A Nordic multicenter study
PCOS women, in the first trimester of pregnancy (<12 weeks) have the opportunity to participate in a study in Norway, Sweden and Iceland.
A unique opportunity for the best support in pregnancy.
Physicians and midwives participating in this research study has high competence within pregnant women with PCOS, and participants will receive closer follow up than they else would in regular pregnancy care.
Trondheim, St. Olavs Hospital
Tone Shetelig Løvvik
Bergen, Haukeland Universitetssjukhus
Svein Magne Skulstad
Skien, Sykehuset Telemark
Lena Aarrestad Berg
Ålesund, Sykehuset Ålesund
Tønsberg, Sykehuset Vestfold
Britt Mari Korneliussen
Drammen, Vest Viken sykehus
Kristin Voss Hestvold
Uppsala, Uppsala Universitetsjukhus
Stockholm, Karolinska Universitetsjukhus
Marie Bixo, Professor
Örebro, Universitetsjukhuset Örebro
Gunolla Frisk Ek
Reykjavik, Landspitali Islands
The PregMet2 study
The purpose of this study is to investigate if metformin prevents late miscarriage and preterm delivery in women with polycystic ovary syndrome (PCOS). We also want to find out as much as possible about pregnancy and pregnancy complications in PCOS women. We plan to follow up children of the women who participate in the study. This research project is initiated by the Faculty of Medicine at the Norwegian University of Science and Technology.
From Norwegian and international studies, we learn that PCOS women may have difficulties to become pregnant and have an increased incidence of various pregnancy complications. Many previous studies of pregnant PCOS women have weaknesses that make it difficult to draw reliable conclusions.
Between 2005-2009, 273 pregnant PCOS women from 10 Norwegian hospitals participated in a similar study. Half of the participants received metformin and half received placebo(fake drug).
We found that:
- Metformin was well tolerated during pregnancy.
- The incidence of pregnancy induced diabetes was high among the participants (about 25%).
- There was no evidence of adverse effects of metformin in the mothers or the babies.
- We found no convincing difference in the incidence of pregnancy complications between the metformin and placebo groups.
- There was a tendency towards fewer late miscarriages and preterm deliveries in the metformin group. This was not statistically significant, and may be due to too few participants.
These may be promising results. But before routine use of metformin can be considered for pregnant PCOS women, these results have to be proved in a large study. We have calculated that a study of 1000 pregnant PCOS women is necessary.
- is a drug that has been used to treat type 2 diabetes for more than 50 years.
- does not induce "too low" levels of glucose such as insulin can do.
- is approved for use in pregnancy in the present study, but not for general use in pregnancy.
- may inhibit the absorption of folic acid and vitamin B12 from the intestines. Therefore, supplementation of these vitamins should be used during the study.
Participation in the study implies that
As a participant you follow a programme which is the same either you receive metformin or placebo (fake drug).
- you will receive written and verbal diet and lifestyle counselling.
you will receive either metformin or "placebo." Neither you nor the healthcare professionals performing the study will know what you receive, before the study is completed and all data is collected.
you follow the regular health checks as recommended for pregnant women in your country.
you will have 5 of these appointments at the maternity clinic of the study site.
you allow ultrasound examination at inclusion, week 19, week 28 and week 32.
We will perform an oral glucose tolerance test at inclusion and at week 28. This is done to detect possible diabetes in pregnancy.
Blood samples are drawn at inclusion, week 19, 28, 32 and 36. We aim to perform analysis that are relevant to various conditions and diseases during pregnancy.
We also want to take small tissue samples from the placenta and blood from the umbilical cord after the baby is born and the umbilical cord is detached.
Possible benefits of participating in the study are that participants receive a comprehensive, structured pregnancy follow-up, specially designed for women with PCOS. The doctors and midwives who are involved in the study have particular interest in and knowledge about PCOS.
Possible disadvantages are that you have to spend some more time on participation in the study compared to regular check-ups. For all appointments you should attend fasting. Some might experience the drawing of blood samples a bit uncomfortable
In case of normal liver and renal function (this is a prerequisite for participation) metformin carry no risk of serious side effects. Harmless, usually temporary side effects may be nausea, diarrhoea, mild abdominal discomfort and metallic taste in the mouth. The slow increase of metformin dosage and intake combined with food reduces these effects. Metformin has never been reported to have teratogenic effect(damage/harm to the foetus).
Study participation is voluntary. You may at any time-point, without giving any reason, withdraw from the study. This will have no negative consequences for you.
If you withdraw from the study, you will return to your general practitioner/midwife and will be followed up in accordance with the procedures in your home municipality.
St. Olavs Hospital is the main hospital in the study and started including 19.10.12.
All Study centres are now including participants in the study, advertising takes place both on Facebook, Google and Twitter.
You're welcome to contact us!