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Completed

NCT Number: NCT00159536

Metformin in Pregnant PCOS Women

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hypertension, Pregnancy-Induced Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Ovarian Cysts Ovarian Diseases Pre-Eclampsia Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University hospital of Bergen, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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 names: metformin from Weifa 500 mg / tablet

Placebo

Drug

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 names: Placebo from Weifa

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

Acronym: PregMet

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2005
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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