Gestational Diabetes Mellitus in obese pregnant women.
Conditions
Interventions
Intervention 1: 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. Intervention 2: Control group: They will not be prescribed medication and will undergo routine pregnancy care and follow-up.
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: Age >16 years Gestational age <3 months Singleton pregnancy Body mass index =30
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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.;Final dosage of administered insulin at the time of delivery. Timepoint: One day prior to delivery. Method of measurement: Patient documentations.;The incidence of polyhydramnios. Timepoint: Final pregnancy trimester. Method of measurement: Ultrasound imaging.;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.;Frequency of performed Cesarean Sections. Timepoint: At the time of delivery. Method of measurement: Hospitalization documents or by researcher designed questionnaire.;Frequency of hospitalization at the neonatal intensive care unit. Timepoint: At the time of birth. Method of measurement: Researcher designed questionnaire or hospitalization documentations. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShiva Ghayor
Oroumia University of Medical Sciences
Outcome results
None listed