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临床试验/NCT00843362
NCT00843362已完成4 期

A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4

Università degli Studi di Brescia1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
133
试验地点
1
主要终点
spontaneous vaginal delivery

研究概览

简要总结

The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the synthetic prostaglandins most commonly used to achieve cervical ripening and labour induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical) or as a controlled-release intravaginal pessary. The controlled-release pessary has some potential advantages: a single application is required; the insert is easily administered and can be removed as soon as labour starts or if complications ensue. Studies comparing the dinoprostone vaginal insert to other prostaglandin formulations have shown variable results, probably influenced by drug administration regimens, indications for induction, and cervical conditions of the women. The purpose of this study is to assess the efficacy of the induction of labour using dinoprostone in patients with an unfavourable cervix, and to compare the efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal dinoprostone gel.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks

排除标准

  • premature rupture of the membranes, history of a previous caesarean section,
  • maternal clinical contraindications to the administration of prostaglandins,
  • fetal malpresentation

研究组 & 干预措施

1

Experimental

24-hours vaginal dinoprostone pessary

干预措施: Dinoprostone vaginal pessary (Drug)

2

Active Comparator

Vaginal dinoprostone gel

干预措施: Dinoprostone vaginal gel (Drug)

结局指标

主要结局

spontaneous vaginal delivery

次要结局

  • induction to labour time
  • induction to delivery time
  • rate of failed induction
  • cost per patient
  • rate of caesarean section for fetal heart rate abnormalities
  • 5 minute Apgar score < 7
  • arterial cord blood pH <7.1
  • uterine hyperstimulation

研究者

申办方类型
Other

研究点 (1)

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