Assessing the efficacy of the prophylactic metformin administration in the prevention of gestational diabetes mellitus in non-diabetic obese pregnant women referred to Motahari Teaching Hospital
Main goal: Assessing the efficacy of prophylactic metformin administration in the prevention of gestational diabetes mellitus in non-diabetic obese pregnant women referred to Mottahari Hospital (Urmia)
Specific goals: Comparing the requirement of insulin administration between groups
Comparing the final insulin dosage between groups
Comparing the incidence of polyhydramnios between groups
Comparing the incidence of preterm labor between groups
Comparing the cesarean section between groups
Comparison of infant hospitalization in the intensive care unit between groups
Design
This clinical trial aims to enroll 342 eligible patients. Block randomization will be performed to stratify patients into the control and intervention groups. The main group will receive metformin, while the controls will be exempt from receiving metfromin or placebo.
Settings and conduct
After enrolling eligible patients, metformin administration will commence as explained. A two-hour glucose tolerance test (75gr) will be performed between weeks 24 and 28 of pregnancy. Positive patients will be referred to a perinatologist and treated if necessary. Screening for polyhydramnios will be performed throughout the third trimester. The following factors will be taken into consideration at the time of delivery:
final insulin dosage, method of delivery, indications of cesarean section, gestational age and hospitalization at the intensive care unit
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age >16 years
Gestational age >3 months
Singleton pregnancy
Exclusion criterias:
Fetal anomalies
Multifetal pregnancy
History of overt diabetes mellitus
Intervention groups
The intervention group will receive metformin (500 mg every 12 hours; oral), starting from the 12th week of pregnancy until delivery
Main outcome variables
Frequency of GDM
Required insulin dosage in GDM patients
Frequency of polyhydramnios
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200113046112N1
Registration date:2020-03-17, 1398/12/27
Registration timing:registered_while_recruiting
Last update:2020-03-17, 1398/12/27
Update count:0
Registration date
2020-03-17, 1398/12/27
Registrant information
Name
Shiva Ghayor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 3629
Email address
broumand.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-18, 1398/10/28
Expected recruitment end date
2020-07-18, 1399/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the efficacy of the prophylactic metformin administration in the prevention of gestational diabetes mellitus in non-diabetic obese pregnant women referred to Motahari Teaching Hospital
Public title
Prophylactic properties of metformin in the prevention of gestational diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age >16 years
Gestational age <3 months
Singleton pregnancy
Body mass index ≥30
Exclusion criteria:
Multifetal pregnancy
Fetal anomaly
Previous history of diabetes mellitus, gestational diabetes mellitus, impaired fasting glucose or impaired glucose tolerance test
History of corticosteroid use
Heavy alcoholism
History of adverse or allergic reactions to metformin
History of underlying medical conditions (e.g. hypertension, renal failure, liver disease, malabsorption)
Age
From 16 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
342
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be performed to stratify patients into two groups: intervention and control. Each block will include 6 patients. All possible combinations of AAABBB will be listed and coded individually. Considering a study population of 342 patients, randomization of patients into 57 blocks is required. Blocks will be assigned to either groups in an alternating order.
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 Urmia University of Medical Sciences
Street address
orjhans Ave., Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
57147833
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.UMSU.REC.1398.388
Health conditions studied
1
Description of health condition studied
Gestational Diabetes Mellitus in obese pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of gestational diabetes mellitus
Timepoint
Between weeks 24 and 28 of pregnancy
Method of measurement
Through the performance of two-hour glucose tolerance test with 75 grams of glucose
Secondary outcomes
1
Description
Requirement of insulin administration in the setting of gestational diabetes mellitus
Timepoint
Since the 24th week of pregnancy until time of delivery
Method of measurement
Questionnaire
2
Description
Final dosage of administered insulin at the time of delivery
Timepoint
One day prior to delivery
Method of measurement
Patient documentations
3
Description
the incidence of polyhydramnios
Timepoint
Final pregnancy trimester
Method of measurement
Ultrasound imaging
4
Description
Incidence of preterm labor
Timepoint
At the time of delivery
Method of measurement
Assessment of gestational age will be performed based on ultrasound imaging and previously documented data pertaining to the current pregnancy
5
Description
Frequency of performed Cesarean Sections
Timepoint
At the time of delivery
Method of measurement
Hospitalization documents or by researcher designed questionnaire
6
Description
Frequency of hospitalization at the neonatal intensive care unit
Timepoint
At the time of birth
Method of measurement
Researcher designed questionnaire or hospitalization documentations
Intervention groups
1
Description
Administration of metformin(as F.C.Tablets metformin hydrochloride, manufactored in Iran, Kharazmi/ 500 mg every 12 hours; oral) starting from the 12th week of pregnancy until the time of delivery
Category
Prevention
2
Description
Control group: They will not be prescribed medication and will undergo routine pregnancy care and follow-up.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Farzaneh Broumand
Street address
Orjans Ave., Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
51147
Phone
+98 44 3223 7078
Email
sh.ghayor90@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Iraj Mohebbi
Street address
Orjans Ave., Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3293 7271
Email
sh.ghayor90@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shiva Ghayor
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Ave., Motahari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
+98 44 3223 7078
Email
sh.ghayor90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shiva Ghayor
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Ave., Motahari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
+98 44 3223 7078
Email
sh.ghayor90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shiva ghayor
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Ave., Motahari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
+98 44 3223 7078
Email
sh.ghayor90@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