EMmY: Effectiveness and acceptability of myo-inositol nutritional supplement in the prevention of gestational diabetes: a pilot placebo controlled double blind randomised trial.

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Background:

There has been an increase in Gestational Diabetes particularly among minority populations throughout the U.K. Gestational Diabetes has been linked to a number of Maternal and Fetal complications. In particular, it has been found that Women who have Gestational Diabetes will have a 70% increased risk of developing Type 2 diabetes with 10 years post-delivery. Further evidence suggests that Myo-Inositol has a promising role in preventing Gestational Diabetes by up to 60%. This is a nutritional supplement, shown to be safe during pregnancy.

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Aims:

In order to evaluate the effectiveness of administering myo-inositol to pregnant women to reduce the risk of gestational diabetes, the current study will ask the following main questions:

 

-What are the rates of recruitment and randomisation?

-What proportion of those randomised complete the study?

-What are the reasons for participation and non-participation?

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Study Start: February 2018

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Study Duration: 20 Months

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Participating Sites:

-The Royal London Hospital

-Whipps Cross University Hospital 

-Newham University Hospital 

-St. George's Hospital

-Manchester Royal Infirmary 

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Recruitment Target: 250

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https://www.isrctn.com/ISRCTN48872100