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临床试验/NCT01937546
NCT01937546已完成不适用

The Effect of Primary Delivery of the Anterior Compared With the Posterior Shoulder on Perineal Trauma: a Randomized Controlled Trial

Holbaek Sygehus1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
650
试验地点
1
主要终点
Number of patients with perineal tears

研究概览

简要总结

It is unknown if primary delivery of the anterior or the posterior shoulder causes less perineal tear. The objective of this trial is to evaluate the incidence and degree of perineal trauma after primary delivery of the anterior shoulder compared to primary delivery of the posterior shoulder during vaginal birth in primiparous women in a randomized controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma.

详细描述

Background Approximately 85% of vaginal deliveries are accompanied by trauma to the genital tract, with a higher risk at the first compared to subsequent vaginal births [1,2]. Among primipara with vaginal deliveries, 86% sustain a vaginal or perineal tear, and 77% require suturing of a lesion [1,3].

Birth trauma is associated with both short- and long-term morbidity, including pain, discomfort, dyspareunia, and fecal incontinence, and perineal trauma may cause social problems and affect the psychological well-being of the mother [1,4]. The level of postpartum morbidity is related to the degree of trauma [5,6], and studies of preventive measures are therefore of interest.

Genital tract traumas are classified into subtypes according to the location and severity of the lesion. Most studies have evaluated the risk factors for 3rd- and 4th-degree perineal tears that include the anal sphincter complex, the so-called obstetric anal sphincter injuries (OASIS). Predisposing factors are increasing maternal age, heavier birthweight, longer duration of the second stage of labour, oxytocin augmentation, occiput posterior position, and instrumental delivery [7-9]. The risk increases with the number of different risk factors [9]. Protective factors are previous vaginal delivery, epidural analgesia, and multiparity [7-9]. Several perineal management techniques used during delivery have been studied, and a recent Cochrane review concluded that warm compresses and perineal massage seem to reduce the risk of OASIS [4]. The introduction of an interventional perineal protection programme also seems to reduce the incidence of OASIS [10-12].

Leading textbooks recommend primary delivery of the anterior shoulder by gentle traction if the shoulders are not delivered spontaneously [13,14]. However, if shoulder dystocia occurs, the recommended manoeuvres are primary delivery of the posterior arm or primary delivery of the posterior shoulder, with the woman positioned on her hands and knees (Gaskin's manoeuvre) [15,16]. A computer-simulated trial of the manoeuvres used during shoulder dystocia found that primary delivery of the posterior arm caused an 80% reduction in the delivery force and a 70% reduction in stretch to the brachial plexus [17]. Primary delivery of the posterior shoulder could therefore be of advantage during uncomplicated deliveries, but, to the knowledge of the authors, various methods of shoulder delivery have never been studied previously.

The objective of this trial is to evaluate the incidence and degree of perineal trauma after primary delivery of the anterior shoulder compared to primary delivery of the posterior shoulder during vaginal birth in primiparous women in a randomized controlled trial. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •nullipara
  • •primipara with previous cesarean section

排除标准

  • •Multipara
  • •Twin pregnancies
  • •Nullipara with elective cesarean section
  • •Preterm delivery before 35 gestational weeks
  • •Breech delivery
  • •Acute cesarean section

研究组 & 干预措施

Anterior shoulder

Active Comparator

Primary delivery of the anterior shoulder of the fetus

干预措施: Primary delivery of anterior shoulder (Procedure)

Posterior shoulder

Experimental

Primary delivery of the posterior shoulder of the fetus

干预措施: Primary delivery posterior shoulder (Procedure)

结局指标

主要结局

Number of patients with perineal tears

时间窗: perineal tears are evaluated within 1 hour of delivery

Any perineal tear requiring suturing

次要结局

  • pH in umbilical artery(Evaluated within 5 minutes of delivery)
  • apgar score(5 minutes)
  • neonatal birth trauma(2 hours)
  • Post partum bleeding(2 hours post partum)
  • the perineal injury subtypes(Within 1 hour after delivery)

研究者

发起方
Holbaek Sygehus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanne Willer

Midwife

Holbaek Sygehus

研究点 (1)

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