ArticleBMJ open2019
A double blind, randomised, placebo-controlled trial to evaluate the efficacy of metformin to treat preterm pre-eclampsia (PI2 Trial): study protocol.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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Who cites it
22 citing papers in PubMed, 46 citations in OpenAlex.
- Use of metformin to prolong gestation in preterm pre-eclampsia: randomised, double blind, placebo controlled trial.BMJ (Clinical research ed.) · 2021Trial
- Temporizing management vs immediate delivery in early-onset severe preeclampsia between 28 and 34 weeks of gestation (TOTEM study): An open-label randomized controlled trial.Acta obstetricia et gynecologica Scandinavica · 2021Trial
- Article
- AMPK: Accumulating Evidence in Support of its role in Dual Regulation of Vascular Function and Metabolism During Human Pregnancy.Acta physiologica (Oxford, England) · 2025Review
- Evaluating oxidative stress targeting treatments inFrontiers in cell and developmental biology · 2025Article
- Article
- First Trimester Preeclampsia Screening and Prevention: Perspective in Chinese Mainland.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2024Article
- Impact of fetal growth restriction on pregnancy outcome in women undergoing expectant management for preterm pre-eclampsia.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2023Article
- A Balancing Act: Navigating Hypertensive Disorders of Pregnancy at Very Advanced Maternal Age, from Preconception to Postpartum.Journal of clinical medicine · 2023Review
- Associations Between Soluble fms-Like Tyrosine Kinase-1 and Placental Growth Factor and Disease Severity Among Women With Preterm Eclampsia and Preeclampsia.Journal of the American Heart Association · 2022Article
- Mitochondrial Dysfunction in the Pathogenesis of Preeclampsia.Current hypertension reports · 2022Review
- Programming of cardiometabolic health: the role of maternal and fetal hyperinsulinaemia.The Journal of endocrinology · 2022Review
- Circulating SPINT1 Is Reduced in a Preeclamptic Cohort with Co-Existing Fetal Growth Restriction.Journal of clinical medicine · 2022Article
- Maternal but not fetoplacental health can be improved by metformin in a murine diet-induced model of maternal obesity and glucose intolerance.The Journal of physiology · 2022Article
- Bioenergetics adaptations and redox homeostasis in pregnancy and related disorders.Molecular and cellular biochemistry · 2021Review
- First pregnancy risk factors and future gestational diabetes mellitus.Archives of gynecology and obstetrics · 2021Article
- Interaction between Metformin, Folate and Vitamin BInternational journal of molecular sciences · 2021Review
- Improvement Effect of Metformin on Female and Male Reproduction in Endocrine Pathologies and Its Mechanisms.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Article
- Current Researches, Rationale, Plausibility, and Evidence Gaps on Metformin for the Management of Hypertensive Disorders of Pregnancy.Frontiers in pharmacology · 2020Review
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Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPre-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).
methodsThe 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.
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