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Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT01594697
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : May 11, 2012
Sponsor:
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Arms and Interventions
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Arm Intervention/treatment
Experimental: metformin Drug: Metformin


Outcome Measures
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Primary Outcome Measures :
  1. incidence of gestational diabetes

Secondary Outcome Measures :
  1. rate of spontaneous abortion
  2. number of hypertensive disorders
  3. number of live births
  4. number of newborns with macrosomia
  5. incidence of delivery by caesarian section

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

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594697


Locations
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Italy
Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maurizio Guido, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01594697     History of Changes
Other Study ID Numbers: 000082011
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs