Overview

This trial is active, not recruiting.

Condition low back pain
Treatments subcutaneous sterile water injection, saline injection
Phase phase 1/phase 2
Sponsor Woman's Health University Hospital, Egypt
Start date February 2015
End date June 2016
Trial size 336 participants
Trial identifier NCT02813330, Women Health Hospital

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Experimental)
Subcutenous injection at low back portion during labor pain
subcutaneous sterile water injection sterile water injection
sterile water injection in two points of low back pain
saline injection Natural pain relief
Saline injection in two points of low back pain
(Experimental)
Subcutenous injection at low back portion during labor pain
subcutaneous sterile water injection sterile water injection
sterile water injection in two points of low back pain
saline injection Natural pain relief
Saline injection in two points of low back pain

Primary Outcomes

Measure
Pain relief
time frame: two hours for each client
Women's Saisfaction
time frame: each 15 min until 120 min

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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)

Additional Information

Official title Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Woman's Health University Hospital, Egypt.