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临床试验/NCT01263158
NCT01263158已完成不适用

Labour Augmentation by Means of Oxytocin - Obstetric Outcome and Women's Experiences

Göteborg University2 个研究点 分布在 1 个国家目标入组 2,072 人开始时间: 1998年10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
2,072
试验地点
2
主要终点
Mode of delivery (spontaneous vaginal, instrumental vaginal or caesarean delivery)

研究概览

简要总结

Slow labour progress is common in nulliparous women and is associated with childbirth complications and negative birth experiences. Oxytocin augmentation is widely used to treat slow labour despite associated risks for the fetus. An ongoing debate concerns whether oxytocin should be administered directly or postponed after arrested labour. The overall aim is to study labour progress in healthy nulliparous women and to compare childbirth outcomes and experiences in women randomised to expectant versus early oxytocin augmentation for slow labour progress.

The hypothesis is that it is to early to start oxytocin treatment when labour progress has been slow for 2 to 3 hours in healthy women having their first baby and therefore beneficial for childbirth outcomes to postpone oxytocin for another 3 hours. In this randomised controlled trial nulliparous women with a normal pregnancy, spontaneous onset of active labor at term, and a cervical dilatation of 4 - 9 centimetres on admission to the delivery ward were included (n=2,072). All women whose labour did not progress after amniotomy (n=630) were randomly allocated either to labour augmentation by oxytocin infusion (Early oxytocin, n=314) or to postponement of oxytocin augmentation for another three hours (Expectant, n=316). One month postpartum the women received a postal questionnaire concerning their experiences of labour and birth. All participating women gave their informed consent. Maternal and neonatal outcomes like mode of delivery, postpartum haemorrhage, perinatal lacerations, low Apgar score, need of neonatal intensive care and maternal experiences of childbirth were compared between the randomised groups.

详细描述

In contemporary handling of labouring women in the western world, it has become extremely common to intervene through "active" or disciplined" management (Enkin et al., Widela et al., Gerdhardstein et al., Frigoletto et al). It is a widespread routine - and potential side effects will therefore have a great impact. The use of the hormone oxytocin to enhance and speed up labour is the most common method, but the sparse scientific data regarding its effect are inconsistent and mostly demonstrate uncertain and sometime side effects (Thornton & Lilford, Frazer 1994, 1998, Cammu & Van Eeckhout).

The effects, when evaluated, are short-term effects of maternal (obstetric) and fetal outcomes. The studies performed have mostly aimed to investigate whether the active management can reduce the rate of caesarean sections. However, in a meta-analysis of four randomised studies of the effects of oxytocin as intervention in spontaneous labour (Frazer), no significant reduction in the incidence of caesarean section, instrumental deliveries, and use of analgetics or hyper stimulation of labour was found. The only statically significant differences were in side effects: an increased incidence of discomfort and of pain in the group given oxytocin. In this meta-analysis, no significant differences in fetal conditions between the groups were found.

Only one of the studies found sought the women's view on the augmentation procedures (Enkin). Over half of the women who were interviewed, said that the oxytocin treatment was unpleasant and indicate that they would like to try without the drug when giving birth the next time. Over 80% felt that it had increased the amount of pain that they had experienced.

In spite of poor evidence of benefits, around half of birth giving women in Sweden receive oxytocin during labour and in some other countries, far more than that (Waldenström, O'Driscoll, Enkin). It has become the standard care of treating labours with slow progress. According to an investigation by the Swedish National Board of Health and Welfare (Socialstyrelsen 1996), the indications for oxytocin use and the amounts administered are not systematically recorded, and the assessments of its effects are even less well recorded. This makes evaluation by using existing documents very unreliable, and randomised controlled studies.

Aims of the study

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparity Normal pregnancy 37+0 - 41+6 weeks Single foetus Cephalic presentation Spontaneous onset of active labour Informed consent

排除标准

  • Prelabour rupture of membranes Serious maternal disease Fetal intrauterine death

结局指标

主要结局

Mode of delivery (spontaneous vaginal, instrumental vaginal or caesarean delivery)

次要结局

  • Sphincter lacerations
  • Maternal experiences of childbirth
  • Postpartum haemorrhage
  • Need of neonatal intensive care

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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