title: The effect of primary delivery of the anterior compared with the posterior shoulder on perineal trauma: a study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Approximately 85% of vaginal deliveries are accompanied by perineal trauma. The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared with the posterior shoulder during vaginal birth. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma.
  
  
  METHODS
  This is a single-centre, randomized controlled trial, with computer-generated randomization in a 1:1 allocation ratio. Women planning their first vaginal delivery (n = 650) are randomized to primary delivery of either the anterior or posterior shoulder. The primary outcome is any perineal trauma. Additional outcomes are the perineal injury subtypes, postpartum bleeding, umbilical artery pH, Apgar score at 5 minutes and any neonatal birth trauma. Perineal trauma is assessed by a midwife or doctor blinded to the method of shoulder delivery. All midwives are trained in the two methods of shoulder delivery and in the grading of perineal tears. The trial is being undertaken at a Danish community hospital with 1,600 yearly deliveries. Data will be analyzed according to the intention-to-treat principle. Recruitment started in January 2013 and the trial is planned to proceed for 24 months.
  
  
  CONCLUSIONS
  Most delivery assistance techniques are based on tradition and heritage and lack objective evidence. This trial provides an example of how vaginal delivery techniques can be evaluated in a randomized controlled trial. The results of this trial will clarify the role that delivery of the shoulders has on perineal trauma and thereby provide knowledge to recommendations on birthing technique.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01937546.
authors.forename: Hanne
authors.initials: H
authors.lastname: Willer
authors.affiliation: Department of Obstetrics and Gynaecology, University of Copenhagen, Holbæk Hospital, Holbæk, Denmark. aabakke@gmail.com.
authors.forename: Anna J M
authors.initials: AJ
authors.lastname: Aabakke
authors.forename: Lone
authors.initials: L
authors.lastname: Krebs
mesh_terms: D002985:Clinical Protocols; D036861:Delivery, Obstetric / Q000009:adverse effects*; D004992:Ethics, Medical; D005260:Female; D006801:Humans; D017063:Outcome Assessment, Health Care; D010502:Perineum / Q000293:injuries*; D011247:Pregnancy; D011446:Prospective Studies; D012782:Shoulder