Metformin in Pregnant PCOS Women - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00159536

Purpose

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: Metformin Drug: Placebo Dietary Supplement: Diet and lifestyle advices	Phase III

MedlinePlus related topics: Diets

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

To investigate the incidence of pregnancy complications and pregnancy outcome in PCOS women with special focus on [ Time Frame: We are assessing outcome measures continously. Double blinded, of course ] [ Designated as safety issue: Yes ]
a)Gestational diabetes, b)Preterm delivery, c)Preeclampsia. [ Time Frame: We are assessing outcome measures continously, (double blinded of course) ] [ Designated as safety issue: Yes ]
To register the incidence of metabolic syndrome and neurophysiologic parameters in offspring [ Time Frame: Within 18 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate: 1)emesis and hyperemesis in pregnancy, 2) weight development, blood pressure in participants during pregnancy, 3)Incident of instrumental deliveries, 4)Hormone levels in mother and offspring, 5)Snoring and sleep quality [ Time Frame: We are assessing outcome measures continously, (double blinded of course) ] [ Designated as safety issue: Yes ]
6)Breastfeeding [ Time Frame: One year post partum ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	February 2005
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Metformin 1000mg x 2 daily	Drug: Metformin Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery Dietary Supplement: Diet and lifestyle advices Verbal and written advices at inclusion to the study.
2: Placebo Comparator Placebo x 2 daily	Drug: Placebo Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery Dietary Supplement: Diet and lifestyle advices Verbal and written advices at inclusion to the study.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-45 years,
PCOS diagnosis according to Rotterdam criteria
single, viable, ultrasound verified fetus
if metformin was used at conception and early pregnancy, at least 7 days of "wash out"

Exclusion Criteria:

known liver disease or ALAT > 90 nmol/L
known renal disease or creatinine > 110 micromol/L
diabetes mellitus
alcohol or drug abuse
peroral steroid treatment
cimetidine, anticoagulant or erythromycin treatment at time of inclusion
not suitable for other reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159536

Locations

Norway
Dept. of Obstetrics and Gynecology, University Hospital of Trondheim
Trondheim, Norway, 7006

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Investigators

Principal Investigator:

Eszter I Vanky, MD, PhD

Norwegian University of Science and Technology

More Information

No publications provided

Responsible Party:	Dept. of Obstetrics and Gynecology, St. Olavs Hospital, Norwegian University of Science and Technology ( Eszter Vanky MD, PhD )
Study ID Numbers:	PregMet
Study First Received:	September 8, 2005
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00159536 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

PCOS
metformin
pregnancy

preeclampsia
diabetes
preterm delivery

Study placed in the following topic categories:

Gonadal Disorders
Metformin
Diabetes Mellitus
Pre-Eclampsia
Endocrine System Diseases
Ovarian Diseases
Cysts
Preeclampsia

Polycystic Ovarian Syndrome
Genital Diseases, Female
Hypoglycemic Agents
Polycystic Ovary Syndrome
Endocrinopathy
Ovarian Cysts
Premature Birth

Additional relevant MeSH terms:

Disease
Gonadal Disorders
Physiological Effects of Drugs
Metformin
Endocrine System Diseases
Ovarian Diseases
Cysts
Pharmacologic Actions

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Hypoglycemic Agents
Pathologic Processes
Syndrome
Polycystic Ovary Syndrome
Ovarian Cysts

ClinicalTrials.gov processed this record on May 06, 2009