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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000448640

Acronym

Nil

Enrollment

200

Registered

2014-05-01

Start date

2013-06-05

Completion date

2016-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 group : Intervention : Epidural infusion maintained / continued throughout 2nd stage.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Primigravidas or those without previous pregnancies that progressed to 20+ weeks of gestation. 2. Singleton pregnancy. 3. Aiming for vaginal delivery. 4. Participant is able to understand the risks and potential benefits of participating in the study. 5. Participant is willing and fit to provide a written consent. 6. Participant is willing and has the ability to comply with specified follow-up evaluations. 7. Aged 16 and above

Exclusion criteria

1. Contraindication to epidural. 2. Neurological disease. 3. Muscular or skin disorder affecting tissue elasticity. 4. Previous pelvic surgery affecting vaginal anatomy.

Outcome results