Comparison of effects of acetaminophen and diclofenac received as a painkiller on the results of medical abortion with misoprostol
Design
A clinical trial containing control group, with parallel groups, without blinding, randomized, phase 3 per 100 patients. Excel software rand function has been used for randomization.
Settings and conduct
First, consent will be received from the patients admitted to the hospital and the necessary explanations will be given to them. Then, at the time of the first usage of misoprostol, 500 mg of acetaminophen tablets for group 1 patients and 75 mg diclofenac tablets for group 2 patients will bi given. Repeated doses of analgesia are given at 6 hours and 12 hours and then at 12-hour intervals for groups 1 and 2. Repeated doses are the same as the first dose. Body temperature, pulse, blood pressure and other symptoms are monitored every hour. Women are hospitalized and examined for 4 hours after abortion and before discharge. The VAS scale is used to measure the amount of pain and results will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All women candidates for abortion in the first trimester and the second trimester of pregnancy without risk factors.
exclusion criteria: All women candidates for abortion in the first trimester and the second trimester of pregnancy with risk factors.
Intervention groups
Study Members are divided into two groups: 1_acetaminophen, 2_diclofenac. In the first group, acetaminophen tablets are given to each member and diclofenac tablets are given to each member in the second group.
Main outcome variables
Comparison of the effect of acetaminophen and diclofenac on pain relief in women
Which of the two drugs acetaminophen and diclofenac is more effective in controlling the patient's pain?
Which of the two drugs has the least interaction with misoprostol?
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220411054506N1
Registration date:2022-06-15, 1401/03/25
Registration timing:prospective
Last update:2022-06-15, 1401/03/25
Update count:0
Registration date
2022-06-15, 1401/03/25
Registrant information
Name
Siavash Taherikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 082 0810
Email address
mail4siavash@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of acetaminophen and diclofenac received as a painkiller on the results of medical abortion with misoprostol in pregnant women
Public title
Comparison of effects of acetaminophen and diclofenac received as a painkiller on the results of medical abortion with misoprostol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the pregnant women in first trimester and second trimester (confirmed by sonography) candidates to abortion.
Samples will be taken by simple random sampling. Then each member of the sample will be randomly assigned to one of the two subgroups:1- acetaminophen 2- diclofenac with computer software.
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 Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences, Pajuhesh Boulevard, Banganjab
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2022-05-22, 1401/03/01
Ethics committee reference number
IR.MEDILAM.REC.1401.009
Health conditions studied
1
Description of health condition studied
Medical Abortion
ICD-10 code
O02.1
ICD-10 code description
Missed abortion
Primary outcomes
1
Description
The effect of acetaminophen and diclofenac on the outcome and success of misoprostol abortion
Timepoint
The beginning and end of the medical abortion process
Method of measurement
View the abortion result at the end of the process
Secondary outcomes
1
Description
Comparison of the effects of acetaminophen and diclofenac on pain relief
Timepoint
At the beginning of the abortion process and four hours apart until the end of the abortion
Method of measurement
According to the numerical scale of pain rating
Intervention groups
1
Description
Acetaminophen group: 500 mg acetaminophen tablets are prescribed for patients in this group. Repeated doses of analgesia are given at 6 hours and 12 hours and then at 12-hour intervals. Repeated doses are the same as the first dose.
Category
Treatment - Drugs
2
Description
Diclofenac group: Diclofenac 75 mg tablets are prescribed for patients in this group. Repeated doses of analgesia are given at 6 hours and 12 hours and then at 12-hour intervals. Repeated doses are the same as the first dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ilam Taleghani Hospital
Full name of responsible person
ِDr Elham Pournajaf
Street address
NO 1, Khabarnegar Ave, Shahid Beheshti Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 44 2227 1430
Email
ilamtaleghanihospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Abbas Maleki
Street address
Deputy of Research and Technology, Ilam University of Medical Sciences, Pajuhesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
5
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
Ilam University of Medical Sciences
Full name of responsible person
Siavash Taherikia
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ilam University of Medical Sciences, Pajuhesh Boulevard, Banganjab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
mail4siavash@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Siavash Taherikia
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
NO 213, Boostan 2, Ilam University of Medical Sciences, Pajuhesh Boulevard, Banganjab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
mail4siavash@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Siavash Taherikia
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ilam University of Medical Sciences, Pajuhesh Boulevard, Banganjab
City
ایلام
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
mail4siavash@gmail.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