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Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maurizio Guido, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01594697
First received: May 7, 2012
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594697

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

No publications provided

Responsible Party: Maurizio Guido, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01594697     History of Changes
Other Study ID Numbers: 000082011
Study First Received: May 7, 2012
Last Updated: May 10, 2012
Health Authority: Italy:Catholic University of Sacred Heart

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013