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Type: Journal article
Title: A double blind, randomised, placebo-controlled trial to evaluate the efficacy of metformin to treat preterm pre-eclampsia (PI2 Trial): study protocol
Author: Cluver, C.
Walker, S.P.
Mol, B.W.
Hall, D.
Hiscock, R.
Brownfoot, F.C.
Kaitu'U-Lino, T.J.
Tong, S.
Citation: BMJ Open, 2019; 9(4):e025809-1-e025809-8
Publisher: BMJ Publishing
Issue Date: 2019
ISSN: 2044-6055
Statement of
Catherine Cluver, Susan P Walker, Ben W Mol, David Hall, Richard Hiscock, Fiona C Brownfoot, Tu’uhevaha J Kaitu’u-Lino, Stephen Tong
Abstract: INTRODUCTION:Pre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far more fetal losses. There is no definitive treatment other than delivery. A therapeutic that could quench the disease process would be useful to treat preterm pre-eclampsia, as it could allow these pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have published preclinical data to show that metformin, a drug known to be safe in pregnancy and commonly used to treat gestational diabetes, has potent biological effects making it another promising candidate to treat pre-eclampsia. Here, we describe a phase II clinical trial to examine whether administering extended-release metformin may be effective in treating women with preterm pre-eclampsia (PI2 Trial). METHODS:The PI2 Trial is a phase II, double blind, randomised controlled trial that aims to recruit 150 women with preterm pre-eclampsia (gestational age 26+0 to 31+6 weeks) who are being managed expectantly. Participants will be randomised to receive either 3 g of metformin or placebo daily. The primary outcome is time from randomisation until delivery. A delay in delivery of 5 days is assumed to be clinically relevant. The secondary outcomes will be a maternal composite and neonatal composite outcome. All other outcomes will be exploratory. We will record adverse events. ETHICS AND DISSEMINATION:This study has ethical approval (Protocol number M16/09/037 Federal Wide Assurance Number 00001372, Institutional Review Board Number IRB0005239), is registered with the Pan African Clinical Trial Registry (PACTR201608001752102) and the South African Medicine Control Council (20170322). Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:PACTR201608001752102; Pre-results.
Keywords: clinical trials; metformin; pre-eclampsia; preeclampsia; preterm preeclampsia; treatment
Rights: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
RMID: 0030113865
DOI: 10.1136/bmjopen-2018-025809
Appears in Collections:Obstetrics and Gynaecology publications

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