ICARIS Trial
Research type
Research Study
Full title
Impact on Caesarean Section Rates Following Injections of Sterile Water
IRAS ID
166447
Contact name
Sally Collins
Contact email
Sponsor organisation
Mater Research Institute University of Queensland
Eudract number
2014-004343-12
Clinicaltrials.gov Identifier
No ACTRN12611000221954 , Australian and New Zealand Clincial Trials Registry
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
The aim of this study is to determine if the use of injections of sterile water (SWI) into the lower back to relieve back pain in labour, may also reduce the caesarian section (CS) rate. In 2009 Canadian and Dutch researchers conducted a meta-analysis of trials designed to test the effectiveness of SWI to relieve back pain in labour. The meta-analysis included eight trials involving 828 women and found a CS rate of 4.6% in the SWI group and 9.9% in the control groups suggesting that SWI may have a role in reducing the CS rate. The rate of CS has risen annually in the UK reaching 25% of all births in 2011. Having one CS often results in repeat CSs and major obstetric complications in subsequent births, including reduced fertility, increased risk of ectopic pregnancy and spontaneous miscarriage. Babies born by CS are more likely to need admission to neonatal intensive care nurseries and have an increased risk of neonatal mortality. The CS rate also imposes a significant cost on health care systems, two to three times that of a vaginal birth. We will conduct a double blinded randomised controlled trial to compare SWI to a placebo of normal saline. We will invite women giving birth at the Oxford University Hospital, who request analgesia for back pain in labour, to participate in the study. Women will also have access to all other forms of analgesia. During labour, visual analogue pain scores (VAS) will be assessed prior to, and up to 2 hours following the procedure. Following birth, data on CS rates, other birth outcomes, analgesic use, and neonatal outcomes will be collected. With a sufficiently large sample of we will provide robust evidence for the impact of SWI on birth outcomes, such as CS.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0509
Date of REC Opinion
7 Oct 2015
REC opinion
Further Information Favourable Opinion