Comparison between the analgesic effect of subdermal and intradermal injection of sterile water on labor pain
Design
randomized Clinical trial with 2 intervention and 1 placebo group
parallel and double blind
Settings and conduct
The samples are pregnant, nulliparous, ≥37 weeks gestation women, 15-40 years old that will come to labor room of Akbarabadi Hospital. The women that have ≥4 cm dilatation and will sign the inform consent will enter the research. In first group gynecologic resident will inject 0.1 cc sterile water on sacral region intradermally ( on posterior superior iliac spine of each side ) and another 0.1 cc two cm upper and outer. In second group the same amount of sterile water will be injected on the same sites and in third group we will only contact the needle with the same sites of sacral skin. The sample size in each group is 40.
The gynecologic resident will do the injections in LDR and only she will know the rout of injection.
The midwife of labor room will do the VAS test before intervention and 10, 30, 40, 90 and 120 minutes after intervention.
The data will be analyzed by SPSS 22 by using T test and chi- square test and for finding the correlation pearson,correlation coefficient.
Participants/Inclusion and exclusion criteria
include criteria:
1- Nulliparity
2-dilatation 4 cm or more
3. Cephalic
4- 37 weeks or more
exclude criteria:
1. not filled inform consent
2. multi parity
3. history of lower abdominal or back pain before pregnancy
4. fetal demise
5. lesion or infection of injection site
6. coagulation disorders
Intervention groups
In first group 0.5 cc sterile water will be injected intradermal and in second group, subdermal. In third group we will have only contact of needle with skin
Main outcome variables
Comparison of severity of labor pain in 3 groups
General information
Reason for update
Acronym
The effect of sterile water injection on active labor pain
IRCT registration information
IRCT registration number:IRCT20170924036365N2
Registration date:2019-03-18, 1397/12/27
Registration timing:retrospective
Last update:2019-03-18, 1397/12/27
Update count:0
Registration date
2019-03-18, 1397/12/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
almassi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-16, 1397/09/25
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
2018-07-10, 1397/04/19
Actual recruitment end date
2018-11-09, 1397/08/18
Trial completion date
2018-11-09, 1397/08/18
Scientific title
Comparison between analgesic effect of intra dermal and sub dermal injection of sterile water on active labor pain
Public title
effect of intra dermal and sub dermal injection of sterile water on active labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
first pregnancy(nulliparyte)
dilatation of cervix 4cm or more
cephalic baby
gestational age 37w or more and planned for vaginal delivery
Exclusion criteria:
No inform consent
Multi parity
History of low back pain or abdominal pain unrelated to delivery
fetal demise
Skin lesion or infection on injection site
coagulation disorders of mother
Age
From 15 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
1-Randomization will be done by using random allocation table.
The gynecologic resident will do all of the injections
Blinding (investigator's opinion)
Double blinded
Blinding description
The midwife of labor will do all of the VAS tests.
The gynecologic resident of this research will do all of the injections in LDR. The midwife of labor dose not know that witch method is done for each mother.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University medical sciences ethic committee, Hemmat high way, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.IUMS.FMD.REC.1397.012
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
047.1
ICD-10 code description
047.1
Primary outcomes
1
Description
Severity of pain
Timepoint
before intervention and 10,30,60,90, and 120 minute after intervention
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group- To 40 patient, 0.5 cc sterile water will be injected subdermal with the insulin needle in the four sacral area (two injections in the posterior superior iliac spine and two other injections of one centimeter outer and two centimeters upper than the first place)
Category
Treatment - Other
2
Description
Second intervention group- in 40 women, 0.5 cc sterile water will be injected intradermal with the insulin needle in the four sacral area (two injections in the posterior superior iliac spine and two other injections of two centimeter outer and two centimeters upper than the first place)
Category
Treatment - Other
3
Description
Control group- Just touch the tip of the needle with the skin of sacral area
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi hospital
Full name of responsible person
Fariba Almassi
Street address
Iran University of medical sciences, Hemmat high way, Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 6650 9283
Email
almassi.f@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Almassinokiani
Street address
Hemmat high way
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9283
Email
almassi.f@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Almassi
Position
Professor in obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Iran University of medical sciences, Hemmat high way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
almassi.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Almassi
Position
Professor in obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hemmat high way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
almassi.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nassim Ahani
Position
Resident of gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hemmat high way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
nassim.ahani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
By publishing article resulted from this research
When the data will become available and for how long
One year later
To whom data/document is available
All of the people that read the article
Under which criteria data/document could be used
Only Dr Fariba Almassi
From where data/document is obtainable
1-By reading the article
2-By contact with Dr Fariba Almassi
What processes are involved for a request to access data/document
Until 1 year after publication, during 6 months after contact the data will be emailed