Intervention Review

Hyaluronidase for reducing perineal trauma

  1. Fan Zhou1,
  2. Xiao Dong Wang1,*,
  3. Jing Li2,
  4. Gui Qiong Huang1,
  5. Bing Xin Gao1

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 5 FEB 2014

Assessed as up-to-date: 1 APR 2013

DOI: 10.1002/14651858.CD010441.pub2

How to Cite

Zhou F, Wang XD, Li J, Huang GQ, Gao BX. Hyaluronidase for reducing perineal trauma. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD010441. DOI: 10.1002/14651858.CD010441.pub2.

Author Information

  1. 1

    West China Second University Hospital, Sichuan University, Department of Obstetrics and Gynaecology, Chengdu, Sichuan, China

  2. 2

    West China Hospital, Sichuan University, Chinese Cochrane Centre, Chengdu, Sichuan, China

*Xiao Dong Wang, Department of Obstetrics and Gynaecology, West China Second University Hospital, Sichuan University, Renmin Nan Road, Chengdu, Sichuan, 610041, China. drwangxiaodong@126.com. drwangxiaodong@obgyn.com.

Publication History

  1. Publication Status: New
  2. Published Online: 5 FEB 2014

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary

Background

Perineal hyaluronidase (HAase) injection was widely used to reduce the occurrence of perineal trauma, pain and need for episiotomy in the 1950s to 1960s. Reports suggested that the administration of HAase was a simple, low risk, low cost and effective way to decrease perineal trauma without adverse effects.

Objectives

The objective of this review was to assess the effectiveness and safety of perineal HAase injection for reducing spontaneous perineal trauma, episiotomy and perineal pain in vaginal deliveries.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2013), the International Clinical Trials Registry Platform (ICTRP) and the Networked Digital Library of Theses and Dissertations (both on 1 April 2013), and reference lists of retrieved studies. We also contacted relevant organisations.

Selection criteria

Published and unpublished randomised and quasi-randomised controlled trials comparing perineal HAase injection with placebo injection or no intervention in vaginal deliveries.

Data collection and analysis

Two review authors independently assessed trials for inclusion, extracted data and evaluated methodological quality. Data were checked for accuracy.

Main results

The search strategy identified six potentially eligible studies. Two studies were excluded. We included four randomised controlled trials that randomised a total of 599 women (data were available for 595 women).

Two trials (283 women) compared the effects of perineal HAase injection during the second stage of labour with placebo injection and were at low risk of bias. Three trials (one three-armed trial was analysed twice) (373 women) compared the effects of perineal HAase injection during second stage of labour with no intervention and two out of the three trials were at high risk of bias. Data from four trials involving 599 women suggested that perineal HAase injection during second stage of labour had a lower incidence of perineal trauma (average risk ratio (RR) 0.69, 95% confidence interval (CI) 0.50 to 0.95,Tau² = 0.08, I² = 82% compared with women in the control group, but there was no clear evidence of a reduction in the incidence of episiotomy (average RR 0.74, 95% CI 0.43 to 1.29, Tau² = 0.17, I² = 66%), first and second degree perineal lacerations (average RR 0.54, 95% CI 0.38 to 1.33, Tau² = 0.30 , I² = 85%) and third and fourth degree perineal lacerations (RR 0.12, 95% CI 0.01 to 2.13). Data from two trials involving 283 women indicated that there was no clear evidence of a reduction in the incidence of perineal trauma (RR 0.90, 95% CI 0.77 to 1.06, Tau²=1.07, I² = 7%), episiotomy (RR 0.77, 95% CI 0.32 to 1.89, Tau² = 0.27, I² = 54%), first and second degree perineal lacerations (RR 1.08, 95% CI 0.83 to 1.40, Tau² = 1.11, I² = 10%) and third and fourth degree perineal lacerations (RR 0.12, 95% CI 0.01 to 2.13) with perineal HAase injection. Data from three trials involving 373 women suggested that perineal HAase injection during second stage of labour had a lower incidence of perineal trauma (RR 0.61, 95% CI 0.42 to 0.88, Tau² = 0.08, I² = 78%) compared with no intervention, but had no clear effect on in the incidence of episiotomy (RR 0.79, 95% CI 0.44 to 1.42, Tau² = 0.16, I² = 70%) and first and second degree perineal lacerations (RR 0.58, 95% CI 0.31 to 1.10, Tau² = 0.18, I² = 59%). No side effects were reported in the included trials.

No included trials reported on perineal pain and other pre-specified secondary outcomes: perineal trauma requiring suturing; blood loss; dyspareunia; urinary incontinence; faecal incontinence; assisted delivery rate; women's satisfaction; Apgar score less than seven at five minutes and need for admission to special care baby unit.

Authors' conclusions

Perineal HAase injection during second stage of labour had a lower incidence of perineal trauma compared with control or no intervention, but there was no clear evidence of benefit compared with placebo injection. The difference in incidence of perineal trauma may probably be due to bias and confounding in the non-placebo controlled comparison, this result should be interpreted cautiously. The potential use of perineal HAase injection as a method to reduce perineal trauma were yet to be determined as there was no appropriate established dose for HAase, no evidence of follow up, and the number of high-quality trials and outcomes reported were too limited to draw conclusions on its effectiveness and safety. Further rigorous randomised controlled trials are required to evaluate the role of perineal HAase injection in vaginal deliveries.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary

Hyaluronidase for reducing perineal trauma during vaginal birth

Vaginal deliveries are associated with perineal trauma that may be unexpected tears or surgical as a result of episiotomy. Many techniques have been used to prevent perineal trauma, such as antenatal perineal massage or perineum warm compresses. Their effectiveness in reducing perineal trauma has been identified by researchers. Perineal hyaluronidase (HAase) injection was widely used in the 1950s and 1960s to reduce the occurrence of perineal trauma, pain, and the need for episiotomy. The review authors searched the medical literature for randomised controlled trials that compared perineal HAase injection during the second stage of labour with perineal placebo injection or no intervention. They identified four randomised controlled trials involving 599 women (with data available for 595 women). The methodological quality of two out of the four trials included in this review was poor.

Two trials involving 283 women compared the effects of perineal HAase injection with placebo injection during second stage of labour and were at low risk of bias. Three trials (one three-armed trial was analysed twice) with 373 women compared the effects of perineal HAase injection during second stage of labour with no intervention. The overall results showed that perineal HAase injection had a significantly lower incidence of perineal trauma compared with control or no intervention, but there was no difference in the incidence of episiotomy, first and second degree and more severe (third and fourth degree) perineal tears.

There was no clear evidence that HAase injection lowered the incidence of perineal trauma, episiotomy, first and second degree and more severe (third and fourth degree) perineal tears when compared with placebo injection. No side effects were reported in the included trials. Other measures such as perineal pain and other pre-specified secondary outcomes were not measured by the included trials. The difference in the incidence of perineal trauma may be due to bias and confounding in the non-placebo controlled comparison, this result should be interpreted cautiously.

The potential use of this intervention as a method to reduce perineal trauma are yet to be determined as there was no appropriate established dose for HAase, no evidence of follow-up and side effects, and the number of high-quality trials and outcomes reported was too limited to draw conclusions on its effectiveness and safety. Further rigorous randomised controlled trials are required to evaluate the role of perineal HAase injection in vaginal deliveries.