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:

MedlinePlus related topics: Polycystic Ovary Syndrome

Drug Information available for: Metformin Metformin hydrochloride

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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 Adnexal Diseases Cysts Endocrine System Diseases Genital Diseases, Female Gonadal Disorders Neoplasms	Ovarian Cysts Ovarian Diseases Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015

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