Does Induction Dosage in Latent Phase Affect Active Phase of Labor?A Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- need for oxytocin retreatment
研究概览
简要总结
This study evaluates the need of oxytocin therapy in active phase of labor. there will be two groups treating with oxytocin in latent phase.One group will be treated with low dose oxytocin therapy and the other group will be treated with high dose oxytocin therapy. oxytocin treatment will be ceased at the beginning of the active phase of labor. the need of oxytocin treatment in active phase of labor will be compared between two groups.
详细描述
Oxytocin treatment in active phase of labour is used with respect to clinicians preference and best approach has not been described. We want to investigate the effect of oxytocin treatment by using different regims in latent phase of labor when oxytocin treatment is ceased in active phase of labour. In our trial we discontinued oxytocin in active phase of labour and investigate which group needs oxytocin therapy due to inadequate uterine contractions and arrest of labor.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Live fetus in cephalic presentation, sonographically estimated fetal weight less than 4200 g, undergoing induction of labor at 37-42 weeks of gestation, having indications of labor, no previous uterine surgery
排除标准
- •malpresentation, placenta previa, previous uterine surgery, multiple gestation, active genital herpes, non-reassuring fetal heart rate pattern
研究组 & 干预措施
low dose group
oxytocin therapy starting with 2mU/min increased by 2 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.
干预措施: oxytocin (Drug)
high dose group
oxytocin therapy starting with 4mU/min increased by 4 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.
干预措施: oxytocin (Drug)
结局指标
主要结局
need for oxytocin retreatment
时间窗: an average of one year
need for oxytocin retreatment due to inadequate uterine contractions and labor arrest
次要结局
- total oxytocin dose(an average of one year)
- APGAR scores(an average of one year)
- length of active phase(an average of one year)
- ratio of caesarean section(an average of one year)
研究者
Ahmet Eser
principal investigator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital