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Subcutaneous Sterile Water Injection for Relief of Low Back Pain

W

Woman's Health University Hospital, Egypt

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Low Back Pain

Treatments

Other: saline injection
Other: Subcutaneous sterile water injection

Study type

Interventional

Funder types

Other

Identifiers

NCT02813330
Women Health Hospital

Details and patient eligibility

About

To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth

Full description

Study sample:

The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection)

Setting:

Labor ward in Women's health center at Assiut university hospital

Study design:

Experimental Randomized control study

Sample size:

The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria

  • In labour (spontaneous or induced
  • During first stageof labour
  • Primary and multiparous women
  • A term singleton pregnancy (between 37 + 0 and 41 weeks)
  • Have a fetus in a cephalic presentation
  • Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003)
  • Provide informed consent.

Exclusion criteria

  • Multiple pregnancy
  • Malpresentation (breech, transverse, shoulder)
  • Previous CS
  • Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.

Study Tools:

  1. Personal data questionnaire
  2. Visual Analogue Scale and Face analogue scale
  3. Satisfaction scale

Enrollment

336 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • In labour (spontaneous or induced record
  • During first stage of labour
  • Primary and multiparous women
  • A term singleton pregnancy (between 37 + 0 and 41 weeks)
  • Have a fetus in a cephalic presentation
  • Experience back pain assessed by visual analogue scale VAS and Face pain analogue
  • Provide informed consent.

Exclusion criteria

  • Women with chronic disease
  • Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
  • Complicated labor process ( obstructed, preterm labor, twins)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

336 participants in 2 patient groups

Sterile Water injection
Experimental group
Description:
Subcutenous injection at low back portion during labor pain
Treatment:
Other: Subcutaneous sterile water injection
Other: saline injection
saline injection
Experimental group
Description:
Subcutenous injection at low back portion during labor pain
Treatment:
Other: Subcutaneous sterile water injection
Other: saline injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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