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Completed

NCT Number: NCT02697994

Sterile Water Injections For Pain Relief İn Labor

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.

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Key information

Conditions

Labour Pain Back Pain Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sterile Water

Other

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

Dry Injections

Other

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

Primary outcomes

  1. Pain scores-30

    Time frame: at 30 mins after interventions

    In pain scoring Visual Analog Scale was used

Secondary outcomes

  1. Pain scores-10

    Time frame: at 10 mins after interventions

    In pain scoring Visual Analog Scale was used

  2. Pain scores-60

    Time frame: at 60 mins after interventions

    In pain scoring Visual Analog Scale was used

  3. Pain scores-90

    Time frame: at 90 mins after interventions

    In pain scoring Visual Analog Scale was used

  4. Pain scores-120

    Time frame: at 120 mins after interventions

    In pain scoring Visual Analog Scale was used

  5. Pain scores-180

    Time frame: at 180 mins after interventions

    In pain scoring Visual Analog Scale was used

  6. APGAR score of neonate

    Time frame: at 5 mins after birth

  7. Maternal satisfaction

    Time frame: at 1 hour after birth

    Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others

  8. Rates of breastfeeding-1

    Time frame: at 1 hour after birth

    In breastfeed scoring The Infant Breastfeeding Assessment Tool was used

  9. Rates of breastfeeding-24

    Time frame: at 24.hours after birth

    In breastfeed scoring The Infant Breastfeeding Assessment Tool was used

Sponsors and collaborators

Lead sponsor

University of Beykent

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2016
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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