Back to resultsMetformin in Pregnancy in Women With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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.
Sites / Locations
- Catholic University of Sacred Heart
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
metformin
Arm Description
Outcomes
Primary Outcome Measures
incidence of gestational diabetes
Secondary Outcome Measures
rate of spontaneous abortion
number of hypertensive disorders
number of live births
number of newborns with macrosomia
incidence of delivery by caesarian section
Full Information
NCT ID
NCT01594697
First Posted
May 7, 2012
Last Updated
May 10, 2012
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01594697
Brief Title
Metformin in Pregnancy in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
incidence of gestational diabetes
Secondary Outcome Measure Information:
Title
rate of spontaneous abortion
Title
number of hypertensive disorders
Title
number of live births
Title
number of newborns with macrosomia
Title
incidence of delivery by caesarian section
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23315599
Citation
Romualdi D, De Cicco S, Gagliano D, Busacca M, Campagna G, Lanzone A, Guido M. How metformin acts in PCOS pregnant women: insights into insulin secretion and peripheral action at each trimester of gestation. Diabetes Care. 2013 Jun;36(6):1477-82. doi: 10.2337/dc12-2071. Epub 2013 Jan 11.
Results Reference
derived
Learn more about this trial
Metformin in Pregnancy in Women With Polycystic Ovary Syndrome
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