Evaluation of the therapeutic effect of metformin in the prevention of preeclampsia
Design
Clinical randomized triple-blind, phase 3, 52 pregnant women with non-severe preeclampsia who presented for pregnancy care randomly (by lottery method) divided into two groups: metformin and placebo
Settings and conduct
Shahid Akbarabadi hospital and Firouzabadi hospital
Participants/Inclusion and exclusion criteria
inclusion criteria: Single pregnancies.
Exclusion criteria: eclampsia, severe preeclampsia, kidney failure, insulin-treated diabetics, indications for termination of pregnancy other than hypertension, multiple pregnancies.
Intervention groups
Patients are divided two groups, metformin, 1000 mg per day in intervention group and placebo in control group and then people are followed until the end of pregnancy.
Main outcome variables
Incidence of severe preeclampsia and its maternal and fetal complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210316050725N1
Registration date:2021-05-28, 1400/03/07
Registration timing:prospective
Last update:2021-05-28, 1400/03/07
Update count:0
Registration date
2021-05-28, 1400/03/07
Registrant information
Name
shahnaz Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 3244
Email address
ahmadishahnaz2005@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of metformin in prevention from severe preeclampsia
Public title
The effect of the metformin in preventing of the preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non severe preeclampsia
Single pregnancy
Exclusion criteria:
Eclamsia
Severe reeclamsia
Renal failure
Insulin -treated diabet
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the total volume of the sample.papers A and B are placed in the lottery container. Then the papers are randomly removed from the container without replacement and the created sequence is recorded.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The person receiving the medication, the person giving the medication, and the person analyzing the results are unaware of the type of medication
(metformin or placebo) used.
Placebo (paper A) and metformin tablets (paper B) are poured in equal numbers in a bag. and at the time of the patient's visit who are eligible for the study, she is said to have picked up one of the papers. pills then given to the patient based on the patient's choice (blind) . (the resident who gives the pill does not know which group of placebo and which group is metformin due to the same packaging. she is blind .). The analyzer also reports the final results under groups A and B (without knowing the type of group).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical science
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
1168743514
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.IUMS.FMD.REC.1398.472
Health conditions studied
1
Description of health condition studied
Non severe preeclampsia
ICD-10 code
O14.00
ICD-10 code description
Mild to moderate pre-eclampsia, unspecified trimester
Assesment of Fast blood sugar and 2 hours after meal
7
Description
Fetal health assessment tests
Timepoint
Weekly
Method of measurement
Non stress test and biophysical profile
8
Description
Proteinurea
Timepoint
Weekly
Method of measurement
By collecting urine 24 hours a day
Intervention groups
1
Description
In the intervention group, pregnant woman with only high blood pressure is given 1000 mg of metformin during her entire pregnancy, and during the course of labor, the symptoms of severe preeclampsia and fetal growth are evaluated
Category
Treatment - Drugs
2
Description
In the control group, pregnant woman with only high blood pressure is given a placebo for the entire pregnancy and the symptoms of severe preeclampsia and fetal growth are assessed during labor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi hospital and Firouzabadi hospital
Full name of responsible person
Shahnaz Ahmadi
Street address
Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
ahmadishahnaz2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahnaz Ahmadi
Street address
Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
Ahmadishahnaz2005@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shahnaz Ahmadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
Ahamdishahnaz2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahnaz Ahmadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
Ahmadishahnaz2005@yahoocom
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahnaz Ahmadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 3244
Email
ahmadishahnaz2005@yahoocom
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
paper
When the data will become available and for how long
one months after paper print
To whom data/document is available
all people
Under which criteria data/document could be used
Email
From where data/document is obtainable
Demandants can contact by Dr. Shahnaz Ahmadi, the principal investigator, or the education office of Akbrabadi Hospital via the email ahmadishahnaz2005 @ yahoo.com and call 02155633244
What processes are involved for a request to access data/document