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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Metformin treatment of pregnant PCOS women and prevention of preterm birth.

Awarded: NOK 9.6 mill.

The main aims of the PregMet2 study were to investigate whether metformin could prevent late miscarriage and preterm delivery in women with PCOS. Participants were included in 14 study centers, in Norway, Iceland and Sweden, from 2012 to 2017, in all 487 women. The main results are now published in Lancet Diabetes & Endocrinology February 2019. We found that metformin use in pregnancy ? reduced the prevalence of late miscarriage and preterm births ? had no effect on the prevalence or clinical course of gestational diabetes ? did not reduce the prevalence of preeclampsia ? resulted in less weight gain in pregnancy The results received a lot of international attention and will have impact on the clinical treatment and follow-up of both women with PCOS and women with gestational diabetes.

Resultater fra PregMet 2 studien sammen med PregMet1 og Pilot studien viser at metformin forebygger sene aborter og for tidlige fødsler hos kvinner med polycystisk ovariesyndrom (PCOS). Det var hovedmålet med studien. Studien viser også at metformin forebygger ikke svangerskapsdiabetes. Den har ingen effekt på sukkermetabolisme hos gravide PCOS kvinner. Det er overraskende og uventet, da metformin har en godt dokumentert effekt på type 2 diabetes hos ikke gravide. Metformin er blitt tatt i bruk for å behandle svangerskapsdiabetes og kun blitt testet mot insulin. Metformin brukes av mange millioner gravide kvinner på indikasjon svangerskapsdiabetes. Våre resultater kommer å bidra til reevaluering av bruk av metformin på indikasjon svangerskapsdiabetes. Metformin kan være en behandlingsmulighet hos gravide PCOS kvinner med økt risiko for sene aborter og preterme fødsler

Polycystic ovary syndrome (PCOS) is a common condition among women of fertile age. It may affect almost all aspects of life and reproductive health. The prevalence of pregnancy complications, such as gestational diabetes, preeclampsia, miscarriage and pre term birth seems to be increased among these women. The prevalence of PCOS in a normal population in Norway is about 15%. The prevalence of PCOS among women who have experienced preterm delivery is 28%. Pooled data from two former RCTs indicate that m etformin treatment in pregnancy might prevent late miscarriages and preterm births. Metformin is cheap and safe and tolerable in pregnancy. Material and methods Inclusion criterai: 1) Diagnosis of PCOS, 2) age: 18-45 year old 3) singleton pregnancies be fore gestational week 13. We plan to include 1000 PCOS women in 7-10 centers, in the Nordic countries. The participants will be randomized double blindly to 1000 mg metformin twice daily or placebo, from inclusion to delivery.They will also receive diet a nd lifestyle information. Five visits from the first trimester and till delivery are planned. We will register weight, height, blood pressure, perform ultrasound examinations and draw blood samples and collect placentas. Two oral glucose tolerance tests ( OGTTs) will be performed. Information about the deliveries and offsprings will be collected from the patients files. We plan to follow up of the offsprings until young adult age to establish the long term safety of intrauterine metformin exposure ( this i s described in the protocol). The PregMet 2 study is unique in design, size and originality. Preterm birth is a major conrtibutor to childhood mortality and morbidity. Metformin is the closest treatment ever to have shown a potential to prevent preterm b irth. All this considered, we feel it would be unethical not to perform this study.

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering