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临床试验/NCT01261689
NCT01261689已完成不适用

The Randomised Epidural Analgesia in Term Delivering Women Trial

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 488 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
488
试验地点
2
主要终点
instrumental delivery

研究概览

简要总结

* The objective of the study: to assess the impact of a proactive policy of offering EA at the start of labour as compared to a restrictive policy or care as usual.

* Study design: It concerns a multicentre randomised open label trial.

* Study population: Term nulliparous and multiparous women with a child in cephalic presentation, and without contraindications for vaginal labour or EA.

* Intervention: Women will be allocated to the EA group or the care-as-usual group. In the EA group, women are given an EA as soon as they are in labour. In the care-as-usual (restrictive) group, women receive pain relief only on their explicit request.

详细描述

Labour pain can be regarded as one of the most serious kinds of pain.In many countries labour pain is effectively treated on request of the labouring woman. In The Netherlands, labour pain has been traditionally approached conservatively. However, this policy is rapidly changing into effective treatments on request.Epidural analgesia (EA) has been proven to be one of the most effective methods of pain relief during labour.In addition, EA leads to increased patient satisfaction. Compared with other (or no) methods of pain relief, however, EA is associated with more use of oxytocin, a longer second stage of labour, and more instrumental vaginal deliveries. Other possible adverse effects in labouring women during EA are hypotension, motor block, urine retention, and fever. These complications and adverse effects are possible reasons, why EA is still not widely advised and accepted in The Netherlands.However, the question whether these adverse effects are caused by the EA, or that the observations are biased is still unanswered. The studies that have been performed to address these items are not applicable to the general population of women delivering a child, as they were all performed in women in strong need of pain relief.Generally, the need for pain relief is increased when progression of labour is difficult, for example in case of a relatively great child or ineffective contractions, especially in nulliparous women. It is well known that in this group of labouring women, also without EA, obstetrical problems are increased. On the other hand, a multivariable analysis of factors that are associated with an arrest of labour indicates, that women with EA have a decreased risk of arrest of labour. At present, randomized controlled trials that study the obstetrical consequences of EA in nulliparous women without strong need of pain relief are lacking. Besides that, only a few studies have extensively looked at the preference of women for EA. It seems that parity status, the fear of the side effects of EA, pain catastrophizing, the desire to have a pain-free childbirth, positive experiences with EA of family and friends influence the odds of choosing EA. So, based on the international literature, the ongoing increase in The Netherlands of EA's on maternal request during delivery may result in more obstetrical problems and increased health costs. Of course a change in pain treatment surrounding birth will have an impact for the women in labour, as well as for the society. On the one hand the costs of care are likely to increase due to EA, as EA is more expensive and might lead to an augmentation of medical complications, on the other hand in the EA-group women will have less pain while in labour as compared to the non-EA group. The question remains, whether this can be counteracted by a proactive policy of offering EA before explicit maternal request for pain relief in the absence of obstetrical problems. It is assumed, that a proactive policy might result in effective pain reduction and increased patient satisfaction without increased obstetrical problems and without increased health costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • be 18 years or older
  • bear a singleton child in cephalic presentation
  • be under supervision (second line) for their pregnancy in one of the participating centres.
  • have no contraindications for vaginal labour
  • have no contraindications for EA: Use of coumarines LMWH in therapeutic dose LMWH in prophylactic dose, less than 10 hours ago Thrombocytes < 80 x 109/ L Use of thrombocytes aggregation inhibitors or anamnestic increased bleeding tendency Blood clotting disorders Allergy for used anesthetics Spine disorders or back infection

排除标准

  • be younger than 18 years
  • bear twin pregnancy
  • have contraindications for vaginal labour
  • have contraindications for EA
  • referral by midwife during labour (first line)

研究组 & 干预措施

Epidural analgesia

Active Comparator

Women will be allocated to the EA group. In the EA group, women are given an EA as soon as they are in labour.

干预措施: Ropivacaine/ Sufentanil according to local hospital protocol (Drug)

Care as-usual pain treatment

Other

Women will be allocated to the care-as-usual group. In this care-as-usual(restrictive) group, women receive pain relief only on their explicit request. If necessary epidural analgesia.

干预措施: Care-as usual pain treatment (Other)

结局指标

主要结局

instrumental delivery

时间窗: at labour

The primary outcome measure is the risk of an instrumental delivery (vaginal instrumental delivery and secondary cesarean sections)

次要结局

  • Neonatal condition(Postpartum)
  • Neonatal antibiotic use(Postpartum)
  • Neonatal admission(postpartum)
  • Maternal pain catastrophizing(Antepartum)
  • Beliefs about epidural(antepartum)
  • Maternal childbirth experience(6 weeks postpartum)
  • start labour(during labour)
  • Oxytocin use(During labour)
  • Quality of life(antepartum, 6 weeks postpartum)
  • Duration ruptured membranes(Labour)
  • Internal digital vaginal examinations(Labour)
  • Maternal fever(During labour)
  • Maternal antibiotic use(During labour)
  • Duration of second stage of labour(labour)
  • Obstetric complications(labour)
  • Epidural related complications(labour and postpartum)
  • Duration epidural(labour)
  • Maternal hypotension(Labour)
  • Motor block(Labour)
  • Other use of anaesthetics(Labour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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