Evaluation of Oxidative and Antioxidative Status of Pregnant Women Suffering From Threatened Preterm Birth During Tocolytic Treatment With Atosiban
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Delay preterm delivery for 48 hours
研究概览
简要总结
Oxidative stress is recognized as a important factor in the pathogenesis premature birth. Preterm birth is defined as delivery before 37 completed weeks of gestation and it is the leading cause of neonatal morbidity and mortality. The investigators conducted this analysis to investigate the safety of administration of Atosiban - a reversible, competitive antagonist of the oxytocin receptor in the treatment of preterm labor and its impact on the level of oxidative stress after 48 hours of tocolytic treatment.
详细描述
Atosiban (1-(3-mercaptopropanoic acid)-2-(O-ethyl-D-tyrosine)-4-L-threonine-8-L-ornithine-oxytocin) is licensed for clinical use in women suffering from threatened premature birth and is widely used in clinical practice in Europe because of its low side effect profile. The impact of Atosiban on pregnancy outcomes in women has been investigated in recent years and the research has shown its ability to reduce intracytoplasmic calcium release and downregulate prostaglandin synthesis as oxytocin receptor antagonist. While a role of Atosiban in the modulation of myometrial contractility is well-described, its effect on many other functions is not so well known.
The serum and plasma samples take for the measurement of total oxidant status (TOS), total antioxidant status (TAS), level of 3-nitrotyrosine (3-NT), and carbonyl and thiol groups will be stored at -70°C in aliquots for subsequent biochemical analysis and processed within two months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women between 24-35 weeks' gestation receiving prenatal care due to the risk of premature birth
- •intact membranes
- •evidence of premature labor (regular, painful and persistent uterine contractions; cervical changes)
排除标准
- •acute fetal distress
- •other conditions requiring immediate delivery (eclampsia and severe pre-eclampsia, placenta previa, abruptio placenta)
- •vaginal bleeding,
- •premature rupture of membranes
- •chorioamnionitis,
- •fetal congenital malformations,
- •intrauterine growth restriction,
- •the use of any tocolytic drugs during pregnancy before admission to the hospital
- •circulatory system diseases (e.g. heart defects, hypertension),
- •symptoms of infection
- •other diseases that may increase oxidative stress
研究组 & 干预措施
Atosiban
Total oxidant status (TOS), total antioxidant status (TAS) and oxidative stress index (OSI) values as well as 3-nitrotyrosine, carbonyl and thiol groups levels weill be measure using ELISA test in serum and plasma of 64 pregnant women before and after 48 hours of continuous administration of Atosiban.
干预措施: Atosiban (Drug)
结局指标
主要结局
Delay preterm delivery for 48 hours
时间窗: 48 hours
Delay preterm delivery for 48 hours, thus allowing administration of corticosteroids to induce surfactant production in fetal lungs and improve neonatal outcome
次要结局
- Weight(At birth)
- Apgar score(At birth)
- Time to delivery measured from start of Atosiban administration(Up to 15 weeks from start of Atosiban administration)
- Incidence of duration of hospitalization(Up to 28 days after birth)