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

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT03259919
Collaborator
St. Olavs Hospital (Other)
40
Enrollment
1
Location
2
Arms
28.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
40 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: a Pilot Study
Actual Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Mar 1, 2003
Actual Study Completion Date :
Mar 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metformin

Metformin 850 mg x 2 daily

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 Names:
  • metformin from Weifa 425 mg / tablet

    		•
    Placebo Comparator: placebo

    Placebo 1 tablet x 2 daily

    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 Names:
  • Placebo from Weifa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dehydroepiandrosterone sulfate (DHEAS) [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)

    2. Androstenedione [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

    3. Testosterone [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

    4. Sex hormone binding globulin (SHBG) [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)

    5. Free testosterone index [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)

    Secondary Outcome Measures

    1. Occurence of pregnancy complications [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

    2. Pregnancy outcome - gestational age [after delivery]

      Gestational age at birth (days)

    3. Pregnancy outcome - gestational length [after delivery]

      Gestational length (cm) measured at birth

    4. Pregnancy outcome - head circumference [after delivery]

      Head circumference (cm) measured at birth.

    5. Pregnancy outcome - birthweight [after delivery]

      Birthweight (g) measured at birth

    6. Pregnancy outcome - placental weight [after delivery]

      Placental weight (g) measured at birth

    7. Pregnancy outcome - Agpar score at 5 minutes [after delivery]

      Apgar score at 5 minutes

    8. Pregnancy outcome - Agpar score at 10 minutes [after delivery]

      Apgar score at 10 minutes

    9. Pregnancy outcome - umbilical artery pH [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital Trondheim Norway

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital

    Investigators

    • Study Director: Sven M Carlsen, MD, PhD, Norwegian University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT03259919
    Other Study ID Numbers:
    • 220800
    First Posted:
    Aug 24, 2017
    Last Update Posted:
    Oct 18, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Metformin
    Pregnancy outcome
    Androgens
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Metformin

    Study Results

    No Results Posted as of Oct 18, 2018