Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

Catholic University of the Sacred Heart60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Catholic University of Sacred Heart

Rome, Rome, Italy

Outcomes

Primary Outcomes

incidence of gestational diabetes

Secondary Outcomes

rate of spontaneous abortion

number of hypertensive disorders

number of live births

number of newborns with macrosomia

incidence of delivery by caesarian section

Data from ClinicalTrials.gov

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