A randomised, controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour.

For women in labour with back pain does the single sterile water injection technique compared to the four injection technique provide comparable pain relief

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000964213

Acronym

The SWITCh Trial

Enrollment

320

Registered

2009-11-09

Start date

2010-01-11

Completion date

2011-01-10

Last updated

2021-02-22

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 single 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 centremeter on the VAS, the trial will have proven it's hypothesis

Interventions

Single intradermal injection of 0.1 ml of sterile water to the most painful point, or central to the most painful area of backpain as indicated by the woman. The injection is administered when the woman descibes the backpain during any stage of labour, as being equal to or greater than seven on a Visual analogue Scale (VAS).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

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 prior to Sterile Water Injections (SWI) Back pain assessed by VAS < 7 Any complications of pregnancy or labour (bleeding, diabetes hypertension).

Outcome results