Metformin in Pregnant PCOS Women (PregMet)

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00159536
First received: September 8, 2005
Last updated: May 23, 2014
Last verified: May 2014
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Gestational diabetes [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • incidence of metabolic syndrome and neurophysiologic parameters in offspring [ Time Frame: Within 18 years ] [ Designated as safety issue: No ]
  • Preterm delivery [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • pre-eclampsia [ Time Frame: up to delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • emesis and hyperemesis [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • Breastfeeding [ Time Frame: One year post partum ] [ Designated as safety issue: No ]
  • weight change [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • blood pressure change [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • Incident of instrumental deliveries [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Hormone levels in mother and offspring [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • Snoring and sleep quality [ Time Frame: up to delivery ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: February 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Principal Investigator: Eszter I Vanky, MD, PhD Norwegian University of Science and Technology
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00159536     History of Changes
Other Study ID Numbers: PregMet
Study First Received: September 8, 2005
Last Updated: May 23, 2014
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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014