Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin

• Registration Number: NCT01594697
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
incidence of gestational diabetes

Secondary Outcome Measures

Name	Time	Method
number of newborns with macrosomia
rate of spontaneous abortion
number of hypertensive disorders
number of live births
incidence of delivery by caesarian section

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy