Polycystic Ovary Syndrome
Conditions
Brief 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.
Interventions
DRUGMetformin
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of gestational diabetes | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of spontaneous abortion | — |
| number of hypertensive disorders | — |
| number of live births | — |
| number of newborns with macrosomia | — |
| incidence of delivery by caesarian section | — |
Countries
Italy
Outcome results
None listed