Gestational diabetes mellitus Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
Participants will be randomised to treatment (active or placebo) in a 1:1 ratio. Recruiting centre will be the only stratification variable, using simple randomisation under a randomly permuted block
Sponsors
University of Edinburgh
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women with a BMI = 26 kg/m2 2. Pregnant women between = 12+0 and = 28+0 weeks gestation 3. Women estimated age = 18 years 4. Women with a signed (and witnessed, if applicable) informed consent 5. Willing to be contacted, if necessary
Exclusion criteria
Exclusion criteria: 1. Conditions identified in the current pregnancy, which exclude study participation: 1.1. Women with a BMI than 28+0 weeks 1.3. Women who are known to have a multiple pregnancy at the time of trial entry 1.4. Women who are currently lactating 1.5. Women known to have diabetes 1.6. Women who have been taking HIV antiretroviral medication for less than 6 months 1.7. Women currently taking dolutegravir 1.8. Acute conditions at the time of trial entry with the potential to alter renal function such as: 1.8.1. Dehydration sufficient to require intravenous infusion 1.8.2. Severe infection 1.8.3. Shock 1.8.4. Intravascular administration of iodinated contrast agents 1.9. Acute or chronic diseases which may cause tissue hypoxia such as: 1.9.1. Cardiac or respiratory failure 1.9.2. Pancreatitis 1.9.3. Recent myocardial infarction 1.9.4. hepatic insufficiency, acute alcohol intoxication, alcoholism 2. History of the following pre-existing conditions, at the time of trial entry: 2.1. Had a previous delivery of a baby <3rd centile for gestational age (e.g. a baby born = 37 weeks gestation and the birthweight was =2.25 kg) 2.2. A known history in a previous pregnancy of gestational diabetes (needing drug treatment) 2.3. A known history of conditions affecting either the heart, lungs, liver, kidney or brain, which require regular medication at the time of recruitment 2.4. A known history of allergy to metformin or to any of the ingredients as listed in the current Summary Products Characteristics (SPC)) 2.5. Known liver failure or dysfunction at the time of trial entry 2.6. Known severe renal failure or dysfunction at the time of trial entry 2.7. Known (any type of) acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) 2.8. A previous known diabetic pre-coma 2.9. Previous known severe renal failure (GFR < 30 mL/min) Note, the exclusion conditions listed in B above do not require additional testing to identify them. It is not currently clinical practice to perform formal testing for these conditions prior to giving metformin. Additionally testing to exclude all conditions will add an additional burden to Low Middle Income Country involved. However, the investigator(s) will review the woman’s medical history by asking the woman questions and using available information to determine, if the woman has had any of these conditions. Note, although metformin is not licensed for use during pregnancy its use in this scenario is endorsed by the National Institute for Health and Care Excellence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of women recruited, expressed as a fraction of the total number of women attending for antenatal care over the recruitment period, completed after the last patient last visit 28 days postnatally | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of eligible women who are recruited into the study and provide written informed consent, completed after the last patient last visit 28 days postnatally 2. The proportion of pregnant women presenting at or before 28 weeks gestation (when the intervention will be started), calculated after the last patient last visit 28 days postnatally 3. Adherence to therapy, ascertained by review of diary and returned study medication, completed after the last patient last visit 28 days postnatally 4. Proportion of women in the placebo group and proportion of those in the active group (if tested prior to starting metformin) who have gestational diabetes at 24-30 weeks, completed after the last patient last visit 28 days postnatally 5. Ability to measure key clinical variables: 5.1. Proportion of women who are recruited but then lost to follow up for the primary and secondary outcomes, completed after the last patient last visit 28 days postnatally 5.2. Appropriate method to identify women and avoid double randomisation to address co-enrolment (i.e. GPS home identifiers, thumb or fingerprint), completed after the last patient last visit 28 days postnatally 5.3. Adverse events in each group monitored throughout the trial and presented to the Data Monitoring Committee, final presentation of the events completed after the last patient last visit 28 days postnatally | — |
Countries
Malawi
Contacts
Public ContactSonia Whyte
Outcome results
None listed