RecruitingACTRN12614000448640

Epidural pain relief and the outcome of labour

A randomised controlled trial of epidural analgesia maintenance during the second stage of labour, in primigravids in preventing of pelvic floor trauma


Sponsor

Prof. Hans Peter Dietz

Enrollment

200 participants

Start Date

Jun 5, 2013

Study Type

Interventional

Conditions

Summary

The aim of this pilot study is to investigate whether pelvic floor muscle relaxation by maintaining the epidural infusion in the second stage of labour may reduce maternal birth trauma. The primary outcome measure will be pelvic floor trauma namely perineal tears, vaginal tears, anal sphincter injuries and levator ani avulsions. Secondary outcome measures include the length of first and second stage of labour, rate of instrumental delivery and caesarean section, and the clinical efficacy (analgesia, motor and sympathetic block) of the two epidural regimes to be tested. RESEARCH HYPOTHESES 1. Maintenance epidural infusion of 0.2% Ropivacaine + Fentanyl 2microgram/ml throughout the second stage of labour can reduce pelvic floor trauma. 2. Maintenance epidural infusion throughout second stage does not increase duration of labour, rate of instrumental and operative delivery. 3. Maintenance epidural infusion throughout second stage of labour provides effective analgesia with a low complication rate.


Eligibility

Sex: FemalesMin Age: 16 Yearss

Inclusion Criteria7

  • Primigravidas or those without previous pregnancies that progressed to 20+ weeks of gestation.
  • Singleton pregnancy.
  • Aiming for vaginal delivery.
  • Participant is able to understand the risks and potential benefits of participating in the study.
  • Participant is willing and fit to provide a written consent.
  • Participant is willing and has the ability to comply with specified follow-up evaluations.
  • Aged 16 and above

Exclusion Criteria4

  • Contraindication to epidural.
  • Neurological disease.
  • Muscular or skin disorder affecting tissue elasticity.
  • Previous pelvic surgery affecting vaginal anatomy.

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Interventions

This study involves patients who wish to have epidural analgesia in labour. All will have 0.2% Ropivacaine & Fentanyl 2microgm in labour. They will be randomised into intervention or non intervention

This study involves patients who wish to have epidural analgesia in labour. All will have 0.2% Ropivacaine & Fentanyl 2microgm in labour. They will be randomised into intervention or non intervention group : Intervention : Epidural infusion maintained / continued throughout 2nd stage.


Locations(1)

Nepean Hospital - Kingswood

NSW, Australia

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ACTRN12614000448640