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Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

This study has been completed.
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart Identifier:
First received: May 7, 2012
Last updated: May 10, 2012
Last verified: May 2012
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.

Condition Intervention
Polycystic Ovary Syndrome Drug: Metformin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Maurizio Guido, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • incidence of gestational diabetes

Secondary Outcome Measures:
  • rate of spontaneous abortion
  • number of hypertensive disorders
  • number of live births
  • number of newborns with macrosomia
  • incidence of delivery by caesarian section

Enrollment: 60
Arms Assigned Interventions
Experimental: metformin Drug: Metformin


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female

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.
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Please refer to this study by its identifier: NCT01594697

Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Maurizio Guido, Principal Investigator, Catholic University of the Sacred Heart Identifier: NCT01594697     History of Changes
Other Study ID Numbers: 000082011
Study First Received: May 7, 2012
Last Updated: May 10, 2012

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017