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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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, i
Sponsor: Holbaek Sygehus

Current Primary Outcome: Number of patients with perineal tears [ Time Frame: perineal tears are evaluated within 1 hour of delivery ]

Any perineal tear requiring suturing


Original Primary Outcome: Number of patients with perineal tears [ Time Frame: perineal tears are evaluated within 1 hour of delivery ]

Perineal tear of grade I-IV


Current Secondary Outcome:

  • pH in umbilical artery [ Time Frame: Evaluated within 5 minutes of delivery ]
    Arterial pH in the umbilical artery
  • apgar score [ Time Frame: 5 minutes ]
    Apgar-score 5 minutes after delivery
  • neonatal birth trauma [ Time Frame: 2 hours ]
    Neonatal birth trauma including fractures of the clavicle and humerus, and brachial plexus injury.
  • Post partum bleeding [ Time Frame: 2 hours post partum ]
    postpartum bleeding in millilitres evaluated 2 hours after birth
  • the perineal injury subtypes [ Time Frame: Within 1 hour after delivery ]
    Labia laceration, Perineal tear grade I-IV or episiotomy.


Original Secondary Outcome:

  • pH in umbilical artery [ Time Frame: Evaluated within 5 minutes of delivery ]
    Arterial pH in the umbilical artery
  • apgar score [ Time Frame: 10 minutes ]
    Apgar-score 10 minutes after delivery
  • fetal injury [ Time Frame: 2 hours ]
    Fetal injury acquired during birth, eg. fractured claviculae, fractured humerus, brachial plexus injury


Information By: Holbaek Sygehus

Dates:
Date Received: August 30, 2013
Date Started: January 2013
Date Completion:
Last Updated: July 23, 2015
Last Verified: July 2015