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

Polycystic Ovary Syndrome Clinical Trial

— pilPregMet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259919
• Other study ID #: 220800
• Status: Completed
• Phase: Phase 2
• Start date: October 2000
• Est. completion date: March 2003

Study information

• Verified date: October 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Hanem LGE, Stridsklev S, Júlíusson PB, Salvesen Ø, Roelants M, Carlsen SM, Ødegård R, Vanky E. Metformin Use in PCOS Pregnancies Increases the Risk of Offspring Overweight at 4 Years of Age: Follow-Up of Two RCTs. J Clin Endocrinol Metab. 2018 Apr 1;103(4 — View Citation

Vanky E, Salvesen KA, Heimstad R, Fougner KJ, Romundstad P, Carlsen SM. Metformin reduces pregnancy complications without affecting androgen levels in pregnant polycystic ovary syndrome women: results of a randomized study. Hum Reprod. 2004 Aug;19(8):1734 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dehydroepiandrosterone sulfate (DHEAS)	(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)	up to delivery
Primary	Androstenedione	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	up to delivery
Primary	Testosterone	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	up to delivery
Primary	Sex hormone binding globulin (SHBG)	(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)	up to delivery
Primary	Free testosterone index	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)	up to delivery
Secondary	Occurence of pregnancy complications	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	up to 6 weeks post partum
Secondary	Pregnancy outcome - gestational age	Gestational age at birth (days)	after delivery
Secondary	Pregnancy outcome - gestational length	Gestational length (cm) measured at birth	after delivery
Secondary	Pregnancy outcome - head circumference	Head circumference (cm) measured at birth.	after delivery
Secondary	Pregnancy outcome - birthweight	Birthweight (g) measured at birth	after delivery
Secondary	Pregnancy outcome - placental weight	Placental weight (g) measured at birth	after delivery
Secondary	Pregnancy outcome - Agpar score at 5 minutes	Apgar score at 5 minutes	after delivery
Secondary	Pregnancy outcome - Agpar score at 10 minutes	Apgar score at 10 minutes	after delivery
Secondary	Pregnancy outcome - umbilical artery pH	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)	after delivery