Clinical trial NCT03259919: Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
Official title: Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Metformin
Pregnancy outcome
Androgens
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2017-08-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Dehydroepiandrosterone sulfate (DHEAS)
timeFrame: up to delivery
measure: Androstenedione
timeFrame: up to delivery
measure: Testosterone
timeFrame: up to delivery
measure: Sex hormone binding globulin (SHBG)
timeFrame: up to delivery
measure: Free testosterone index
timeFrame: up to delivery
Secondary outcomes:
measure: Occurence of pregnancy complications
timeFrame: up to 6 weeks post partum
measure: Pregnancy outcome - gestational age
timeFrame: after delivery
measure: Pregnancy outcome - gestational length
timeFrame: after delivery
measure: Pregnancy outcome - head circumference
timeFrame: after delivery
measure: Pregnancy outcome - birthweight
timeFrame: after delivery
measure: Pregnancy outcome - placental weight
timeFrame: after delivery
measure: Pregnancy outcome - Agpar score at 5 minutes
timeFrame: after delivery
measure: Pregnancy outcome - Agpar score at 10 minutes
timeFrame: after delivery
measure: Pregnancy outcome - umbilical artery pH
timeFrame: after delivery
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Sven M Carlsen, MD, PhD
role: STUDY_DIRECTOR
References:
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):1734-40. doi: 10.1093/humrep/deh347. Epub 2004 Jun 3.
citation: Hanem LGE, Stridsklev S, Juliusson PB, Salvesen O, Roelants M, Carlsen SM, Odegard 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):1612-1621. doi: 10.1210/jc.2017-02419.
citation: Trouva A, Alvarsson M, Calissendorff J, Asvold BO, Vanky E, Hirschberg AL. Thyroid Status During Pregnancy in Women With Polycystic Ovary Syndrome and the Effect of Metformin. Front Endocrinol (Lausanne). 2022 Feb 21;13:772801. doi: 10.3389/fendo.2022.772801. eCollection 2022.
citation: Underdal MO, Salvesen O, Henriksen AH, Andersen M, Vanky E. Impaired Respiratory Function in Women With PCOS Compared With Matched Controls From a Population-Based Study. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz053. doi: 10.1210/clinem/dgz053.
citation: Underdal MO, Stridsklev S, Oppen IH, Hogetveit 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.