Fidelma Dunne, Christine Newman, Alberto Alvarez-Iglesias, Paula O’Shea, Declan Devane, Paddy Gillespie, Aoife Egan, Martin O’Donnell, Andrew Smyth
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We sought to identify risk factors for SGA infants, including the effect of metformin exposure on SGA status.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>In this prespecified secondary analysis of the EMERGE trial, which evaluated the effectiveness of metformin vs placebo in treating GDM and found reduced gestational weight gain and longer time to insulin initiation with metformin use, we included women with a live-born infant and known infant birthweight and gestational age at delivery. We compared the numbers of SGA infants in both groups and explored baseline predictive factors to help identify those at highest risk of delivering an SGA infant.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Baseline maternal characteristics were similar between SGA and non-SGA pregnancies. On multivariable-adjusted regression, no baseline maternal variables were associated with SGA status. Mothers of SGA infants were more likely to develop pre-eclampsia or gestational hypertension (18.2% vs 2.0%, <i>p</i>=0.001; 22.7% vs 5.4%, <i>p</i>=0.005, respectively); after multivariable adjustment, pre-eclampsia was positively associated with SGA status). Among SGA pregnancies, important perinatal outcomes including preterm birth, Caesarean delivery and neonatal care unit admission did not differ between the metformin and placebo groups (20.0% vs 14.3%, <i>p</i>=1.00; 50.0% vs 28.6%, <i>p</i>=0.25; 13.3% vs 42.9%, <i>p</i>=0.27, respectively).</p><h3 data-test=\"abstract-sub-heading\">Conclusions/interpretation</h3><p>Pre-eclampsia was strongly associated with SGA infants. Metformin-exposed SGA infants did not display a more severe SGA phenotype than infants treated with placebo.</p><h3 data-test=\"abstract-sub-heading\">Trial registration</h3><p>Clinical Trials.gov NCT02980276; EudraCT number: 2016-001644-19</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>\n","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":null,"pages":null},"PeriodicalIF":8.4000,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Metformin and small for gestational age babies: findings of a randomised placebo-controlled clinical trial of metformin in gestational diabetes (EMERGE)\",\"authors\":\"Fidelma Dunne, Christine Newman, Alberto Alvarez-Iglesias, Paula O’Shea, Declan Devane, Paddy Gillespie, Aoife Egan, Martin O’Donnell, Andrew Smyth\",\"doi\":\"10.1007/s00125-024-06252-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Aims/hypothesis</h3><p>Gestational diabetes mellitus (GDM) is associated with adverse perinatal outcomes because of suboptimal glucose management and glucose control and excessive weight gain. 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引用次数: 0
摘要
目的/假设妊娠糖尿病(GDM)与不利的围产期结局有关,因为血糖管理和血糖控制不理想以及体重增加过多。二甲双胍可以抵消这些因素,但与胎龄小婴儿(SGA)有关。我们试图确定 SGA 婴儿的风险因素,包括二甲双胍暴露对 SGA 状态的影响。在 EMERGE 试验的这项预设二次分析中,我们纳入了有活产婴儿且已知婴儿出生体重和分娩时胎龄的妇女。我们比较了两组中 SGA 婴儿的数量,并探讨了基线预测因素,以帮助确定分娩 SGA 婴儿风险最高的孕妇。在多变量调整回归中,没有任何基线母体变量与 SGA 状态相关。SGA 婴儿的母亲更有可能患先兆子痫或妊娠高血压(分别为 18.2% vs 2.0%,p=0.001;22.7% vs 5.4%,p=0.005);经多变量调整后,先兆子痫与 SGA 状态呈正相关)。在SGA妊娠中,二甲双胍组和安慰剂组的早产、剖腹产和新生儿监护室入院等重要围产期结局没有差异(分别为20.0% vs 14.3%,p=1.00;50.0% vs 28.6%,p=0.25;13.3% vs 42.9%,p=0.27)。与接受安慰剂治疗的婴儿相比,二甲双胍暴露的SGA婴儿并未表现出更严重的SGA表型。试验注册Clinical Trials.gov NCT02980276; EudraCT number: 2016-001644-19图文摘要
Metformin and small for gestational age babies: findings of a randomised placebo-controlled clinical trial of metformin in gestational diabetes (EMERGE)
Aims/hypothesis
Gestational diabetes mellitus (GDM) is associated with adverse perinatal outcomes because of suboptimal glucose management and glucose control and excessive weight gain. Metformin can offset these factors but is associated with small for gestational age (SGA) infants. We sought to identify risk factors for SGA infants, including the effect of metformin exposure on SGA status.
Methods
In this prespecified secondary analysis of the EMERGE trial, which evaluated the effectiveness of metformin vs placebo in treating GDM and found reduced gestational weight gain and longer time to insulin initiation with metformin use, we included women with a live-born infant and known infant birthweight and gestational age at delivery. We compared the numbers of SGA infants in both groups and explored baseline predictive factors to help identify those at highest risk of delivering an SGA infant.
Results
Baseline maternal characteristics were similar between SGA and non-SGA pregnancies. On multivariable-adjusted regression, no baseline maternal variables were associated with SGA status. Mothers of SGA infants were more likely to develop pre-eclampsia or gestational hypertension (18.2% vs 2.0%, p=0.001; 22.7% vs 5.4%, p=0.005, respectively); after multivariable adjustment, pre-eclampsia was positively associated with SGA status). Among SGA pregnancies, important perinatal outcomes including preterm birth, Caesarean delivery and neonatal care unit admission did not differ between the metformin and placebo groups (20.0% vs 14.3%, p=1.00; 50.0% vs 28.6%, p=0.25; 13.3% vs 42.9%, p=0.27, respectively).
Conclusions/interpretation
Pre-eclampsia was strongly associated with SGA infants. Metformin-exposed SGA infants did not display a more severe SGA phenotype than infants treated with placebo.
期刊介绍:
Diabetologia, the authoritative journal dedicated to diabetes research, holds high visibility through society membership, libraries, and social media. As the official journal of the European Association for the Study of Diabetes, it is ranked in the top quartile of the 2019 JCR Impact Factors in the Endocrinology & Metabolism category. The journal boasts dedicated and expert editorial teams committed to supporting authors throughout the peer review process.