Metformin Versus Placebo from First Trimester to Delivery in Polycystic Ovary Syndrome: A Randomized, Controlled Multicenter Study
| Autor: | Sissel Hjelle, Ingunn Almås, Karin Flo, Gulim Lahmami, Odrun Kleggetveit, Kristin Skogøy, Torunn Eikeland, Eszter Vanky, Anna Danielson, Agnethe Lund, Philip von Brandis, Pål Richard Romundstad, Ann Hilde Berg, Cecilie Bjerke, Gabor Bunford, Runa Heimstad, Sven M. Carlsen, Solhild Stridsklev, Kristin Flaten Berg |
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| Rok vydání: | 2010 |
| Předmět: |
Pregnancy
medicine.medical_specialty endocrine system diseases business.industry Obstetrics Endocrinology Diabetes and Metabolism Biochemistry (medical) Clinical Biochemistry nutritional and metabolic diseases medicine.disease Placebo Biochemistry Polycystic ovary Preeclampsia Metformin law.invention Gestational diabetes Endocrinology Randomized controlled trial law Diabetes mellitus medicine business medicine.drug |
| Zdroj: | The Journal of Clinical Endocrinology & Metabolism. 95:E448-E455 |
| ISSN: | 1945-7197 0021-972X |
| DOI: | 10.1210/jc.2010-0853 |
| Popis: | Context: Metformin is widely prescribed to pregnant women with polycystic ovary syndrome (PCOS) in an attempt to reduce pregnancy complications. Metformin is not approved for this indication, and evidence for this practice is lacking. Objectives: Our objective was to test the hypothesis that metformin, from first trimester to delivery, reduces pregnancy complications in women with PCOS. Design and Setting: We conducted a randomized, placebo-controlled, double-blind, multicenter study at 11 secondary care centers. Participants: The participants were 257 women with PCOS, in the first trimester of pregnancy, aged 18–42 yr. Intervention: We randomly assigned 274 singleton pregnancies (in 257 women) to receive metformin or placebo, from first trimester to delivery. Main Outcome Measures: The prevalence of preeclampsia, gestational diabetes mellitus, preterm delivery, and a composite of these three outcomes is reported. Results: Preeclampsia prevalence was 7.4% in the metformin group and 3.7% in the placebo group (3.7%; 95% CI, −1.7–9.2) (P = 0.18). Preterm delivery prevalence was 3.7% in the metformin group and 8.2% in the placebo group (−4.4%; 95%, CI, −10.1–1.2) (P = 0.12). Gestational diabetes mellitus prevalence was 17.6% in the metformin group and 16.9% in the placebo group (0.8%; 95% CI, −8.6–10.2) (P = 0.87). The composite primary endpoint prevalence was 25.9 and 24.4%, respectively (1.5%; 95% CI, −8.9–11.3) (P = 0.78). Women in the metformin group gained less weight during pregnancy compared with those in the placebo group. There was no difference in fetal birth weight between the groups. Conclusions: Metformin treatment from first trimester to delivery did not reduce pregnancy complications in PCOS. |
| Databáze: | OpenAIRE |
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