Metformin Impact on Maternal and Infant Cardiometabolic Health (MIMICH), an open-label randomised controlled trial, and Metformin Impact on Maternal and Cardiometabolic Health After Pregnancy (MIMICH II)
Abstract
Background: Whilst women with diabetes are at risk of having a pregnancy complicated by foetal macrosomia, a small but important minority of women develop placental dysfunction leading to a small for gestational age infant (SGA < 10th centile) (20%) and/or the development of pre-eclampsia (12-18%) which may in some cases require preterm birth. In the UK, currently, metformin is offered as first line to treat diabetes during pregnancy, regardless of the risk of placental disease; however, the effect of metformin on placental function and foetal growth remains unclear. Metformin Impact on Maternal and Infant Cardiometabolic Health (MIMICH) and Metformin Impact on Maternal and Infant Cardiometabolic Health After Pregnancy (MIMICH II) aim to better understand the impact of metformin in the context of pregnancies at high risk of placental disease by evaluating the effect of metformin on foetal growth, placental function and maternal and infant cardiometabolic health.
Methods: MIMICH is a randomised control trial (RCT) comparing routine treatment for diabetes, the standard of care, to withholding metformin (the intervention) during pregnancy, in women with type 2 diabetes or gestational diabetes (GDM) who have maternal or uteroplacental risk factors for placental disease in a target sample of 225 participants. Participants receive the recommended schedule of antenatal care, including serial biometry ultrasound with the addition of fractional thigh volume measurement. The primary…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 225 participants or records.
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