Determining of the effect of promethazine and magnesium sulfate on labor pain intensity and progress
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 90 patients.
Settings and conduct
This study is a double-blinded clinical trial that will be conducted in Motazedi Hospital affiliated to Kermanshah University of Medical Science. Patients are also coded according to the blocking method. The clinical supervisor and statistical consultant will not be aware of the groups.
Participants/Inclusion and exclusion criteria
Being primiparous; the beginning of the active phase (3-4 cm dilatation) and no rupture of membrane.
Intervention groups
Intervention group 1: for women in this group, 25 mg promethazine ampoule will be injected intramuscularly. Intervention group 2: for women in this group, 10 cc of 50% magnesium sulfate will be poured on their cervix. Control group: for this group, no intervention will be implemented and they will receive routine care.
Main outcome variables
Labor pain severity; labor progression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027633N10
Registration date:2024-06-01, 1403/03/12
Registration timing:registered_while_recruiting
Last update:2024-06-01, 1403/03/12
Update count:0
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Foruzan Sharifipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
f.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-09-19, 1403/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of promethazine and topical magnesium sulfate on labor pain severity and progression in primiparous women
Public title
Comparison of the effect of promethazine and topical magnesium sulfate on labor pain severity and progression in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age between 18 and 35 years
Full-term pregnancy
Primiparous
Single and live fetus with cephalic presentation
Estimated fetal weight between 2500 and 4000 grams
Low-risk pregnancy
No use of narcotic drugs and painkillers during In the past 48 hours
The absence of chronic and systemic diseases such as diabetes, hypertension, heart disease, epilepsy
The beginning of the active phase (3-4 cm cervical dilatation)
No rupture of membrane
Exclusion criteria:
Withdrawal of participants during the study
The occurrence of any obstetric emergencies
Contraindications of normal delivery such as: fetal distress, placental abruption, severe vaginal bleeding, umbilical cord prolapse, etc.
The occurrence of emergency cesarean section before the completion of the study
Non-cooperation of participants
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The mothers will be randomly assigned in to 3 groups in order to Block random allocation method with block size of 6, and ratio of 1:1:1. It works by randomizing participants within blocks such that an equal number are assigned to each treatment. This will be done with Epi Info™6.0 software.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the purpose of blinding, the use of drugs in the two intervention groups will be done by the researcher and all other examinations and measures will be performed by the research associate who will not be aware of the groups and will be recorded in the partograph form. Also, the method of blinding the data analyzer will be used. Therefore, the study will be double -blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-04-22, 1403/02/03
Ethics committee reference number
IR.KUMS.REC.1403.050
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Labor pain severity
Timepoint
Before the intervention, two and four hours after the intervention
Method of measurement
Pain visual analog scale
2
Description
Delivery progression
Timepoint
Before the intervention, two and four hours after the intervention
Method of measurement
Partograph form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (promethazine ): at the beginning of the active phase, women in the promethazine group, in addition to receiving routine care, will be injected intramuscularly with 25 mg of promethazine ampoules.
Category
Treatment - Drugs
2
Description
Intervention group (magnesium sulfate): at the beginning of the active phase, women in the magnesium sulfate group, in addition to receiving routine care, on the women's cervix, 10 cc of 50% magnesium sulfate will be instilled.
Category
Treatment - Drugs
3
Description
Control group: for this group no intervention will perform and they will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazadi Hospital
Full name of responsible person
Foruzan Sharifipour
Street address
Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
6718814474
Phone
+98 83 3724 6351
Email
sharifipour_fr91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sirus Jalili
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Foruzan Sharifipour
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isar Square, Daulat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
009838162538
Email
sharifipour_fr91@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Foruzan Sharifipour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isar Square, Daulat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
+98 83 3816 2538
Email
sharifipour_fr91@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Foruzan Sharifipour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Isar Square, Daulat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719816593
Phone
+98 83 3816 2538
Email
sharifipour_fr91@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available