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Comparison of the effect of transcutaneous electrical nerve stimulation (TENS) with the injection of pethidine and promethazine in labor pain reduction

Protocol summary

Study aim
Comparison of the effect of transcutaneous electrical nerve stimulation (TENS) with the injection of pethidine and promethazine in labor pain reduction
Design
This three-phase clinical trial, with parallel groups, randomized (using the random allocation rule) is performed on 90 pregnant women.
Settings and conduct
This randomized clinical trial study is performed on 90 pregnant women, in Yas Hospital. The sampling method is a convenience method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with 16 to 40 years and term pregnancy (gestational age: 37 to 41 weeks), Singleton pregnancy, Cephalic presentation, Spontaneous vaginal delivery Criteria for not entering: Preeclampsia, Gestational diabetes with insulin therapy, Intrauterine growth restriction, History of C/section, Meconium in amniotic fluid, History of transmural myomectomy or uterus rupture
Intervention groups
In the active phase of labor (cervical dilation: 4 cm with uterine contractions), in the first group of intervention, 100 milligrams of pethidine and 250 micrograms of promethazine will be injected intramuscular, if the pregnant women will not respond to the primary dose, the second dose will be applied. In the second group of intervention, TENS continuously for 120 minutes will be applied.
Main outcome variables
The labor pain will be measured before the intervention and half time after the intervention by Visual Analogue Scale.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190208042655N1
Registration date: 2021-05-11, 1400/02/21
Registration timing: prospective

Last update: 2021-05-11, 1400/02/21
Update count: 0
Registration date
2021-05-11, 1400/02/21
Registrant information
Name
Nafiseh Saedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 0727
Email address
nsaedi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of transcutaneous electrical nerve stimulation (TENS) with the injection of pethidine and promethazine in labor pain reduction
Public title
Comparison of the effect of TENS with the injection of pethidine and promethazine in labor pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 16 to 40 years and term pregnancy (gestational age: 37 to 41 weeks) Singleton pregnancy Cephalic presentation Spontaneous vaginal delivery
Exclusion criteria:
Preeclampsia Gestational diabetes with insulin therapy Intrauterine growth restriction History of C/section Meconium in amniotic fluid History of transmural myomectomy History of uterus rupture
Age
From 16 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 45 letters A and 45 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2019-04-15, 1398/01/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.013

Health conditions studied

1

Description of health condition studied
Painless delivery
ICD-10 code
F45.41
ICD-10 code description
Pain disorder exclusively related to psychological factors

Primary outcomes

1

Description
The labor pain
Timepoint
Before the intervention and half time after the intervention
Method of measurement
By Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the active phase of labor (cervical dilation: 4 cm with uterine contractions), in the first group of intervention, 100 milligrams of pethidine and 250 micrograms of promethazine will be injected intramuscular, if the pregnant women will not respond to the primary dose, the second dose will be applied.
Category
Treatment - Drugs

2

Description
Intervention group: In the active phase of labor (cervical dilation: 4 cm with uterine contractions), TENS continuously for 120 minutes will be applied.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Nafiseh Saedi
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
nsaedi@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Sahraiyan
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Fax
Email
nsaedi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8608 9089
Fax
Email
nsaedi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8608 9089
Fax
Email
nsaedi@sina.tums.ac.ir

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
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Saedi, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Nafiseh Saedi
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Nafiseh Saedi.
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