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FältnamnIndikatorerMetadata
00008056naa a2200613 4500
001oai:DiVA.org:umu-157946
003SwePub
008190418s2019 | |||||||||||000 ||eng|
009oai:DiVA.org:uu-381111
009oai:prod.swepub.kib.ki.se:140551724
024a https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-1579462 URI
024a https://doi.org/10.1016/S2213-8587(19)30002-62 DOI
024a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3811112 URI
024a http://kipublications.ki.se/Default.aspx?queryparsed=id:1405517242 URI
040 a (SwePub)umud (SwePub)uud (SwePub)ki
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a Løvvik, Tone S.u Norwegian Univ Sci & Technol, Dept Clin & Mol Med, N-7491 Trondheim, Norway;St Olavs Univ Hosp, Dept Gynaecol & Obstet, Trondheim, Norway4 aut
2451 0a Use of metformin to treat pregnant women with polycystic ovary syndrome (PregMet2) :b a randomised, double-blind, placebo-controlled trial
264 1b Elsevier,c 2019
338 a print2 rdacarrier
520 a Background: Women with polycystic ovary syndrome (PCOS) have an increased risk of pregnancy complications. Epi-analysis of two previous randomised controlled trials that compared metformin with placebo during pregnancy in women with PCOS showed a significant reduction in late miscarriages and preterm births in the metformin group. The aim of this third randomised trial (PregMet2) was to test the hypothesis that metformin prevents late miscarriage and preterm birth in women with PCOS.Methods: PregMet2 was a randomised, placebo-controlled, double-blind, multicentre trial done at 14 hospitals in Norway, Sweden, and Iceland. Singleton pregnant women with PCOS aged 18-45 years were eligible for inclusion. After receiving information about the study at their first antenatal visit or from the internet, women signed up individually to participate in the study. Participants were randomly assigned (1: 1) to receive metformin or placebo by computer-generated random numbers. Randomisation was in blocks of ten for each country and centre; the first block had a random size between one and ten to assure masking. Participants were assigned to receive oral metformin 500 mg twice daily or placebo during the first week of treatment, which increased to 1000 mg twice daily or placebo from week 2 until delivery. Placebo tablets and metformin tablets were identical and participants and study personnel were masked to treatment allocation. The primary outcome was the composite incidence of late miscarriage (between week 13 and week 22 and 6 days) and preterm birth (between week 23 and week 36 and 6 days), analysed in the intention-to-treat population. Secondary endpoints included the incidence of gestational diabetes, preeclampsia, pregnancy-induced hypertension, and admission of the neonate to the neonatal intensive care unit. We also did a post-hoc individual participant data analysis of pregnancy outcomes, pooling data from the two previous trials with the present study. The study was registered with ClinicalTrials. gov, number NCT01587378, and EudraCT, number 2011-002203-15.Findings: The study took place between Oct 19, 2012, and Sept 1, 2017. We randomly assigned 487 women to metformin (n=244) or placebo (n=243). In the intention-to-treat analysis, our composite primary outcome of late miscarriage and preterm birth occurred in 12 (5%) of 238 women in the metformin group and 23 (10%) of 240 women in the placebo group (odds ratio [OR] 0.50, 95% CI 0.22- 1.08; p = 0.08). We found no significant differences for our secondary endpoints, including incidence of gestational diabetes (60 [25%] of 238 women in the metformin group vs 57 [24%] of 240 women in the placebo group; OR 1.09, 95% CI 0.69-1.66; p=0.75). We noted no substantial between-group differences in serious adverse events in either mothers or offspring, and no serious adverse events were considered drug-related by principal investigators. In the post-hoc pooled analysis of individual participant data from the present trial and two previous trials, 18 (5%) of 397 women had late miscarriage or preterm delivery in the metformin group ]compared with 40 (10%) of 399 women in the placebo group (OR 0.43, 95% CI 0.23-0.79; p=0.004).Interpretation: In pregnant women with PCOS, metformin treatment from the late first trimester until delivery might reduce the risk of late miscarriage and preterm birth, but does not prevent gestational diabetes.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Reproduktionsmedicin och gynekologi0 (SwePub)302202 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Obstetrics, Gynaecology and Reproductive Medicine0 (SwePub)302202 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Endokrinologi och diabetes0 (SwePub)302052 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Endocrinology and Diabetes0 (SwePub)302052 hsv//eng
700a Carlsen, Sven M.u Norwegian Univ Sci & Technol, Dept Clin & Mol Med, N-7491 Trondheim, Norway;St Olavs Univ Hosp, Dept Endocrinol, Trondheim, Norway4 aut
700a Salvesen, Øyvindu Norwegian Univ Sci & Technol, Dept Publ Hlth & Nursing, Trondheim, Norway4 aut
700a Steffensen, Berglindu Univ Hosp Iceland, Dept Obstet & Gynaecol, Reykjavik, Iceland4 aut
700a Bixo, Marieu Umeå universitet,Obstetrik och gynekologi,Umea Univ, Dept Clin Sci, Umea, Sweden4 aut0 (Swepub:umu)mabi0001
700a Gomez-Real, Franciscou Haukeland Hosp, Dept Obstet & Gynaecol, Bergen, Norway;Univ Bergen, Dept Clin Sci, Bergen, Norway4 aut
700a Lennebotn, Marianneu Haukeland Hosp, Dept Obstet & Gynaecol, Bergen, Norway4 aut
700a Hestvold, Kristin, Vu Vestre Viken Hosp Trust, Womens Clin, Drammen, Norway4 aut
700a Zabielska, Renatau Vestfold Hosp Trust, Womens Clin, Tonsberg, Norway4 aut
700a Hirschberg, Angelica L.u Karolinska Institutet4 aut
700a Trouva, Anastasiau Karolinska Institutet,Uppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD),Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden4 aut
700a Thorarinsdottir, Solveigu Telemark Hosp Trust, Womens Clink, Skien, Norway4 aut
700a Hjelle, Sisselu Alesund Hosp, Womens Clin, Alesund, Norway4 aut
700a Berg, Ann Hildeu Innlandet Hosp Trust, Womens Clink, Lillehammer, Norway4 aut
700a Andrae, Fridau Nordlands Hosp Trust, Womens Clin, Bodo, Norway4 aut
700a Sundström Poromaa, Inger,d 1964-u Uppsala universitet,Reproduktiv hälsa4 aut0 (Swepub:uu)inspo702
700a Molin, Johannau Umeå universitet,Obstetrik och gynekologi,Umea Univ, Dept Clin Sci, Umea, Sweden;Sadersjukhuset, Stockholm, Sweden4 aut0 (Swepub:umu)jomo0065
700a Underdal, Mariau Norwegian Univ Sci & Technol, Dept Clin & Mol Med, N-7491 Trondheim, Norway;St Olavs Univ Hosp, Dept Gynaecol & Obstet, Trondheim, Norway4 aut
700a Vanky, Eszteru Norwegian Univ Sci & Technol, Dept Clin & Mol Med, N-7491 Trondheim, Norway;St Olavs Univ Hosp, Dept Gynaecol & Obstet, Trondheim, Norway4 aut
700a Salvesen, O4 aut
710a Norwegian Univ Sci & Technol, Dept Clin & Mol Med, N-7491 Trondheim, Norway;St Olavs Univ Hosp, Dept Gynaecol & Obstet, Trondheim, Norwayb Norwegian Univ Sci & Technol, Dept Clin & Mol Med, N-7491 Trondheim, Norway;St Olavs Univ Hosp, Dept Endocrinol, Trondheim, Norway4 org
773t The Lancet Diabetes and Endocrinologyd : Elsevierg 7:4, s. 256-266q 7:4<256-266x 2213-8587x 2213-8595
856u https://doi.org/10.1016/S2213-8587(19)30002-6y Fulltext
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-157946
8564 8u https://doi.org/10.1016/S2213-8587(19)30002-6
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-381111
8564 8u http://kipublications.ki.se/Default.aspx?queryparsed=id:140551724

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