None listed
Conditions
Brief summary
We will test to see if the addition of sterile water injections for the relief of back pain in labour to standard pharmacological (nitrous oxide gas, narcotics, epidural) and non-pharmaclogical analgesic options ( shower, water immersion, massage, heat, aromatherapy, TENS) will affect birth outcomes, specifically the rates of caesarean section.
Interventions
Women with back pain during first stage labour, assessed by visual analogue scale as = 7 will receive 0.1 – 0.3 millilitres of sterile water for injection. The exact volume injected is determined by visualisation of the resulting blister or bleb by the administering clinician. The injection is given using of one-millilitre syringes and 23 gauge needles, one injection into four anatomical points surrounding the Michaelis rhomboid over the sacral area: two over the posterior superior iliac spines
Women with back pain during first stage labour, assessed by visual analogue scale as = 7 will receive 0.1 – 0.3 millilitres of sterile water for injection. The exact volume injected is determined by visualisation of the resulting blister or bleb by the administering clinician. The injection is given using of one-millilitre syringes and 23 gauge needles, one injection into four anatomical points surrounding the Michaelis rhomboid over the sacral area: two over the posterior superior iliac spines (PSIS) and the remaining two at two centimetres posterior, and one centimetre medial, to the PSIS respectively. Women may receive repeat injections upon request once the VAS is again = 7. Repeat injections will be of Sterile Water for injection. There is no maximum amount of injections that women may receive during their labour.
Sponsors
Mater Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Outcome results
None listed