Impact on Caesarean Section Rates Following Injections of Sterile Water

Phase 1

• Conditions: Back pain in labour and childbirth; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2014-004343-12-GB
• Lead Sponsor: Mater Research Institute University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1866

Inclusion Criteria

Women who:
•In labour
•Are = (equal to or greater than) 18 years of age
•Have a term singleton pregnancy (between 37 and 42 weeks gestation)
•Have a fetus in a cephalic (head down) presentation
•Experience back pain assessed by visual analogue scale VAS as = 7 when women request analgesia for back pain
•Are able to provide informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Multiple pregnancy
•Malpresentation (breech, transverse, shoulder)
•Previous CS
•Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified