemorrhage, cognitive dysfunction, and cerebral palsy, which occur in both term and preterm infants .

Vitamin D deficiency is highly prevalent among pregnant women, not only vitamin D deficiency during pregnancy causes maternal and fetal side effects, it also increases the risk of preeclampsia, gestational diabetes, preterm birth, and birth of a child younger than small for gestational age, inadequate fetal immune system, wheezing and eczema, and risk of respiratory infections in the infants.

Vitamin D is a transcriptional regulator of endothelial NO synthase, effectively increasing the production of NO, the most potent vasodilator within the vasculature. previous Studies showed that the vitamin-D receptors play a critical role in maintaining vascular health, and this assumption was supported by data Showing reduced NO production.

It was suggested that vitamin D improves vascular function via reducing the production of NO-scavenging oxygen radicals and subsequently improving NO bioavailability and maintain vascular health.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with singleton spontaneous pregnancy with fetal growth restriction more than 28 weeks, confirmed by ultrasound based on estimated fetal weight and measurement of abdominal circumference (AC)< 10th percentile for gestational age or lag of two weeks or more between the current measurements and expected one, dating since the first trimester of pregnancy.
  • Age 20- 40 years.
  • Patients with regular menstrual pattern before pregnancy.
  • Patients are able to attend follow up as planned.

排除标准

  • Patients with uncertain gestational age
  • Maternal cardiovascular disease (congenital, ischemic and rheumatic heart diseases), diabetes, kidney disease, hepatic disease, anemia, antepartum hemorrhage and placenta previa.
  • Patients with known or suspected foetal anomalies
  • Fetal growth restriction because of severe preeclampsia.
  • Use of vasodilator medication.
  • Multiple pregnancies
  • Smoking, drugs or alcohol abusers.
  • Obstetric complications (intrauterine infection, bleeding, premature rupture of membranes).

研究组 & 干预措施

Group A: Vitamin D3 group

Active Comparator

Consists of 33 pregnant women who received oral vitamin D3 (vitamin D-3 2000 IU) and low dose aspirin.

干预措施: Vitamin D3 2000 UNT Oral Tablet (Drug)

Group A: Sildenafil group

Active Comparator

Consists of 33 pregnant women who received oral sildenafil citrate 20 mg (Respatio) and low dose aspirin

干预措施: Vitamin D3 2000 UNT Oral Tablet (Drug)

Group A: Control group

Active Comparator

Consists of 33 pregnant women who received low dose aspirin only

干预措施: Vitamin D3 2000 UNT Oral Tablet (Drug)

结局指标

主要结局

Gestational age Measurements

时间窗: 6 months

Estimation of The Gestational age at the week 28 of gestation by measuring fetal head circumference, Abdominal Circumference and fetal femur length.

次要结局

未报告次要终点

研究者

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

Hanaa Ramadan

Resident of Obstetrics and Gynecology

Cairo University

研究点 (1)

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