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Frequently Asked Questions (FAQs)

Who is organising the research?
The research has been funded by the J. P. Moulton Charitable Foundation and it is being sponsored by King’s College London and Guy’s and St Thomas NHS Foundation Trust.

The Chief Investigator is Professor Catherine Williamson, from the Division of Women and Children’s Health at King’s College London.

 

Who has reviewed the study?
Before any research study can go ahead, it must be checked by an independent Research Ethics Committee, the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) to make sure that the research is fair and transparent and that your rights and wellbeing will be protected. The London Westminster Ethics Committee has reviewed and approved this study in the UK. We will send reports to those institutions once a year to let them know how the research is going. The Research & Development team at your hospital must also approve the study.

There is also a Trial Steering Committee, including independent members, who oversees the conduct of the trial. And an independent Data Monitoring Committee, to safeguard the interests of study participants and protect the credibility and validity of the trial.

 

Can I choose which medication I'll take?
No. This is a randomised study, which means that neither you nor the doctor will decide which treatment will be given. We will enter some details about you in a computer (such as your weight and height), which will then allocate you to a treatment randomly, in the same way of tossing a coin. This study is ‘open label’, which means that both you and your doctor will know which treatment you have been prescribed.

 

Is there a risk to me and my baby?
Both drugs are prescribed for pregnant women regularly in clinical practice and doctors believe they are both safe. However extra treatment may be necessary if your blood glucose levels remain high.

These drugs do have some possible side effects that some women may have:

• Metformin: one in ten people will report feeling sick, vomiting, stomach cramps, diarrhoea and loss of appetite. One in about fifty people will report changes in taste. These side effects usually pass very quickly. One in about ten thousand people will have skin reactions, lactic acidosis and liver effects. These rare side effects get better within a few days to weeks of stopping the drug.
• UDCA: One in about fifty people will have diarrhoea. Others have reported feeling sick, vomiting, stomach cramps, but we don’t know how often. One in about ten thousand people will have a skin rash. These side effects all get better within a few days to weeks of stopping the drug.

In regards the Glucose Continuous Monitoring device, the most common risk is a minor skin reaction to the adhesives used to keep the CGM in place. Minor itch, redness, bleeding, and bruising at CGM insertion sites may occur.

 

What if I change my mind?
Whether you decide to take part in the study or not is entirely up to you. Your decision will not affect the care you or your baby receive in any way. If you agree to take part, you are free to withdraw at a later stage, without giving a reason, although you may be asked if you mind us collecting details about your labour from your NHS records. Again, it is entirely up to you if you agree to this.

 

Will this affect my care?
Whether you decide to take part or not is entirely up to you. Your decision will not affect the care you or your baby receive in any way. If you agree to take part, you are free to withdraw at a later stage without giving a reason.