None listed
Conditions
Brief summary
Access to safe, effective pain relief is a hallmark of high quality maternity care. For women in labour the pharmacological options for pain relief have changed little in over 50 years. The choices of opioids and nitrous oxide have been reported as having a limited effect on labour pain and undesirable side effects. Epidurals provide excellent analgesia, however they severely limit mobility in labour, require advanced medical skills, close monitoring of mother and baby and can increase the risk of further medical interventions in birth. This trial will test the novel, off-label use of sterile water injections (six injections of 0.1 - 0.3 millilitres each) administered into the abdominal skin of laboring women to relieve contraction pain. Our research team’s previous work has provided definitive evidence for the effectiveness of water injections to relieve back pain (not contraction pain) in labour for approximately two hours. The injections can be repeated with no side effects. However, injections given into the back have no effect on abdominal contraction labour pain. Our proposed trial will use a randomised, double blind, placebo-controlled design to test the safety and analgesic effectiveness of water injections to relieve labour contraction pain. We will conduct survey and qualitative studies to assess satisfaction, acceptability and impact on the birth experience alongside a cost-effectiveness study. If successful, our study will provide a new option for labour pain relief that is safe, effective, cost efficient, only requiring skills available to many health care providers and ideal for women wanting to avoid the side effects of other pharmacological analgesic options. The common availability of sterile water and the simplicity of administration would make the procedure useful in regional areas and settings (e.g. homebirth), where other pharmacological analgesic options such as epidurals may not be available, and women in countries with developing health systems.
Interventions
Women with abdominal contraction pain during stage labour, assessed by visual analogue scale as equal to or greater than 6 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. Injections can be administered by a midwife or doctor. The injection is given intradermally using of one-millilitre syringes and 23 gauge needles. One injection into six anatomical points
Women with abdominal contraction pain during stage labour, assessed by visual analogue scale as equal to or greater than 6 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. Injections can be administered by a midwife or doctor. The injection is given intradermally using of one-millilitre syringes and 23 gauge needles. One injection into six anatomical points; at the fundus, part way between the fundus an umbilicus, part way between the umbilicus and the suprapubis, laterally (left and right) of the suprapubis. Women may receive up to four repeat treatments upon request once the VAS is again equal to or greater than 6. The overall duration of the intervention is 5 treatments over the course of the woman's labour. Repeat injections will be given in the same six anatomical sites as the initial treatment. There is no minimum time required between the initial or repeat doses. The case report form will collect data on the exact number of injections given at each treatment and reasons is less or more than six. Normal saline 0.9% is being used as a placebo. As normal saline is isotonic it does not result in the same degree of injection pain as sterile water and provides little if any analgesic effect.
Sponsors
University of Queensland
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
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
In labour (spontaneous or induced) Are equal to or greater than 16 years of age Have a term singleton pregnancy (between 37 and 42 weeks gestation) Have a fetus in a cephalic (head down) presentation Experience abdominal labour pain assessed by visual analogue scale VAS as equal to or greater than 6 Are able to provide informed consent
Exclusion criteria
Multiple pregnancy Malpresentation (breech, transverse, shoulder) Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia Serious medical condition of pregnancy (e.g. unstable hypertension, insulin controlled diabetes)
Outcome results
None listed