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Sterile Water Injections For Pain Relief İn Labor

Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02697994
Enrollment
168
Registered
2016-03-03
Start date
2013-06-30
Completion date
2014-03-31
Last updated
2016-03-03

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

Conditions

Back Pain, Labour Pain

Keywords

Sterile Water Injection, Midwifery

Brief summary

ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases. Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.

Interventions

OTHERSterile Water

0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.

OTHERDry Injections

dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.

Sponsors

University of Beykent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Aged between 18-35 * 37-42 weeks of gestation * Expecting vaginal delivery * Cephalic presentation * Single, healthy fetus * Spontaneous onset of labor * Active phase of first stage of labor (3-7 cm cervical dilatation) * Severe low back pain (VAS\>7cm) * Required pain relief

Exclusion criteria

* Gestation \<37 weeks * Multiple pregnancy * Malpresentation * Second stage labour * Pharmacological analgesia prior to SWI * Back pain assessed by VAS \<7 * Women whose labour would be considered high risk

Design outcomes

Primary

MeasureTime frameDescription
Pain scores-30at 30 mins after interventionsIn pain scoring Visual Analog Scale was used

Secondary

MeasureTime frameDescription
Pain scores-60at 60 mins after interventionsIn pain scoring Visual Analog Scale was used
Pain scores-90at 90 mins after interventionsIn pain scoring Visual Analog Scale was used
Pain scores-120at 120 mins after interventionsIn pain scoring Visual Analog Scale was used
Pain scores-180at 180 mins after interventionsIn pain scoring Visual Analog Scale was used
Pain scores-10at 10 mins after interventionsIn pain scoring Visual Analog Scale was used
Maternal satisfactionat 1 hour after birthLikelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others
Rates of breastfeeding-1at 1 hour after birthIn breastfeed scoring The Infant Breastfeeding Assessment Tool was used
Rates of breastfeeding-24at 24.hours after birthIn breastfeed scoring The Infant Breastfeeding Assessment Tool was used
APGAR score of neonateat 5 mins after birth

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026