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Completed

NCT Number: NCT03259919

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

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 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

metformin

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Acronym: pilPregMet

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Aug 24, 2017
Registry last updated
Oct 18, 2018

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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