Determining the effect of oral Ibuprofen on reducing pain in medical abortions in the first trimester of pregnancy
Design
This single-blind, randomized clinical trial will be performed on 25 abortion candidates and patients will be given 400 mg of Ibuprofen lysine orally and their pain will be assessed.
Settings and conduct
This single-blind, randomized clinical trial will be performed on 25 abortion patients in a teaching hospital in Zanjan, and patients will be given 400 mg of ibuprofen lysine orally and their pain will be assessed. Patients are randomly divided into two groups by block randomization method. In this study, participants, data collectors and those who evaluate the outcome will be completely unaware of the medication prescribing protocol.
Participants/Inclusion and exclusion criteria
Women who are candidates for medical abortion in the first trimester between the ages of 18 and 40 will be enrolled the study. People with a history of gastrointestinal, kidney and coagulation problems will be excluded from the study.
Intervention groups
Patients will receive 400 mg Ibuprofen lysine orally at the same time as the first dose of misoprostol and, if necessary, this dose will be repeated every 4 hours.
Main outcome variables
Pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220409054465N1
Registration date:2022-05-16, 1401/02/26
Registration timing:registered_while_recruiting
Last update:2022-05-16, 1401/02/26
Update count:0
Registration date
2022-05-16, 1401/02/26
Registrant information
Name
Lida Grrosi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 3164
Email address
lgarrosi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-07-25, 1401/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral NSAID (Ibuprophen) as pain relief in first trimester medical abortion in patients referring to Ayatollah Mousavi hospital
Public title
Pain relief in first trimester medical abortions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with indication for medical abortion in the first trimester
In this study, we will use the block randomization method. The size of all blocks would be four and equal. Random allocation software is also used to generate a random sequence of blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participant, data collectors and outcome assessors, will be completely unaware of the drug prescribing protocol.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1435689752
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.ZUMS.REC.1397.269
Health conditions studied
1
Description of health condition studied
Medical Abortion
ICD-10 code
004
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
Pain score
Timepoint
Every one hour until 6 hours after defecation of pregnancy products
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral administration of 400 mg ibuprofen (single dose) from Aramis farmed factory
Category
Treatment - Drugs
2
Description
control group: single dose of oral placebo (Tablets containing starch which will be similar to ibuprofen )
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Lida Garrosi
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Lgarrosi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
Zanjan University of Medical Sciences Campus, Dr. Yousef Sabouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Lida Garrosi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gynecology Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678552
Phone
+98 21 8806 4148
Email
Lgarrosi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Lida Garrosi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gynecology Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678552
Phone
+98 21 8806 4148
Email
Lgarrosi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Lida Garrosi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gynecology Clinic of Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678552
Phone
+98 21 8806 4148
Email
Lgarrosi@zums.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
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data including the main and secondary outcomes can be shared.
When the data will become available and for how long
Access period starts from 2023
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals.
From where data/document is obtainable
Contact the research expert of the Infertility Clinic of Zanjan University to receive the required documents or data.
What processes are involved for a request to access data/document
To submit a request, it is enough to contact the mentioned expert and send a written and signed request to her.