Effect of using metformin versus not using on the incidence of gestational diabetes and preeclampsia in pregnant women with polycystic ovary: A randomized clinical trial
To assess the effect of using metformin versus not using on the incidence of gestational diabetes and preeclampsia in pregnant women with polycystic ovary
Design
This is a randomized clinical trial, phase III, in which 170 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible pregnant women with polycystic ovary who will refer to Fatemieh Hospital of Hamadan City during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Pregnant;
Polycystic Ovary
Exclusion criteria:
A history of repeated abortion;
Uterine abnormality;
A history of chronic diseases such as lupus and renal failure
Intervention groups
Intervention group: Routine care during pregnancy and tablet metformin 1000 to 2000 mg (1 or 2 tablets) daily until the end of pregnancy
Control group: Just routine care during pregnancy
Main outcome variables
Primary outcome:
Assessing gestational diabetes
Assessing the preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N252
Registration date:2018-11-24, 1397/09/03
Registration timing:prospective
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using metformin versus not using on the incidence of gestational diabetes and preeclampsia in pregnant women with polycystic ovary: A randomized clinical trial
Public title
Effect of using metformin on the incidence of gestational diabetes and preeclampsia in pregnant women with polycystic ovary
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Pregnant;
Polycystic ovary
Exclusion criteria:
A history of repeated abortion;
Uterine abnormality;
A history of chronic disease such as lupus and renal failure
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we prepared 4 sheets of paper, writing on 2 sheets intervention and on 2 sheets control. The paper sheets were pooled and randomly drawn 1 at a time for each patient without replacement until all 4 sheets were drawn. The 4 paper sheets were then placed back into the container and this action repeated until the sample size was reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-10-12, 1397/07/20
Ethics committee reference number
IR.UMSHA.REC.1397.473
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy
2
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Assessing the gestational diabetes
Timepoint
Every 3 months until end of pregnancy
Method of measurement
Through laboratory diagnostic test measuring blood glucose
2
Description
Assessing the preeclampsia
Timepoint
Every 2 weeks until end of pregnancy
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during pregnancy and tablet metformin 1000 to 2000 mg (1 or 2 tablets) daily until end of pregnancy
Category
Treatment - Drugs
2
Description
Control group: Just routine care during pregnancy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr. Elham Ghasemi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
eghasemi1395@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Elham Ghasemi
Position
Gynecologic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
eghasemi1395@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Shohreh Alimohamadi
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
dr.alimohamadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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