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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Jenny Myers
+44 (0)161 7016963
jenny.myers@manchester.ac.uk


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Be Part of Research - Trial Details - Understanding the impact of metformin on maternal health and fetal growth in pregnancies complicated by maternal diabetes
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Understanding the impact of metformin on maternal health and fetal growth in pregnancies complicated by maternal diabetes

Not Recruiting

Open to: Female

Age: Adult

Manchester

Medical Conditions

Diabetes in pregnancy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Gestational diabetes mellitus (GDM) is high blood sugar (glucose) that develops during pregnancy and usually disappears after giving birth.
The prevalence of diabetes in pregnancy is increasing rapidly. Women with a combination of diabetes and vascular disease are six times more likely to develop fetal growth restriction. This means that whilst fetal overgrowth remains a common problem in women with hyperglycaemia, a very important minority of women (~3%) will develop placental disease leading to a small for gestational age infant.
Metformin is known to reduce fetal growth in pregnancies complicated by diabetes.
Current practice is to offer metformin to all women with diabetes (type 2 and gestational) irrespective of potential risk factors for placental disease. The effect of metformin on placental function and fetal growth is poorly understood. Given the uncertainty regarding the potential benefits, but possible negative effects on placental function and fetal growth highlighted by recent research, a trial of metformin in women hyperglycaemia and risk factors for placental disease is urgently needed.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Oct 2021 30 Apr 2025

As part of routine care participants will be asked to monitor blood glucose levels at home. Participants will also be provided with diet and lifestyle advice to help improve glucose levels. If levels remain above the targets set for participants, we will discuss with participants the need for treatment with metformin tablets.
• Participants will be randomly allocated to treatment with diet & lifestyle (and insulin if required) or diet & lifestyle, metformin (and insulin if required)
• Participants will be asked to have an appointment and ultrasound scan (including 3D thigh volume measurements) every 4 weeks during pregnancy
• We will ask to record weight and take skinfold measurements and blood samples (2 teaspoons) from participants at each hospital visit as part of the research
• We will ask to collect placenta and some blood samples from the baby’s umbilical cord after birth
• We will record information regarding participants, pregnancy and the baby’s birth details which will be stored on our protected research database
• We will ask to take some measurements from the baby after he/she is born which use a tape measure and skin callipers used to measure baby’s skinfold thickness
• We will ask participants to visit the clinic with baby at 3-6 and 12 months of age for further measurements of weight and growth. At these visit we will ask to take blood samples from participants and measure height, weight and skinfold thickness.


Women with type 2 diabetes and GDM, who have concomitant risk factors for the development of placental disease, for whom metformin would be routinely recommended

You can take part if:



You may not be able to take part if:


1. Medical contraindication to metformin2. Known diagnosis of Type 1 diabetes3. Multifetal pregnancy4. Prior pregnancy complicated by shoulder dystocia


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Manchester University Foundation Trust
    Oxford Rd
    Manchester
    M13 9WL

Benefit: potential reduction in the need for insulin injections
The major potential disadvantage of taking part is that for women allocated to the ‘no metformin’ part of the study, insulin injections to control blood glucose levels may be required sooner than if metformin had been prescribed. However, we know that insulin is safe in pregnancy and is used in many hospitals as the first line treatment for diabetes in pregnancy.

Prof Jenny Myers
+44 (0)161 7016963
jenny.myers@manchester.ac.uk



The study is sponsored by University of Manchester and funded by H2020 European Research Council.




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Read full details for Trial ID: ISRCTN13866189
Last updated 06 June 2025

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