Dataset Information

Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services.

ABSTRACT:

Aims

Metformin is used to treat type 2 diabetes, polycystic ovary syndrome associated infertility, and gestational diabetes. This study aims to evaluate the safety of metformin in early pregnancy.

Method

We evaluated the risk of major birth defects and pregnancy losses in a cohort of pregnant women exposed to metformin during the first trimester for different indications relative to a matched unexposed reference group.

Results

The risk of major birth defects was 5.1% (20/392) in pregnancies exposed to metformin during the first trimester and 2.1% (9/431) in the reference group [adjusted odds ratio (OR) 1.70; 95% CI 0.70-4.38]. Among metformin users, this risk was 7.8% (17/219) in patients with pre-gestational diabetes and 1.7% (3/173) in those without this diagnosis. Compared to the unexposed reference, the OR for metformin user with diabetes was 3.95 (95% CI 1.77-9.41) and for metformin with other indications it was 0.83 (95% CI 0.18-2.81). The risk of pregnancy losses (spontaneous abortions and stillbirths) was 20.8% in women on metformin during the first trimester and 10.8% in the reference group [adjusted hazard ratio (HR) 1.57; 95% CI 0.90-2.74]. The risks for women on metformin with and without pre-gestational diabetes were 24.0% and 16.8% respectively, with adjusted HR of 2.51 (95% CI 1.44-4.36) and 1.38 (95% CI 0.74-2.59) when compared to the reference.

Conclusion

Pregnant women with pre-gestational diabetes on metformin are at a higher risk for adverse pregnancy outcomes than the general population. This appears to be due to the underlying diabetes since women on metformin for other indications do not present meaningfully increased risks.

SUBMITTER: Panchaud A

PROVIDER: S-EPMC5809340 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Publications

Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services.

Panchaud Alice A Rousson Valentin V Vial Thierry T Bernard Nathalie N Baud David D Amar Emmanuelle E De Santis Marco M Pistelli Alessandra A Dautriche Anne A Beau-Salinas Frederique F Cassina Matteo M Dunstan Hannah H Passier Anneke A Kaplan Yusuf Cem YC Duman Mine Kadioglu MK Maňáková Eva E Eleftheriou Georgios G Klinger Gil G Winterfeld Ursula U Rothuizen Laura E LE Buclin Thierry T Csajka Chantal C Hernandez-Diaz Sonia S

British journal of clinical pharmacology 20180114 3

<h4>Aims</h4>Metformin is used to treat type 2 diabetes, polycystic ovary syndrome associated infertility, and gestational diabetes. This study aims to evaluate the safety of metformin in early pregnancy.<h4>Method</h4>We evaluated the risk of major birth defects and pregnancy losses in a cohort of pregnant women exposed to metformin during the first trimester for different indications relative to a matched unexposed reference group.<h4>Results</h4>The risk of major birth defects was 5.1% (20/39 ...[more]

PMID: 29215149

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Project description:The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy.The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH?<?7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants.The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population.ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009.

Project description:BackgroundInformation-seeking behaviour is necessary to improve knowledge on diabetes therapy and complications. Combined with other self-management skills and autonomous handling of the disease, it is essential for achieving treatment targets. However, a systematic review addressing this topic is lacking. The aims of this systematic review were to identify and analyse existing knowledge of information-seeking behaviour: (1) types information-seeking behaviour, (2) information sources, (3) the content of searched information, and (4) associated variables that may affect information-seeking behaviour.MethodsThe systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) requirements. MEDLINE, CINAHL, EMBASE, ScienceDirect, PsycInfo, Cochrane Library, Web of Science, CCMed, ERIC, Journals@OVID, Deutsches Ärzteblatt and Karlsruher virtueller Katalog (KvK) databases were searched. Publications dealing with information-seeking behaviour of people with diabetes mellitus published up to June 2015 were included. A forward citation tracking was performed in September 2016 and June 2017. Additionally, an update of the two main databases (MEDLINE, CINAHL) was conducted, considering studies published up to July 2017. Studies published in languages other than English or German were excluded, as well as letters, short reports, editorials, comments and discussion papers. A study selection and the critical appraisal of the selected studies were performed independently by two reviewers. A third reviewer was consulted if any disagreement was found. Data extraction and content analysis were performed using selected dimensions of Wilson's 'model of information behaviour'.ResultsTwenty-six studies were included. Five 'types of information-seeking behaviour' were identified, e.g. passive and active search. The 'Internet' and 'healthcare professionals' were the most frequently reported sources. 'Diet', 'complications', 'exercise' and 'medications and pharmacological interactions' were the most frequently identified content of information. Seven main categories including associated variables were identified, e.g. 'socioeconomic', 'duration of DM', and 'lifestyle'.ConclusionThe systematic review provides a valuable overview of available knowledge on the information-seeking behaviour of people with diabetes mellitus, although there are only a few studies. There was a high heterogeneity regarding the research question, design, methods and participants. Although the Internet is often used to seek information, health professionals still play an important role in supporting their patients' information-seeking behaviour. Specific needs of people with diabetes must be taken into consideration.Systematic review registrationPROSPERO CRD42016037312.

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Dataset Information

Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services.

Aims

Method

Results

Conclusion

Publications

Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services.

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