Main goal: Evaluating the effect of Metformin administration on pregnancy outcomes in healthy overweight pregnant women
specific goals:
1. comparing the frequency of GDM between the main and control groups
2.comparing the frequency of fetal macrosomia between the main and control groups
3. comparing the frequency of preeclampsia between the main and control groups
4.comparing the frequency of abnormal gestational weight gain between the main and control groups
5.comparing the frequency of neonatal hypoglycemia between the main and control groups
6.comparing the frequency of neonatal mortality between the main and control groups
Design
This double blinded RCT will enroll subjects and controls (n:170; 170), administrating metformin (1gr/day) and placebo, until delivery.
Settings and conduct
The main and control (n:170; 170) group will receive metformin (1gr/day) and placebo, respectively, until delivery. At GA: 24-28w, patients will undergo an oral glucose (75gr) challenge test. Estimated birth weight and growth percentile will be assessed twice (GA:32-34 & 37w). Gestational weight gain and the incidence of preeclampsia, fetal hypoglycemia, fetal death and birth defects will also be recorded.
Participants/Inclusion and exclusion criteria
All regnant mothers (GA:12-16 weeks; Singleton; 25<=BMI<30) visitng perinatology clinics of Motahari Hospital will be invited to participate. Those with a history of any general medical condition (e.g. DM, Hepatic disorderrs, hypertension) will be excluded.
Intervention groups
The main and control (n:170; 170) group will receive metformin (1gr/day) and placebo, respectively.
Main outcome variables
Incidence of fetal macrosomia
Incidence of Gestational diabetes mellitus
Incidence of preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190716044229N1
Registration date:2020-02-06, 1398/11/17
Registration timing:registered_while_recruiting
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Samira Esmaili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3367 9124
Email address
samiraesmaili2019@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Metformin administration on pregnancy outcomes in healthy overweight pregnant women
Public title
Impact of metformin on pregnancy outcomes in overweight women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Maternal age >=16 years
Singelton pregnancy
Body mass index: 25<=BMI<30
Negative history of Diabetes Mellitus
Negative history of previous medical conditions
Gestational age between 12 & 16 weeks
Exclusion criteria:
Multiple gestation
Positive history of general medical conditions (e.g. diabetes)
BMI<25 or >=30
Age
From 16 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
350
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be performed by an epidemiologist, via employing specialized software. Blocks A and B, each, shall only include patients form the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
At the start of the study, each patient will be assigned an individual code, which will be used for identification thereafter. These codes will be also be used for randomization and shall only be available and accessible to the individual in charge of coding and grouping the subjects. Intervention and control groups will remain unrevealed to both physician and patient until the conclusion of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
57147833
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.UMSU.REC.1398.143
Health conditions studied
1
Description of health condition studied
Pregnancy outcomes in overweight pregnancies
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Frequency of fetal macrosomia
Timepoint
Post-partum
Method of measurement
Neonatal weighing scale
2
Description
Incidence of gestational diabetes mellitus
Timepoint
From gestational age 24 weeks onward
Method of measurement
Three hour glucose tolerance test
3
Description
Incidence of preeclampsia
Timepoint
Fromgestational age 20 weeks onward
Method of measurement
Measurement of blood pressure and relevant laboratory analyses
4
Description
Gestational weight gain monitoring
Timepoint
From baseline until delivery
Method of measurement
Weighing scale
Secondary outcomes
empty
Intervention groups
1
Description
Intevention group:oral metformin500 mgr/twice a day,( manufactured in Iran) from 12-16week until delivery
Category
Prevention
2
Description
Control group:placebo with chemical composition:(Starch200mg/Cellulose acetate 150 mg/Hypermellose50mg/Sodium lauryl sulfate50mg/Manesium stearate50mg).Round and white in Metformin size.construction of Urmia School of Pharmacy.Laboratory of Pharmaceuticals.twice a dayfrom 12-16 week until delivery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari hospital
Full name of responsible person
Shabnam vazifekhah
Street address
Kosar center (Department of obstetrics and perinatolgy), Motahari Hospital, Kashani st.
City
Urmia
Province
West Azarbaijan
Postal code
51147
Phone
+98 44 3232 7077
Email
samiraesmaili2019@yahoo.com
Web page address
https://motahari.umsu.ac.ir/
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 Street.Resalat Blvt, Urmia, Iran
City
urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3232 7077
Email
samiraesmaili2019@yahoo.com
Web page address
https://motahari.umsu.ac.ir/
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
Samira Esmaili
Position
Resident of Obstetrics & Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari Hospital, Kashani Street
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
+98 44 3232 7077
Email
samiraesmaili2019@yahoo.com
Web page address
https://motahari.umsu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Samira Esmaili
Position
Resident of Obstetrics & Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani street, Motahari Hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412234125
Phone
+98 44 3232 7077
Email
samiraesmaili2019@yahoo.com
Web page address
https://motahari.umsu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Samira Ssmaili
Position
Resident of Obstetrics & Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani St, Motahary Hospital
City
Urmia
Province
West Azarbaijan
Postal code
04412237077
Phone
+98 44 3232 7077
Email
samiraesmaili2019@yahoo.com
Web page address
https://motahari.umsu.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