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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Drug: Metformin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |

Arm | Intervention/treatment |
---|---|
Experimental: metformin |
Drug: Metformin |
- incidence of gestational diabetes
- rate of spontaneous abortion
- number of hypertensive disorders
- number of live births
- number of newborns with macrosomia
- incidence of delivery by caesarian section

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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.

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
Italy | |
Catholic University of Sacred Heart | |
Rome, Italy, 00168 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
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 |