| Title |
Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial
|
|---|---|
| Published in |
BMC Pregnancy and Childbirth, July 2016
|
| DOI | 10.1186/s12884-016-0954-4 |
| Pubmed ID | |
| Authors |
Denice S. Feig, Kellie Murphy, Elizabeth Asztalos, George Tomlinson, Johanna Sanchez, Bernard Zinman, Arne Ohlsson, Edmond A. Ryan, I. George Fantus, Anthony B. Armson, Lorraine L. Lipscombe, Jon F.R. Barrett, on behalf of the MiTy Collaborative Group |
| Abstract |
The 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. The 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. The 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. ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 326 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 326 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 43 | 13% |
| Student > Master | 41 | 13% |
| Researcher | 35 | 11% |
| Student > Doctoral Student | 18 | 6% |
| Student > Ph. D. Student | 17 | 5% |
| Other | 50 | 15% |
| Unknown | 122 | 37% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 80 | 25% |
| Nursing and Health Professions | 45 | 14% |
| Psychology | 13 | 4% |
| Pharmacology, Toxicology and Pharmaceutical Science | 12 | 4% |
| Biochemistry, Genetics and Molecular Biology | 7 | 2% |
| Other | 34 | 10% |
| Unknown | 135 | 41% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 27 November 2020.
All research outputs
#13,525,939
of 22,940,083 outputs
Outputs from BMC Pregnancy and Childbirth
#2,514
of 4,217 outputs
Outputs of similar age
#197,696
of 363,463 outputs
Outputs of similar age from BMC Pregnancy and Childbirth
#59
of 94 outputs
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