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Metformin in Pregnant PCOS Women (PregMet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00159536
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)
Study Start Date : February 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Metformin
Metformin 1000mg x 2 daily
 Drug: Metformin
Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Other Name: metformin from Weifa 500 mg / tablet
Placebo Comparator: placebo
Placebo x 2 daily
 Drug: Placebo
Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Other Name: Placebo from Weifa


Outcome Measures
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Primary Outcome Measures :
  1. Gestational diabetes [ Time Frame: up to delivery ]
  2. incidence of metabolic syndrome and neurophysiologic parameters in offspring [ Time Frame: Within 18 years ]
  3. Preterm delivery [ Time Frame: up to delivery ]
  4. pre-eclampsia [ Time Frame: up to delivery ]

Secondary Outcome Measures :
  1. emesis and hyperemesis [ Time Frame: up to delivery ]
  2. Breastfeeding [ Time Frame: One year post partum ]
  3. weight change [ Time Frame: up to delivery ]
  4. blood pressure change [ Time Frame: up to delivery ]
  5. Incident of instrumental deliveries [ Time Frame: at delivery ]
  6. Hormone levels in mother and offspring [ Time Frame: up to delivery ]
  7. Snoring and sleep quality [ Time Frame: up to delivery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159536


Locations
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Norway
University hospital of Bergen
Bergen, Norway
Central Hospital of Northern Norway
Bodø, Norway
Buskerud Hospital
Drammen, Norway
Haugesund Hospital
Haugesund, Norway
Ringerike Hospital
Hønefoss, Norway
Elvebredden Gynekologpraksis
Kristiansand, Norway
Lillehammer Hospital
Lillehammer, Norway
Stavanger University Hospital
Stavanger, Norway
Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital
Trondheim, Norway
Ålesund Hospital
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Principal Investigator: Eszter I Vanky, MD, PhD Norwegian University of Science and Technology
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00159536    
Other Study ID Numbers: PregMet
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
PCOS
metformin
pregnancy
 preeclampsia
diabetes
preterm delivery
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs