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临床试验/NCT03730220
NCT03730220已完成不适用

Induction of Labour in Norway: a Pilot for a Prospective National Audit

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 1,846 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,846
试验地点
1
主要终点
Caesarean rate

研究概览

简要总结

The worldwide rate of induction of labour has been steadily increasing over the last 15 years, a trend that is reflected in Norway.

The overall aim of this study is to identify disparities between delivery departments in Norway in regards to:

  1. The overall rate of labour induction
  2. Main indication for the induction of labour.
  3. Induction methods used and protocols followed
  4. Maternal and fetal outcomes in induced births

Methods:

Observational study. Registration of induction indication, methods and outcomes in induced women. Data will be collected prospectively during a period of 4 months from 21 Norwegian delivery units using a web-based standardized case record form.

详细描述

In 2000 the Norwegian national induction rate was 8.8% of all births, but this increased to 21.8% in 2016. The regional induction rate varies between counties, varying from 17.7% of all births in Nordland to 24.0% in Rogaland. Individual units could have an even wider variation. There are reports of a high rate of induction in primiparous women. In some units, local audits have noted that in 2016, over 27% of primiparous women had their labour induced. Labour inductions in primiparous women (Robson group 2a) may be associated with an increased likelihood of caesarean sections and operative vaginal delivery. An increased caesarean rate in primiparous women will have implications for subsequent pregnancies. In Hammerfest Hospital, the caesarean section rate in Robson group 2a was 37% in 2016.

In Norway, induction of labour is offered in approximately 50 obstetric units. There are national guidelines available for the induction of labour from the Norwegian Gynaecological Society and from the Department of Health. , These guidelines are not categorical and leave the decision for the specific method, or regimen for labour induction, up to the attending gynaecologist or local departments. Thus, the national protocols between departments vary considerably and women living in different regions of Norway do not have the same options for induction of labour.

The Norwegian situation reflects the international situation where multiple induction protocols exist. There is no consensus regarding the medical criteria for the identification of women for induction of labour, nor the induction methods or protocols used.

Aim

The overall aim of this study is to identify disparities between delivery departments in Norway in regards to:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Induced women with no previous vaginal delivery
  • Gestational age from 23+0 weeks
  • Viable pregnancy at time of inclusion

排除标准

  • Previous vaginal delivery

结局指标

主要结局

Caesarean rate

时间窗: Throughout the study period of 3 months

Caesarean rate in induced women

次要结局

  • Uterine tachysystole during labour(From start of labour as defined by opening of partograph until time of birth of baby)
  • Time from induction to delivery(From start of medication/balloon until time of birth of baby)
  • Indication for induction of labour(Throughout the study period of 3 months)
  • Induction method used(Throughout the study period of 3 months)
  • Composite infant outcome(From time of delivery until time of discharge of patient from maternity unit)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingvil Krarup Sørbye

Consultant

Oslo University Hospital

研究点 (1)

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