A comparison of two versus four sterile water injections for the relief of back pain in labour: A randomised controlled equivalence trial

For women in labour with back pain does a two sterile water injection technique compared to a four injection result is comparable levels of analgesia

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000863730

Enrollment

242

Registered

2013-08-05

Start date

2014-12-09

Completion date

2020-04-06

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to see if the two sterile water injection technique is as effective as the standard four injection technique in relieving lower back pain during labour and birth. If the difference in pain relief between the two techniques, thirty minutes after injection(s) is no greater or less than 1 centimeter on the VAS, the trial will have proven it's hypothesis

Interventions

two intradermal injections of 0.1 ml of sterile water over the posterior superior illiac spines. The injection is administered when the woman describes the backpain during any stage of labour, as being equal to or greater than seven on a Visual analogue Scale (VAS). The two injections are administered during a single contraction, by two midwives.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Women at term (between 37 and 42 weeks) Nulliparous or multiparous Singleton pregnancy Cephalic presentation First stage labour (spontaneous or induced) No previous analgesia Back pain assessed by VAS as greater than or equal to 7 Ability to give informed consent.

Exclusion criteria

Gestation < 37 weeks Multiple pregnancy Malpresentation (Breech Transverse etc.) Second stage labour Pharmacological analgesia less than 4 hours prior to Sterile Water Injections (SWI) Back pain assessed by VAS < 7 Any medical complications of pregnancy or labour ( type 1 diabetes hypertension requiring intrapartum management).

Outcome results