Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

May 10, 2012 updated by: Maurizio Guido, Catholic University of the Sacred Heart
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University Of Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metformin
Drug: Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
incidence of gestational diabetes

Secondary Outcome Measures

Outcome Measure
rate of spontaneous abortion
number of hypertensive disorders
number of live births
number of newborns with macrosomia
incidence of delivery by caesarian section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 7, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (Estimate)

May 9, 2012

Study Record Updates

Last Update Posted (Estimate)

May 11, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000082011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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