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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

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 2

Study Type : Interventional  (Clinical Trial)
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 : October 2000
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placebo from Weifa




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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)


Secondary Outcome Measures :
  1. 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

  2. Pregnancy outcome - gestational age [ Time Frame: after delivery ]
    Gestational age at birth (days)

  3. Pregnancy outcome - gestational length [ Time Frame: after delivery ]
    Gestational length (cm) measured at birth

  4. Pregnancy outcome - head circumference [ Time Frame: after delivery ]
    Head circumference (cm) measured at birth.

  5. Pregnancy outcome - birthweight [ Time Frame: after delivery ]
    Birthweight (g) measured at birth

  6. Pregnancy outcome - placental weight [ Time Frame: after delivery ]
    Placental weight (g) measured at birth

  7. Pregnancy outcome - Agpar score at 5 minutes [ Time Frame: after delivery ]
    Apgar score at 5 minutes

  8. Pregnancy outcome - Agpar score at 10 minutes [ Time Frame: after delivery ]
    Apgar score at 10 minutes

  9. 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)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03259919


Locations
Norway
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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03259919     History of Changes
Other Study ID Numbers: 220800
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs