The Comparison of Serum and Colostral Melatonin, and IL-6 Levels Between Women With Vaginal Delivery, Emergency Cesarean Section and Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The serum IL-6 level
研究概览
简要总结
The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section
详细描述
In this prospective randomized study, the investigators aimed to show the changes in the melatonin levels in colostral milk in spontaneous vaginal delivery,emergency cesarean and elective cesarean section patients and changes in blood IL-6 level before and after the delivery in same patient groups.
the investigators randomized 30 cases for each group for comparisons.Time range seems short in this study but participating hospital setting is a busy maternity hospital thus it will be performed easily.
The purpose of this study is to demonstrate the beneficial effect of spontaneous vaginal delivery on the secretion of melatonin which is solely secreted by the mother and the newborn is dependent on maternal milk oriented melatonin until 12 th week after delivery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women reached term
- •Patients with spontaneous vaginal delivery
- •Patients preferred cesarean section electively
- •Patient who had emergency cesarean section without additional medical or surgical problems
排除标准
- •Women who had history of intrauterine fetal loss
- •Hypertention during pregnancy
- •Thyroid diseases
- •Patients with chronic diseases
- •Drug users
研究组 & 干预措施
women with vaginal delivery
30 women with spontaneous vaginal delivery will be included in group 1 serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured
干预措施: The calculation of blood IL-6 and coloctral milk melatonin (Other)
women with emergency cesarean section
30 women with emergency cesarean section will be included in group 2 serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured
干预措施: The calculation of blood IL-6 and coloctral milk melatonin (Other)
women with elective cesarean section
30 women with elective cesarean section will be included in group 3serum IL-6 levels before and after delivery and colostral milk melatonin levels will be measured
干预措施: The calculation of blood IL-6 and coloctral milk melatonin (Other)
结局指标
主要结局
The serum IL-6 level
时间窗: 8 weeks
the measurement of serum IL-6 level in blood
Colostral Milk melatonin levels in different types of deliveries
时间窗: 8 weeks
Colostral milk taken from the postpartum midnight breast milk were evaluated for melatonin levels
次要结局
未报告次要终点
研究者
canan soyer çalışkan
MD
Samsun Education and Research Hospital