Sterile Water Injections For Pain Relief İn Labor

U

University of Beykent

Status

Completed

Conditions

Back Pain
Labour Pain

Treatments

Other: Sterile Water
Other: Dry Injections

Study type

Interventional

Funder types

Other

Identifiers

NCT02697994
SWI1315

Details and patient eligibility

About

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.

Enrollment

168 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

168 participants in 2 patient groups, including a placebo group

Sterile Water Injection
Experimental group
Description:
Participants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area.
Treatment:
Other: Sterile Water
Dry Injection
Placebo Comparator group
Description:
Participants in the control group received 4 dry injections in the same region using an insulin needle .
Treatment:
Other: Dry Injections

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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