PAPAGENO

A pragmatic approach to preventing gestational diabetes and pregnancy hypertensive disorders in obese pregnant women in resource poor settings.

This is a feasibility study of a randomised clinical trial of metformin (compared with matched placebo) for the prevention of gestational diabetes and pregnancy hypertensive disorders in obese pregnant women. This study will help to determine whether we can recruit enough women to conduct a larger trial in the future, to measure if the routine administration of metformin could prevent gestational diabetes and pregnancy hypertensive disorders in obese pregnant women in resource poor settings (in Malawi and Zambia).

In this feasibility study, we will measure if women are willing to be recruited and take a medication. We will then use this information to determine, if a larger study to prevent gestational diabetes could be conducted in the future.

Chief Investigator: Jane E. Norman 

Number and location of participating sites / geographical scope (by region/ country): 1 Malawi

Funder: MRC Global

ISRCTN67684593 https://doi.org/10.1186/ISRCTN67684593

Start and End date

Of grant award: 31 December 2020

Of recruitment

Current Status: In set up       

UK GDPR privacy statement: http://www.accord.ed.ac.uk/search/node/privacy

 Website links: https://www.ed.ac.uk/centre-reproductive-health/clinical-studies

Sponsor: ACCORD http://www.accord.ed.ac.uk/

Chief Investigator:  Jane E Norman - Jane.Norman@ed.ac.uk

Trial manager:  Sonia Whyte - Clinical Trials Project Manager   Tel: 0131 242 2693   Email: sonia.whyte@ed.ac.uk / Sonia.whyte1@nhs.net

ECTU Involvement:  Statistics / Data base and randomisation service provision only