Impact on Caesarean Rates following Injections of Sterile Water (ICARIS) – A randomised controlled trial.

Not Applicable

• Conditions: abour and birth; Labour and birth; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12611000221954
• Lead Sponsor: Mater Health Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 1866

Inclusion Criteria

Term pregnancy (between 37 and 42 weeks gestation)
Singleton pregnancy
Cephalic presentation
Back pain assessed by VAS as =7 when women request analgesia for backpain
Able to give informed consent

Exclusion Criteria

Multiple pregnancy
Malpresentation (breech, transverse, shoulder)
Back pain assessed by VAS < 7 when women request analgesia for backpain
Any major complications that could cause problems with bleeding at the injection site eg. thrombocytopenia or any clotting abnormality.
Standard exclusion criteria, based on clinical assessment to intradermal injections, will apply, including infection or inflammation involving the proposed injection sites.

Study & Design

• Study Type: Interventional
• Study Design: Not specified