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Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study (pilPregMet)

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ClinicalTrials.gov Identifier: NCT03259919
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE August 17, 2017
First Posted Date  ICMJE August 24, 2017
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE October 2000
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: up to delivery ]
    (µmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)
  • Androstenedione [ Time Frame: up to delivery ]
    Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. measured by a double antibody technique on an Elecsys 2010 analyser (Roche Diagnostics GmbH, Germany) using reagents and calibrators supplied by the manufacturer
  • Testosterone [ Time Frame: up to delivery ]
    Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. measured by a double antibody technique on an Elecsys 2010 analyser (Roche Diagnostics GmbH, Germany) using reagents and calibrators supplied by the manufacturer
  • Sex hormone binding globulin (SHBG) [ Time Frame: up to delivery ]
    (nmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)
  • Free testosterone index [ Time Frame: up to delivery ]
    Calculated as total testosterone divided by SHBG and multiplied by a factor of 100. SHBG measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03259919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2017)
  • Occurence of pregnancy complications [ Time Frame: up to 6 weeks post partum ]
    Gestational diabetes (GDM) defined according to World Health Organization (1998) criteria, i.e. 2 h plasma glucose values ≥7.8 mmol/l during an Oral Glucose Tolerance Test (OGTT) with 75 g. Uncomplicated GDM treated with dietary advice only was not ranked among the complications in this study. Pre-eclampsia defined as a blood pressure ≥140/90mmHg with concomitant albuminuria ≥0.3 g/24 h measured on two separate occasions after gestational week 20. Premature delivery was defined as delivery before gestational week 37 + 0 according to an estimated date of delivery, based on mid-trimester ultrasound scan
  • Pregnancy outcome - gestational age [ Time Frame: after delivery ]
    Gestational age at birth (days)
  • Pregnancy outcome - gestational length [ Time Frame: after delivery ]
    Gestational length (cm) measured at birth
  • Pregnancy outcome - head circumference [ Time Frame: after delivery ]
    Head circumference (cm) measured at birth.
  • Pregnancy outcome - birthweight [ Time Frame: after delivery ]
    Birthweight (g) measured at birth
  • Pregnancy outcome - placental weight [ Time Frame: after delivery ]
    Placental weight (g) measured at birth
  • Pregnancy outcome - Agpar score at 5 minutes [ Time Frame: after delivery ]
    Apgar score at 5 minutes
  • Pregnancy outcome - Agpar score at 10 minutes [ Time Frame: after delivery ]
    Apgar score at 10 minutes
  • Pregnancy outcome - umbilical artery pH [ Time Frame: after delivery ]
    Umbilical artery pH measured in umbilical artery blood, immediately after delivery on a Rapidlab 248pH/Blood Gas Analyzer, using reagents and calibrators supplied by the manufacturer (Bayer Corp., USA)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
Official Title  ICMJE Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: Metformin
    Metformin 850 mg x 1 per day for the first week, and 850 mg x 2 per day for the rest of the study period.. Orally. From inclusion (before gestational week 8) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.
    Other Name: metformin from Weifa 425 mg / tablet
  • Drug: Placebo
    Placebo, 2 tablets x 1 daily for the first week, and 2 tablets x 2 for the rest of the study period.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.
    Other Name: Placebo from Weifa
Study Arms  ICMJE
  • Experimental: Metformin
    Metformin 850 mg x 2 daily
    Intervention: Drug: Metformin
  • Placebo Comparator: placebo
    Placebo 1 tablet x 2 daily
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis polycystic ovary syndrome (PCOS ) before pregnancy
  • BMI 27-40 kg/m2
  • Human chorionic gonadotropin, beta subunit (HCG-beta) verified pregnancy week 5-8
  • At least one of the following criteria: (1) serum testosteron > 2,5 nmol/L; (2) Sex hormone binding globulin (SHBG) < 30 nmol; (3) Fasting C-peptid > 1,0 nmol/L; (4) Menstrual disturbances: oligo-/amenorrhea or metrorrhagia; (5) Hirsutism

Exclusion Criteria:

  • known liver disease or ALAT > 60 IU/L
  • S-creatinin > 130 micromol/L
  • diabetes mellitus
  • alcohol or drug abuse
  • peroral steroid treatment (except inhalation steroids)
  • use of cimetidine, anticoagulant, erythromycin or other macrolides
  • not suitable for other reasons
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03259919
Other Study ID Numbers  ICMJE 220800
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Study Director: Sven M Carlsen, MD, PhD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP