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

BackgroundApproximately 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/designThis 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.DiscussionMost 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.Trial registrationClinicalTrials.gov: NCT01937546.

The effect of maneuvers for shoulder delivery on perineal trauma: a randomized controlled trial

“…We followed the CONSORT recommendations for reporting randomized, controlled, clinical trials involving nonpharmacologic treatment . Further details of the study methods and design have been published previously .…”

“…Because of this risk of emergency cesarean delivery and the risk of drop‐outs, 650 women were included in the trial. To ensure that one intervention did not cause markedly more perineal trauma, interim analyses were performed by a data monitor not otherwise involved in the trial after the first year and consecutively thereafter every 6 months as previously described .…”

Effect of second stage perineal warm compresses on perineal pain and outcome among primiparae

“…Possible deleterious effects include painful intercourse, urinary and fecal incontinence, and persistent perineal pain. [12,13] Where, at 8 weeks after birth, 22% of new mothers report continued perineal pain, and for some women, pain may persist for a year or longer. [14] Perineal preservation and comfort during the second stage of labor are important goals in the practice of most midwives, as midwives and obstetricians should be aware that perineal trauma is associated with significant short-and long-term morbidity for these finding the ways to improve women's comfort during the second stage would be beneficial.…”