Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial

BMC Pregnancy and Childbirth

Study Protocol

Anthony B. Armson¹  Lorraine L. Lipscombe²  Arne Ohlsson³  Kellie Murphy⁴  I. George Fantus⁵  Denice S. Feig⁵  Bernard Zinman⁵  Elizabeth Asztalos⁶  Jon F.R. Barrett⁷  Johanna Sanchez⁸  George Tomlinson⁹  Edmond A. Ryan^1,10 

[1] Dalhousie University, Halifax, Nova Scotia, Canada;Department of Medicine, University of Toronto, Toronto, Canada;Women’s College Hospital, Toronto, Ontario, Canada;Mount Sinai Hospital, 60 Murray St., Lebovic Building, Suite 5027, M5T 3L9, Toronto, Ontario, Canada;Department of Paediatics, University of Toronto, Toronto, Canada;Mount Sinai Hospital, 60 Murray St., Lebovic Building, Suite 5027, M5T 3L9, Toronto, Ontario, Canada;Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada;Mount Sinai Hospital, 60 Murray St., Lebovic Building, Suite 5027, M5T 3L9, Toronto, Ontario, Canada;Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada;Department of Medicine, University of Toronto, Toronto, Canada;Sunnybrook Health Sciences Centre Toronto, Toronto, Canada;Sunnybrook Research Institute Toronto, Toronto, Ontario, Canada;Sunnybrook Health Sciences Centre Toronto, Toronto, Canada;Sunnybrook Research Institute Toronto, Toronto, Ontario, Canada;The Centre for Mother, Infant and Child Research (CMICR), Toronto, Ontario, Canada;Sunnybrook Research Institute Toronto, Toronto, Ontario, Canada;The Centre for Mother, Infant and Child Research (CMICR), Toronto, Ontario, Canada;University Health Network, Toronto, Canada;Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada;University of Alberta, Edmonton, Canada;

关键词: Diabetes Mellitus;    Pregnancy;    Pregnancy in diabetics;    Metformin;    Diabetes Mellitus Type 2;    Pregnancy outcome;    Randomized controlled trial;   

DOI  :  10.1186/s12884-016-0954-4

 received in 2015-12-24, accepted in 2016-07-09,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy.MethodsThe MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18–45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants.DiscussionThe results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population.Trial registrationClinicalTrials.gov Identifier: no. NCT01353391. Registered February 6, 2009.

【 授权许可】

CC BY   
© The Author(s). 2016