A comparison of two versus four sterile water injections for the relief of back pain in labour: A randomised controlled equivalence trial

Not Applicable

• Conditions: Women experiencing significant back pain in labour; Reproductive Health and Childbirth - Childbirth and postnatal care; Anaesthesiology - Pain management

• Registration Number: ACTRN12613000863730
• Lead Sponsor: niversity of Queensland / Midwifery Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-05
• Study Completion: 2020-04-06
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 242

Inclusion Criteria

Women at term (between 37 and 42 weeks)
Nulliparous or multiparous
Singleton pregnancy
Cephalic presentation
First stage labour (spontaneous or induced)
No previous analgesia
Back pain assessed by VAS as greater than or equal to 7
Ability to give informed consent.

Exclusion Criteria

Gestation < 37 weeks
Multiple pregnancy
Malpresentation (Breech Transverse etc.)
Second stage labour
Pharmacological analgesia less than 4 hours prior to Sterile Water Injections (SWI)
Back pain assessed by VAS < 7
Any medical complications of pregnancy or labour ( type 1 diabetes hypertension requiring intrapartum management).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in pain measured by Visual Analogue Pain Scale (VAS)[30 minutes following injections]

Secondary Outcome Measures

Name	Time	Method
pain associated with procedure measured by VAS[Immediately following injections];Pain score of backpain measured by VAS[30 minutes following injections];Pain score of backpain measured by VAS[60 minutes following injections];Pain score of backpain measured by VAS[90 minutes following injections];Pain score of backpain measured by VAS[120 mintues following injections];Patient satisfaction with analgesic effect assesed using Patient Satisfaction Questionnaire[Postpartum];Other analgesia used during labour, data taken from medical records[Postpartum]