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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

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Characteristics of included studies [ordered by study ID]
Chatfield 1966

MethodsRandomised double-blind controlled trial; 3-arm design with individual randomisation.


Participants200 women were included. Inclusion criteria: primigravid patients having spontaneous vaginal vertex deliveries. Exclusion criteria: any patient requiring episiotomy for an indication other than a tight or rigid perineum.


InterventionsParticipants were randomly allocated to 1 of the following groups.

Group 1 (n = 57): women received 5 mL sterile normal saline containing 1500 U.S.P units of HAase injected into perineal body at the onset of the second stage of labour.

Group 2 (n = 66): women received 5 mL sterile normal saline injected into perineal body at the onset of the second stage of labour.

Group 3 (n = 77): women received no intervention.


OutcomesPercentage of patients requiring episiotomy; percentage of patients with perineal tears; percentage of patients with intact perineum.


NotesThe perineum was infiltrated at the onset of the second stage of labour. 5 mL of the solution was injected into the perineal body and into the base of the hymen and fourchette. Labour was allowed to continue normally and the decision to perform an episiotomy was made on the usual indications, namely a rigid perineum preventing advance of the presenting part or a tight perineum showing signs of an impending tear.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskTrial reported random allocation to the groups, although the method of sequence generation was not described.

Allocation concealment (selection bias)Low riskThe allocation was supervised by the resident anaesthetic staff who were not concerned with this delivery, and prepared the "blind" solutions for injection.

Selective reporting (reporting bias)Unclear riskThere was insufficient information to permit judgement.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskTrial reported as double-blind. The participants did not know the solution injected.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskTrial reported as double-blind. The obstetrician did not know the identity of the solution injected by him and so was not influenced in his decision to perform episiotomy.

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll patients completed the trial, no participants eliminated from the trial.

Other biasLow riskThe study appeared to be free of other sources of bias.

Colacioppo 2011

MethodsRandomised double-blind controlled trial; 2-arm design with individual randomisation.


Participants160 women were included. Inclusion criteria were: age 18 years or older; no prior record of vaginal birth; term, single, and live fetus; vertex fetal presentation; cervical dilation at least 8 cm on admission to the birth centre; no suspected or confirmed systemic infections or infections of the perineal or vulvovaginal region; and spontaneous birth in a semi sitting position without intradural or extradural anaesthesia.


InterventionsParticipants were randomly allocated to 1 of the following groups.

Group 1 (n = 75 at the end of the trial): women received 5 mL sterile water containing 2000 turbidity-reducing units of HAase injected through the perineal subcutaneous tissue, with 1 mL injected in the centre of the perineum and 2 mL in each of the sides (left and right) at the onset of the second stage of labour.

Group 2 (n = 77 at the end of the trial): women received 5 mL sterile water containing placebo injected through the perineal subcutaneous tissue, with 1 mL injected in the centre of the perineum and 2 mL in each of the sides (left and right) at the onset of the second stage of labour.


OutcomesIntegrity or perineal trauma and its severity.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation by using a computerised, random-numbers table previously generated by the statistician.

Allocation concealment (selection bias)Low riskDouble-blind.

Selective reporting (reporting bias)Unclear riskThere was insufficient information to permit judgement.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble-blind.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskDouble-blind.

Incomplete outcome data (attrition bias)
All outcomes
Low riskA total of 160 women who met the inclusion criteria were recruited and enrolled in the study. None of them declined to participate, and 4 were excluded for the following reasons: 3 did not receive the intervention (2 flasks were broken during use, and 1 was discarded because of accidental introduction of a fragment of the rubber lid during the aspiration of the solution); the fourth was excluded because the providers conducted uterine fundal pressure to help birthing (Kristellermaneuver), and it was thought that this manoeuvre was not standard and may increase perineal trauma. The final sample consisted of 156 participants distributed into 2 groups, with 76 women in the experimental group and 80 in the control group.

Other biasLow riskThe study appeared to be free of other sources of bias.

O'Leary 1965

MethodsRandomised double-blind controlled trial; 2-arm design with randomised selection.


Participants100 term nulliparity or primiparity vaginal deliveries irrespective of age or nationality.


InterventionsIntervention group: 5-10 mL prepared HAase contained 750-1550 turbidity-reducing units of HAase (Wydase) injected into the perineal body, hymen, and any previous episiotomy scars before delivery.

Control group: no intervention.


OutcomesEpisiotomy; perineum lacerations.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod of sequence generation was not described.

Allocation concealment (selection bias)Unclear riskMethod of concealment was not described.

Selective reporting (reporting bias)Unclear riskThere was insufficient information to permit judgement.

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not possible to blind the intervention for the participants.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported as blinded. Different interventions were used: HAase injection or no intervention.

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll patients completed the trial, no participants eliminated from the trial.

Other biasLow riskThe study appeared to be free of other sources of bias.

Scarabotto 2008

MethodsRandomised controlled trial; 2-arm design with individual randomisation.


Participants139 women were included. Inclusion criteria: between 15 and 35 years of age; no previous record of vaginal birth; single, live fetus, vertex fetal presentation; spontaneous delivery in left lateral position; no intravenous oxytocin infusion during the first and second stages of labour; no previous perineal treatment during gestation; and no suspected or confirmed systemic infections or infections of the perineal or vulvo-vaginal region. Additionally, upon admission to the birth centre, study participants had a uterine height no greater than 36 cm, cervical dilatation of 8 cm or less, and intact amniotic membranes. Cases requiring medical interventions were excluded.


InterventionsParticipants were randomly allocated to 1 of the following groups.

Group 1 (n = 71 at the end of the trial): women received 5 mL sterile water containing 2000 turbidity-reducing units of HAase injected 1 mL in the centre of the perineum and 2 mL in each of the sides in the shape of a fan during the second stage of labour.

Group 2 (n = 68 at the end of the trial): no intervention.


OutcomesIntact perineum, episiotomy, first and second degree laceration.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation by computerised random numbers table previously generated by the statistician.

Allocation concealment (selection bias)High riskNo concealment.

Selective reporting (reporting bias)Unclear riskThere was insufficient information to permit judgement.

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not possible to blind the intervention for the participants.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported as blinded. Different interventions were used: HAase injection or no intervention.

Incomplete outcome data (attrition bias)
All outcomes
Low riskIn total, 160 women who met the eligibility criteria were enrolled in the study. During the first stage of labour, 9 women were excluded following intravenous infusion of oxytocin and 11 were excluded because of the need to perform caesarean delivery. During the second stage, 1 woman was excluded because of the use of forceps to deliver the fetus. The final sample consisted of 139 women distributed into 2 groups, with 71 women in the intervention group and 68 in the control group.

Other biasLow riskThe study appeared to be free of other sources of bias.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Giri 1969This study aimed at studying the effects of HAase injection before episiotomy on local anaesthesia oedema and pain, sepsis and union of the episiotomy wound, and compared these effects with those of a control series.

Nashar 2011Aimed at determining the effectiveness of Cikatridina spray on aiding healing of episiotomy and spontaneous perineal ruptures after normal and operative vaginal delivery. This study did not compare the injection of hyaluronidase versus placebo or no intervention.

 
Comparison 1. HAase injection versus control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Incidence of perineal trauma4595Risk Ratio (M-H, Random, 95% CI)0.69 [0.50, 0.95]

 2 Incidence of episiotomy4595Risk Ratio (M-H, Random, 95% CI)0.74 [0.43, 1.29]

 3 Incidence of first and second degree perineal lacerations4595Risk Ratio (M-H, Random, 95% CI)0.71 [0.38, 1.33]

 4 Incidence of third and fourth degree perineal lacerations4595Risk Ratio (M-H, Fixed, 95% CI)0.12 [0.01, 2.13]

 
Comparison 2. HAase injection versus placebo injection

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Incidence of perineal trauma2279Risk Ratio (M-H, Fixed, 95% CI)0.90 [0.77, 1.06]

 2 Incidence of episiotomy2279Risk Ratio (M-H, Random, 95% CI)0.77 [0.32, 1.89]

 3 Incidence of first and second degree perineal lacerations2279Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.83, 1.40]

 4 Incidence of third and fourth degree perineal trauma2279Risk Ratio (M-H, Random, 95% CI)0.12 [0.01, 2.13]

 
Comparison 3. HAase injection versus no intervention

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Incidence of perineal trauma3373Risk Ratio (M-H, Random, 95% CI)0.61 [0.42, 0.88]

 2 Incidence of episiotomy3373Risk Ratio (M-H, Random, 95% CI)0.79 [0.44, 1.42]

 3 Incidence of first and second degree perineal lacerations3373Risk Ratio (M-H, Random, 95% CI)0.58 [0.31, 1.10]

 4 Incidence of third and fourth degree perineal trauma3373Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]