Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

Catholic University of the Sacred Heart

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01594697

000082011

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

metformin

Experimental group

Treatment:

Drug: Metformin