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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT03259919
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo 1 tablet x 2 daily
Metformin	Metformin	Metformin 850 mg x 2 daily

Primary Outcome Measures

Name	Time	Method
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)
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
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
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)
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

Name	Time	Method
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
Pregnancy outcome - gestational age	after delivery	Gestational age at birth (days)
Pregnancy outcome - gestational length	after delivery	Gestational length (cm) measured at birth
Pregnancy outcome - head circumference	after delivery	Head circumference (cm) measured at birth.
Pregnancy outcome - birthweight	after delivery	Birthweight (g) measured at birth
Pregnancy outcome - placental weight	after delivery	Placental weight (g) measured at birth
Pregnancy outcome - Agpar score at 5 minutes	after delivery	Apgar score at 5 minutes
Pregnancy outcome - Agpar score at 10 minutes	after delivery	Apgar score at 10 minutes
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)

Trial Locations

Locations (1)

Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital; 🇳🇴 Trondheim, Norway