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Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01594697
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : May 11, 2012
Information provided by (Responsible Party):

May 7, 2012
May 9, 2012
May 11, 2012
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incidence of gestational diabetes
Same as current
Complete list of historical versions of study NCT01594697 on ClinicalTrials.gov Archive Site
  • rate of spontaneous abortion
  • number of hypertensive disorders
  • number of live births
  • number of newborns with macrosomia
  • incidence of delivery by caesarian section
  • rate of spontaneous abortion
  • hypertensive disorders
  • live births
  • macrosomia
  • caesarian section
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Metformin in Pregnancy in Women With Polycystic Ovary Syndrome
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The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation.
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
Drug: Metformin
Experimental: metformin
Intervention: Drug: Metformin
Romualdi D, De Cicco S, Gagliano D, Busacca M, Campagna G, Lanzone A, Guido M. How metformin acts in PCOS pregnant women: insights into insulin secretion and peripheral action at each trimester of gestation. Diabetes Care. 2013 Jun;36(6):1477-82. doi: 10.2337/dc12-2071. Epub 2013 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • age 18-40 yr,
  • metformin treatment for at least 3 months before entering the pregnancy,
  • gestational age between 5 and 12 wk

Exclusion Criteria:

  • diabetes mellitus
  • significant liver or renal impairment
  • neoplasms and other endocrine diseases
  • the use of drugs other than metformin able to interfere with glucose and insulin metabolism.
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
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Contact information is only displayed when the study is recruiting subjects
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Maurizio Guido, Catholic University of the Sacred Heart
Catholic University of the Sacred Heart
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Catholic University of the Sacred Heart
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP