June 14, 2024

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Promising gestational diabetes treatment for pregnant women

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Metformin offers pregnant women hope as an effective alternative for gestational diabetes treatment and management worldwide

Scientists at the University of Galway have made notable progress in treating gestational diabetes mellitus following a clinical study involving pregnant women, offering renewed optimism to pregnant women dealing with this condition.

The findings from the trial were published in JAMA, the Journal of American Medical Association. 

Gestational diabetes

Gestational diabetes is a worldwide health concern, impacting nearly 3 million expecting mothers annually. This condition is marked by elevated glucose levels during pregnancy, presenting heightened health hazards for mothers and infants.

Professor Fidelma Dunne, who is the Professor of Medicine at the University of Galway and serves as a Consultant Endocrinologist at the Saolta University Health Care Group, led the EMERGE trial, which was a randomised, placebo-controlled study involving over 500 pregnant women.

The findings of the study revealed:

  1. Women who were prescribed metformin were 25% less likely to require insulin, and when insulin was necessary, it was taken later during pregnancy. Metformin is a commonly used medication for managing Type 2 Diabetes and has been readily available for over six decades.
  2. The metformin-exposed group exhibited significantly lower fasting and post-meal sugar levels in the mother at weeks 32 and 38 of pregnancy.
  3. Women who received metformin gained less weight throughout the trial, and this weight difference was maintained at the 12-week post-delivery follow-up.
  4. The average gestational age at delivery was the same (39.1 weeks) in both groups. There was no indication of an increased incidence of preterm birth (birth before 37 weeks) among those who received metformin.
  5. Newborns born to mothers who received metformin had an average weight of 113g less at birth, with significantly fewer infants classified as large or weighing over 4kg (8lbs 8 ounces).
  6. Although there was a slight reduction in infant length (0.7cm), there were no other noteworthy differences in baby measurements.
  7. There were slightly more babies classified as small at birth, but this difference did not achieve statistical significance.

Safety and compliance

Furthermore, the research findings indicated no distinctions in adverse neonatal outcomes, such as requiring intensive care for newborns, respiratory support, jaundice, congenital anomalies, birth injuries, or low blood sugar levels.

Additionally, there were no differences in the rates of labour induction, cesarean deliveries, maternal bleeding, infections, or blood pressure complications during or after childbirth.

Professor Fidelma Dunne presented the results (on Tuesday October 3, 2023) at the 59th Annual Meeting of the European Association for the Study of Diabetes in Hamburg, Germany.

Professor Dunne said: “While there is convincing evidence that improved sugar control is associated with improved pregnancy outcomes, there was uncertainty about the optimal management approach following a diagnosis of gestational diabetes.

“In our pursuit of a safe and effective treatment option, we explored an alternative approach – administering the drug metformin. A previous trial compared metformin to insulin and found it to be effective, yet concerns remained, especially regarding preterm birth and infant size.”

To address concerns comprehensively, the University of Galway team conducted a placebo-controlled trial, effectively addressing a significant gap in the field of gestational diabetes treatment.

Metformin as a gestational diabetes treatment option

A total of 535 pregnant women participated in the study, with 268 receiving metformin and 267 receiving a placebo.

An impressive 98% of the women remained in the trial until delivery, and 88% completed the 12-week post-delivery follow-up assessment.

Only 4.9% of the women had to discontinue the medication due to side effects, underscoring the safety of the interventions.

Professor Dunne said: “Traditionally, gestational diabetes has been managed initially through dietary advice and exercise, with insulin introduced if sugar levels remain sub-optimal.”

“While effective in reducing poor pregnancy outcomes, insulin use is associated with challenges, including low sugars in both the mother and infant, which may require neonatal intensive care, excess weight gain for mothers, and higher caesarean birth rates.”

“For mothers with gestational diabetes, they are also at greater risk of high blood pressure and preeclampsia.

“Babies born to mothers with gestational diabetes face their own set of risks, such as excessive weight at birth, birth injuries, respiratory difficulties and low sugar levels after delivery potentially requiring admission to neonatal intensive care.” 

Global Implications

The results from the EMERGE study are a step forward for women with gestational diabetes. Metformin has emerged as a promising and effective alternative for managing gestational diabetes, providing renewed optimism for pregnant women and healthcare professionals globally.

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