Common diabetes medication can reduce preterm birth rates in high-risk pregnancies

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by Monash University

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Metformin 500mg tablets. Credit: public domain

A common diabetes medication can reduce the risk of early and preterm births for mothers at high metabolic risk, according to new research led by Monash University. Published in NEJM Evidence, the study investigated whether metformin, a low-cost oral prescription medication used to manage blood sugar, could help prevent gestational diabetes and other adverse pregnancy outcomes, including early birth.

Gestational diabetes is characterized by elevated blood sugar during pregnancy and now affects one in five pregnant women in Australia. In severe cases, it can trigger premature labor.

While metformin's long-term impacts during pregnancy continue to be studied, researchers found that metformin did not prevent gestational diabetes overall but could offer significant protective benefits against premature delivery.

Preterm birth refers to delivery before 37 weeks and remains a leading cause of mortality and morbidity for mothers and babies. In Australia, more than 26,000 babies (around 8% of all births) are born prematurely each year, placing infants at risk of respiratory distress, developmental complications and prolonged stays in neonatal intensive care.

Lower odds of early delivery

Lead author Associate Professor Aya Mousa, head of Diabetes, Metabolic and Reproductive Health Research at the Monash Center for Health Research & Implementation, said women taking metformin had 35% lower odds of giving birth prematurely (before 37 weeks) compared with those receiving a placebo.

"Metformin helps the body use insulin more effectively to lower blood sugar," Mousa said.

"We found women taking metformin had fewer births before 37 weeks.

"This included halving the rate of births before 34 weeks—down to 2.2%, compared with 4.4% in the placebo group.

"Among those who did deliver prematurely, pregnancy was prolonged by an average of 11 days for women on metformin."

Researchers analyzed individual patient data from seven randomized, placebo-controlled trials involving 2,297 pregnancies at high metabolic risk, including those with higher body weight, insulin resistance or polyendocrine metabolic ovarian syndrome (PMOS, previously known as PCOS).

Mousa said metformin's effect on preterm birth warranted further investigation.

"While these findings need to be confirmed in trials specifically designed to investigate preterm birth, including exploring optimal timing for starting metformin, they point to an important potential benefit that warrants further research," Mousa said.

Pooling data to clarify effects

The study forms part of the Metformin in Pregnancy Study (MiPS), a large international collaboration led by Monash researchers that brings together individual participant data from randomized trials involving thousands of women and examines metformin use during pregnancy.

Senior author Professor Helena Teede, director of the Monash Center for Health Research & Implementation and an endocrinologist at Monash Health, said the international collaboration helped address an important evidence gap around metformin use in pregnancy, with multiple further questions now being addressed using this important data.

"Isolated studies have previously produced mixed findings and have not been large enough to definitively determine metformin effects, including in preventing gestational diabetes," Teede said.

"By bringing together the original data from thousands of women across international trials, we could examine individual participants and account for differences such as age, body mass index, blood glucose levels and when treatment began, giving us a clearer picture of metformin's effects during pregnancy."

Metformin did not affect other pregnancy outcomes, including birth weight, high blood pressure, pre-eclampsia, induction of labor or cesarean section.

The broader MiPS collaboration is also investigating the long-term outcomes of metformin exposure during pregnancy.

Publication details

Aya Mousa et al, Metformin in High Metabolic Risk Pregnancies — A Patient-Level Meta-Analysis, NEJM Evidence (2026). DOI: 10.1056/evidoa2500337

Journal information: NEJM Evidence

Key medical concepts

MetforminPremature BirthDiabetes and PregnancyInsulin Resistance

Clinical categories

Obstetrics & gynecologyPregnancyWomen's healthEndocrinology Provided by Monash University Who's behind this story?

Sadie Harley

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