Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening in Term Induction of Labor With Unfavorable Cervix:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- o Bishop Score and cervical dilatation
研究概览
简要总结
Mechanical methods used for induction of labor received a great attention nowadays due to the serious side effects of the pharmacological methods. Hygroscopic dilators are considered important subtype of these mechanical methods. One of them is Laminaria which is a synthetic type of sea algae that induces cervical dilation by absorbing water from the cervix and gradually increasing in thickness. The current study will compare the effectiveness and safety of laminiria and vaginal prostaglandins in induction of labor in women with unfavorable cervix.
详细描述
A new method for induction of labor to be studied
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with:
- •Age 18-45 years.
- •Live fetus with cephalic presentation.
- •Normal non-stress test with reassuring features (baseline heart rate 110-160 beats/min, baseline variability 5-25 beats/minute, and no decelerations) (National Institute for Health and Clinical Excellence 2017).
- •Gestational age of 37 weeks or more (Middleton et al. 2020).
- •Fetal weight less than 4 kilograms.
- •Bishop score less than 6 (Navve et al. 2017).
- •No labor pains.
- •No contraindications for vaginal delivery
排除标准
- •o Presence of fetal distress.
- •Presence of thick meconium-stained amniotic fluid
- •Presence of fever, chorioamnionitis, or vaginal bleeding before intervention.
研究组 & 干预措施
Laminaria tents group
Laminaria tent used to be inserted in cervix and left for 6-12 hours
干预措施: Laminaria (Device)
Laminaria tents group
Laminaria tent used to be inserted in cervix and left for 6-12 hours
干预措施: Vaginal prostaglandin (Drug)
vaginal prostaglandin group
Misoprostol 25 mcg inserted for one or multiple doses
干预措施: Laminaria (Device)
vaginal prostaglandin group
Misoprostol 25 mcg inserted for one or multiple doses
干预措施: Vaginal prostaglandin (Drug)
结局指标
主要结局
o Bishop Score and cervical dilatation
时间窗: 2 YEARS
Tool to assess cervical status
次要结局
- o Induction time to active phase of labor.(2 YEARS)
- o Induction time to delivery time.(2 YEARS)