Metformin in Pregnant PCOS Women

Polycystic Ovary Syndrome Clinical Trial

— PregMet  

Official title:

Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159536
• Other study ID #: PregMet
• Status: Completed
• Phase: Phase 3
• Start date: February 2005
• Est. completion date: October 2009

Study information

• Verified date: February 2019
• 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: 257
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18-45 years,

• PCOS diagnosis according to Rotterdam criteria

• single, viable, ultrasound verified fetus

• if metformin was used at conception and early pregnancy, at least 7 days of "wash out"

Exclusion Criteria:

• known liver disease or ALAT > 90 nmol/L

• known renal disease or creatinine > 110 micromol/L

• diabetes mellitus

• alcohol or drug abuse

• peroral steroid treatment

• cimetidine, anticoagulant or erythromycin treatment at time of inclusion

• not suitable for other reasons

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
• Placebo
Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	University hospital of Bergen	Bergen
Norway	Central Hospital of Northern Norway	Bodø
Norway	Buskerud Hospital	Drammen
Norway	Haugesund Hospital	Haugesund
Norway	Ringerike Hospital	Hønefoss
Norway	Elvebredden Gynekologpraksis	Kristiansand
Norway	Lillehammer Hospital	Lillehammer
Norway	Stavanger University Hospital	Stavanger
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 (6)

Hanem LGE, Salvesen Ø, Juliusson PB, Carlsen SM, Nossum MCF, Vaage MØ, Ødegård R, Vanky E. Intrauterine metformin exposure and offspring cardiometabolic risk factors (PedMet study): a 5-10 year follow-up of the PregMet randomised controlled trial. Lancet — View Citation

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

Shetelig Løvvik T, Stridsklev S, Carlsen SM, Salvesen Ø, Vanky E. Cervical Length and Androgens in Pregnant Women With Polycystic Ovary Syndrome: Has Metformin Any Effect? J Clin Endocrinol Metab. 2016 Jun;101(6):2325-31. doi: 10.1210/jc.2015-3498. Epub 2 — View Citation

Underdal MO, Stridsklev S, Oppen IH, Høgetveit K, Andersen MS, Vanky E. Does Metformin Treatment During Pregnancy Modify the Future Metabolic Profile in Women With PCOS? J Clin Endocrinol Metab. 2018 Jun 1;103(6):2408-2413. doi: 10.1210/jc.2018-00485. — View Citation

Vanky E, Carlsen SM. Androgens and antimüllerian hormone in mothers with polycystic ovary syndrome and their newborns. Fertil Steril. 2012 Feb;97(2):509-15. doi: 10.1016/j.fertnstert.2011.11.021. Epub 2011 Dec 10. — View Citation

Vanky E, Stridsklev S, Heimstad R, Romundstad P, Skogøy K, Kleggetveit O, Hjelle S, von Brandis P, Eikeland T, Flo K, Berg KF, Bunford G, Lund A, Bjerke C, Almås I, Berg AH, Danielson A, Lahmami G, Carlsen SM. Metformin versus placebo from first trimester — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes		up to delivery
Primary	incidence of metabolic syndrome and neurophysiologic parameters in offspring		Within 18 years
Primary	Preterm delivery		up to delivery
Primary	pre-eclampsia		up to delivery
Secondary	emesis and hyperemesis		up to delivery
Secondary	Breastfeeding		One year post partum
Secondary	weight change		up to delivery
Secondary	blood pressure change		up to delivery
Secondary	Incident of instrumental deliveries		at delivery
Secondary	Hormone levels in mother and offspring		up to delivery
Secondary	Snoring and sleep quality		up to delivery