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NCT01594697 Clinical Trial

Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01594697
Other study ID # 000082011
Secondary ID
Status Completed
Phase N/A
First received May 7, 2012
Last updated May 10, 2012

Study information
Verified date May 2012
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority Italy:Catholic University of Sacred Heart
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin

Locations
Country Name City State
Italy Catholic University of Sacred Heart Rome

Sponsors (1)
Lead Sponsor Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of gestational diabetes
Secondary rate of spontaneous abortion
Secondary number of hypertensive disorders
Secondary number of live births
Secondary number of newborns with macrosomia
Secondary incidence of delivery by caesarian section
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