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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether keeping the epidural working fully during the pushing phase of labour (second stage) reduces tearing and injury to the pelvic floor muscles. Epidurals relax muscles, which might mean less trauma to the birth canal. Researchers will measure rates of tears, muscle injuries, length of labour, and delivery method. You may be eligible if: - You are 16 years of age or older - You are pregnant for the first time (or have not had a previous pregnancy beyond 20 weeks) - You are expecting a single baby - You are planning a vaginal birth - You are able to understand and give written consent You may NOT be eligible if: - You have a medical reason why you cannot have an epidural - You have a neurological condition - You have a muscle or skin disorder that affects tissue elasticity - You have had previous pelvic surgery that changed the anatomy of the vaginal area Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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