Obesity in pregnancy MedDRA version: 15.0 Level: PT Classification code 10036556 Term: Pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 15.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: metformin
Product Name: Glucophage 500mg film-coated tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: Glucophage
Othe
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Caucasian obese (BMI = 30 kg/m2) pregnant women between = 12-0 and = 16+0 weeks gestation Women age =16 years Signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Non Caucasian women • Women with a BMI = 29 kg/m2 • Gestation > than 16 weeks • Women with pre-existing diabetes • Women with gestational diabetes in a previous pregnancy • Women with systemic disease requiring medication. • Gestational diabetes in index pregnancy (diagnosed with 75g OGTT tested (WHO criteria prior to randomisation) • A known pregnancy complications in this or a previous pregnancy likely to impact of birthweight or gestation at delivery • A known hypersensitivity to metformin hydrochloride or to any of the excipient. • Known abnormalities of the liver (tested prior to randomisation) • Renal failure or renal dysfunction • Acute conditions with the potential to alter renal function such as: o dehydration, o severe infection, o shock, o intravascular administration of iodinated contrast agents o Acute or chronic diseases which may cause tissue hypoxia such as: o cardiac or respiratory failure, o recent myocardial infarction, o shock o hepatic insufficiency, acute alcohol intoxication, alcoholism, • Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to determine if metformin, administered to obese women during pregnancy, reduces the future life risk of obesity and metabolic syndrome in their babies. ;Secondary Objective: We will use metformin administration as a tool to explore the mechanism by which obesity causes adverse pregnancy outcomes, with a particular focus on insulin resistance (IR). ; Primary end point(s): 1. What is the efficacy of metformin (up to 2500mg daily), given to obese pregnant women from 12 - 16 weeks gestation until delivery in reducing birthweight centile of the baby? 2. What is the pattern of association between insulin resistance and adverse pregnancy outcome in obese pregnant women? | — |
Countries
United Kingdom
Contacts
Public ContactMarise Bucukoglu
University of Edinburgh
Outcome results
None listed