Investigating the effectiveness of metformin in preventing preeclampsia in pregnant women
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 2 on 160 patients. A table of random numbers was used for randomization.
Settings and conduct
This study will be conducted on pregnant mothers aged 18 to 45 who have a risk factor for preeclampsia in 1402 at Isfahan University of Medical Sciences. Blinding was not achieved in this study.
Participants/Inclusion and exclusion criteria
This study will be conducted in Isfahan University of Medical Sciences in 1402 on pregnant mothers who have a risk factor for preeclampsia and do not have any other underlying disease.
Intervention groups
People in the intervention group in this study are treated with metformin 500 daily from the 12th week of pregnancy. The control group does not receive drugs
Main outcome variables
preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230730058975N1
Registration date:2023-08-12, 1402/05/21
Registration timing:prospective
Last update:2023-08-12, 1402/05/21
Update count:0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
vida Behzad Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 511 0976
Email address
behzadfar_neda@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of metformin in the prevention of preeclampsia in pregnant women at high risk of preeclampsia
Public title
Metformin in the prevention of preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 to 45
informed consent
having risk factors for preeclampsia
Exclusion criteria:
underlying disease like diabetes
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done individually and simply. At first, according to the number of samples, random numbers are created with the help of a random number table and placed in each envelope. The envelopes are also numbered in order. According to the order of people entering the study, an envelope is opened and a random number is determined. If the random number is odd, they are placed in the first group and if it is even, they are placed in the second group.
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 ّIsfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-09-07, 1401/06/16
Ethics committee reference number
IR.MUI.MED.REC.1401.223
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
preeclampsia
Timepoint
Every two weeks from the 12th week of pregnancy
Method of measurement
history taking and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Metformin 500 mg tablets, produced by Iran Najo company, one daily from the 12th week of pregnancy
Category
Treatment - Drugs
2
Description
Control group: No action or medicine
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Vida Behzadfar
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8975673461
Phone
+98 31 3668 0048
Email
behzadfar_neda@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholmreza Asgari
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8975673461
Phone
+98 31 3668 0048
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
vida Behzadfar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8975673461
Phone
+98 913 511 0976
Email
behzadfar_neda@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vida Behzdfar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8975673461
Phone
+98 913 511 0976
Email
behzadfar_neda@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vida Behzadfar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8975673461
Phone
+98 913 511 0976
Email
behzadfar_neda@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD