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Metformin versus placebo from first trimester to delivery in polycystic ovary syndrome: a randomized, controlled multicenter study.

AbstractCONTEXT:
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.
AuthorsEszter Vanky, Solhild Stridsklev, Runa Heimstad, Pål Romundstad, Kristin Skogøy, Odrun Kleggetveit, Sissel Hjelle, Philip von Brandis, Torunn Eikeland, Karin Flo, Kristin Flaten Berg, Gabor Bunford, Agnethe Lund, Cecilie Bjerke, Ingunn Almås, Ann Hilde Berg, Anna Danielson, Gulim Lahmami, Sven Magnus Carlsen
JournalThe Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 95 Issue 12 Pg. E448-55 (Dec 2010) ISSN: 1945-7197 [Electronic] United States
PMID20926533 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Placebos
  • Metformin
Topics
  • Adult
  • Blood Pressure
  • Delivery, Obstetric
  • Diabetes, Gestational (epidemiology)
  • Double-Blind Method
  • Female
  • Heart Rate
  • Humans
  • Metformin (therapeutic use)
  • Patient Compliance
  • Placebos
  • Polycystic Ovary Syndrome (drug therapy)
  • Pre-Eclampsia (drug therapy, epidemiology)
  • Pregnancy
  • Pregnancy Complications (drug therapy)
  • Pregnancy Trimester, First (drug effects, physiology)
  • Random Allocation

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