Hyaluronidase for reducing perineal trauma.
Author(s): Zhou F(1), Wang XD, Li J, Huang GQ, Gao BX.
Affiliation(s): Author information:
(1)Department of Obstetrics and Gynaecology, West China Second University Hospital,
Sichuan University, Renmin Nan Road, Chengdu, Sichuan, China, 610041.
Publication date & source: 2014, Cochrane Database Syst Rev. , 2:CD010441
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SELECTION CRITERIA: Published and unpublished randomised and quasi-randomised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.
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