Determination of the effect of subcutaneous sterile water injection on reducing back pain of women in active phase of labor
Design
This is a randomized single blind clinical trial.
We will have three groups, intervention, control and sham groups. First, the order of these three groups is determined by lottery. From the day of the start of the sampling, the women who will refer to the hospital on the first day will be in the first group. Women in the second day will be in the second group and women on the third day will be in the third group.
Settings and conduct
This study was performed on 90 patients in Afzalipour Kerman hospital in three groups of 30 patients. Intervention group (Injection of 0.5 ml sterile water subcutaneously in 4 site of sacrum), Control group (insertion of needle Without injection of certain material in 4 site of sacrum), Sham group (without needle and injection).
The study is done single blind. Women will not be aware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-35 years, Term pregnancy (38-42 weeks), Singleton live fetus with an approximate weight of more than 2500 grams
Exclusion criteria: No informed consist, Any systemic illness
Intervention groups
The intervention group: Injection of 0.5 ml of sterile distilled water subcutaneously into 4 site of sacrum
Control group : Insertion of needles without injection of specific material in 4 site of sacrum
Sham group: without needle insertion and injection
Main outcome variables
The main outcome of this study is the amount of women's lumbar pain that is expected to be reduced by distilled water. injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181023041427N1
Registration date:2018-12-19, 1397/09/28
Registration timing:retrospective
Last update:2018-12-19, 1397/09/28
Update count:0
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
Farzaneh Khajehnazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4220 8281
Email address
f.khajehnazari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-08-22, 1397/05/31
Trial completion date
2018-09-22, 1397/06/31
Scientific title
Survey of Back Pain Reduction With and Without Subcutaneous Sterile Water Injection In Women With Active Phase of Labor
Public title
Effect of subcutaneous sterile water injection on back pain of Women with Active Phase of Labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous women with an Iranian nationality
Women 18-35 years old
Term pregnancy (38-42 weeks)
Start of uterine contractions and active phase of labor
pain in the lower back
ُSingleton live fetus with a weight of over 2500 grams
The embryo with anterior occiputa position
the absence of sedative drugs, systemic and topical analgesic drugs use up to ninety minutes after intervention
Exclusion criteria:
No Informed consent
Any systemic disease associated with pregnancy including diabetes, hypertension, heart diseases, etc.,
History of narcotic and alcohol consumption, history of psychiatric illness and depression
Trauma created during childbirth (when using labor tools such as forceps or vacuum, a large perineal rupture, postpartum hemorrhage, etc.)
Any need for emergency intervention for maternal and fetal reasons such as placenta abruption
Maternal hospitalization during pregnancy
Emergency cesarean delivery for any reason during labor