Maternal and Neonatal Health Outcomes Associated with the Use of Gliclazide and Metformin for the Treatment of Diabetes in Pregnancy: A Record Linkage Study
Gliclazide is commonly used in the treatment of diabetes mellitus; however, very little is known regarding the safety of its use in pregnancy. The aims of this study was to examine the rate of maternal hospitalizations, congenital anomalies, and adverse neonatal outcomes in pregnant women treated wi...
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| Veröffentlicht in: | Diabetes technology & therapeutics 2020-02, Vol.22 (2), p.96-102 |
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| creator | Kelty, Erin Tran, Duong Danielle Atkinson, Andrea Preen, David B Havard, Alys |
| description | Gliclazide is commonly used in the treatment of diabetes mellitus; however, very little is known regarding the safety of its use in pregnancy. The aims of this study was to examine the rate of maternal hospitalizations, congenital anomalies, and adverse neonatal outcomes in pregnant women treated with gliclazide compared with pregnant women treated with metformin.
Women who used gliclazide during pregnancy (
= 108) between 2003 and 2012 were identified by linking national medication dispensing data with the New South Wales perinatal data collection. A comparison group of women treated with only metformin during pregnancy (
= 108) were selected using propensity score matching. Data on hospital admissions, mortality, and congenital anomalies were extracted to examine the health of mothers and their children across groups.
Rates of maternal hospitalizations during pregnancy were not significantly different between women in the two groups (incident rate ratio: 1.10, 95% CI: 0.90-1.34,
= 0.339). There was no significant difference in average birth weight (3402 g compared with 3572 g,
= 0.072), incidence of neonatal hypoglycemia ( |
| doi_str_mv | 10.1089/dia.2019.0241 |
| format | Article |
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Women who used gliclazide during pregnancy (
= 108) between 2003 and 2012 were identified by linking national medication dispensing data with the New South Wales perinatal data collection. A comparison group of women treated with only metformin during pregnancy (
= 108) were selected using propensity score matching. Data on hospital admissions, mortality, and congenital anomalies were extracted to examine the health of mothers and their children across groups.
Rates of maternal hospitalizations during pregnancy were not significantly different between women in the two groups (incident rate ratio: 1.10, 95% CI: 0.90-1.34,
= 0.339). There was no significant difference in average birth weight (3402 g compared with 3572 g,
= 0.072), incidence of neonatal hypoglycemia (<4.6% compared with <4.6%,
= 0.684), or congenital anomalies (7.4% compared with 5.6%,
= 0.582) in neonates exposed to gliclazide compared with metformin.
The use of gliclazide during pregnancy was not associated with increased maternal hospitalization or neonatal adverse outcomes in comparison with the use of metformin in pregnancy; however, the limited number of exposed pregnancies is a key limitation.</description><identifier>ISSN: 1520-9156</identifier><identifier>EISSN: 1557-8593</identifier><identifier>DOI: 10.1089/dia.2019.0241</identifier><identifier>PMID: 31621408</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Abnormalities, Drug-Induced - epidemiology ; Adult ; Antidiabetics ; Clinical outcomes ; Congenital diseases ; Diabetes ; Diabetes, Gestational - drug therapy ; Drug therapy ; Female ; Gliclazide - adverse effects ; Hospitalization - statistics & numerical data ; Humans ; Hypoglycemia - chemically induced ; Hypoglycemia - epidemiology ; Hypoglycemic Agents - adverse effects ; Incidence ; Infant, Newborn ; Infant, Newborn, Diseases - chemically induced ; Infant, Newborn, Diseases - epidemiology ; Medical Record Linkage ; Metformin - adverse effects ; New South Wales - epidemiology ; Newborn babies ; Outcome Assessment, Health Care ; Patient safety ; Pregnancy ; Pregnancy in Diabetics - drug therapy ; Pregnancy Outcome ; Womens health</subject><ispartof>Diabetes technology & therapeutics, 2020-02, Vol.22 (2), p.96-102</ispartof><rights>Copyright Mary Ann Liebert, Inc. Feb 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c321t-9c800576f500e31d2ec1be6cfb9543bf362e043cac1a887893b3a35d2b9d7a253</citedby><cites>FETCH-LOGICAL-c321t-9c800576f500e31d2ec1be6cfb9543bf362e043cac1a887893b3a35d2b9d7a253</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31621408$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kelty, Erin</creatorcontrib><creatorcontrib>Tran, Duong Danielle</creatorcontrib><creatorcontrib>Atkinson, Andrea</creatorcontrib><creatorcontrib>Preen, David B</creatorcontrib><creatorcontrib>Havard, Alys</creatorcontrib><title>Maternal and Neonatal Health Outcomes Associated with the Use of Gliclazide and Metformin for the Treatment of Diabetes in Pregnancy: A Record Linkage Study</title><title>Diabetes technology & therapeutics</title><addtitle>Diabetes Technol Ther</addtitle><description>Gliclazide is commonly used in the treatment of diabetes mellitus; however, very little is known regarding the safety of its use in pregnancy. The aims of this study was to examine the rate of maternal hospitalizations, congenital anomalies, and adverse neonatal outcomes in pregnant women treated with gliclazide compared with pregnant women treated with metformin.
Women who used gliclazide during pregnancy (
= 108) between 2003 and 2012 were identified by linking national medication dispensing data with the New South Wales perinatal data collection. A comparison group of women treated with only metformin during pregnancy (
= 108) were selected using propensity score matching. Data on hospital admissions, mortality, and congenital anomalies were extracted to examine the health of mothers and their children across groups.
Rates of maternal hospitalizations during pregnancy were not significantly different between women in the two groups (incident rate ratio: 1.10, 95% CI: 0.90-1.34,
= 0.339). There was no significant difference in average birth weight (3402 g compared with 3572 g,
= 0.072), incidence of neonatal hypoglycemia (<4.6% compared with <4.6%,
= 0.684), or congenital anomalies (7.4% compared with 5.6%,
= 0.582) in neonates exposed to gliclazide compared with metformin.
The use of gliclazide during pregnancy was not associated with increased maternal hospitalization or neonatal adverse outcomes in comparison with the use of metformin in pregnancy; however, the limited number of exposed pregnancies is a key limitation.</description><subject>Abnormalities, Drug-Induced - epidemiology</subject><subject>Adult</subject><subject>Antidiabetics</subject><subject>Clinical outcomes</subject><subject>Congenital diseases</subject><subject>Diabetes</subject><subject>Diabetes, Gestational - drug therapy</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Gliclazide - adverse effects</subject><subject>Hospitalization - statistics & numerical data</subject><subject>Humans</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - epidemiology</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Incidence</subject><subject>Infant, Newborn</subject><subject>Infant, Newborn, Diseases - chemically induced</subject><subject>Infant, Newborn, Diseases - epidemiology</subject><subject>Medical Record Linkage</subject><subject>Metformin - adverse effects</subject><subject>New South Wales - epidemiology</subject><subject>Newborn babies</subject><subject>Outcome Assessment, Health Care</subject><subject>Patient safety</subject><subject>Pregnancy</subject><subject>Pregnancy in Diabetics - drug therapy</subject><subject>Pregnancy Outcome</subject><subject>Womens health</subject><issn>1520-9156</issn><issn>1557-8593</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kUtv1TAQha0K1BddskWWWOfiR5zE7K5auEW6pYi262hiT1qXJG5tR-jyW_pjcdrC6sxoPh1pziHkPWcrzhr9yTpYCcb1iomS75FDrlRdNErLN8ssWKG5qg7IUYz3jLFaCr5PDiSvBC9Zc0ieLiBhmGCgMFn6Hf0EKS_nCEO6o5dzMn7ESNcxeuMyaulvlw_pDulNROp7uhmcGeCPs_hscYGp92F0E83yzF0HhDTilBb6zEGHKTtm4EfA2wkms_tM1_QnGh8s3brpF9wivUqz3b0jb3sYIp686jG5-frl-vS82F5uvp2ut4XJ76RCm4YxVVe9YgwltwIN77AyfadVKbteVgJZKQ0YDk1TN1p2EqSyotO2BqHkMfn44vsQ_OOMMbX3fl5Cia2QpVSN5hXPVPFCmeBjDNi3D8GNEHYtZ-3SRZu7aJcu2qWLzH94dZ27Ee1_-l_48i9zdIWX</recordid><startdate>202002</startdate><enddate>202002</enddate><creator>Kelty, Erin</creator><creator>Tran, Duong Danielle</creator><creator>Atkinson, Andrea</creator><creator>Preen, David B</creator><creator>Havard, Alys</creator><general>Mary Ann Liebert, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope></search><sort><creationdate>202002</creationdate><title>Maternal and Neonatal Health Outcomes Associated with the Use of Gliclazide and Metformin for the Treatment of Diabetes in Pregnancy: A Record Linkage Study</title><author>Kelty, Erin ; Tran, Duong Danielle ; Atkinson, Andrea ; Preen, David B ; Havard, Alys</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c321t-9c800576f500e31d2ec1be6cfb9543bf362e043cac1a887893b3a35d2b9d7a253</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Abnormalities, Drug-Induced - epidemiology</topic><topic>Adult</topic><topic>Antidiabetics</topic><topic>Clinical outcomes</topic><topic>Congenital diseases</topic><topic>Diabetes</topic><topic>Diabetes, Gestational - drug therapy</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Gliclazide - adverse effects</topic><topic>Hospitalization - statistics & numerical data</topic><topic>Humans</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - epidemiology</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Incidence</topic><topic>Infant, Newborn</topic><topic>Infant, Newborn, Diseases - chemically induced</topic><topic>Infant, Newborn, Diseases - epidemiology</topic><topic>Medical Record Linkage</topic><topic>Metformin - adverse effects</topic><topic>New South Wales - epidemiology</topic><topic>Newborn babies</topic><topic>Outcome Assessment, Health Care</topic><topic>Patient safety</topic><topic>Pregnancy</topic><topic>Pregnancy in Diabetics - drug therapy</topic><topic>Pregnancy Outcome</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kelty, Erin</creatorcontrib><creatorcontrib>Tran, Duong Danielle</creatorcontrib><creatorcontrib>Atkinson, Andrea</creatorcontrib><creatorcontrib>Preen, David B</creatorcontrib><creatorcontrib>Havard, Alys</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Diabetes technology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kelty, Erin</au><au>Tran, Duong Danielle</au><au>Atkinson, Andrea</au><au>Preen, David B</au><au>Havard, Alys</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Maternal and Neonatal Health Outcomes Associated with the Use of Gliclazide and Metformin for the Treatment of Diabetes in Pregnancy: A Record Linkage Study</atitle><jtitle>Diabetes technology & therapeutics</jtitle><addtitle>Diabetes Technol Ther</addtitle><date>2020-02</date><risdate>2020</risdate><volume>22</volume><issue>2</issue><spage>96</spage><epage>102</epage><pages>96-102</pages><issn>1520-9156</issn><eissn>1557-8593</eissn><abstract>Gliclazide is commonly used in the treatment of diabetes mellitus; however, very little is known regarding the safety of its use in pregnancy. The aims of this study was to examine the rate of maternal hospitalizations, congenital anomalies, and adverse neonatal outcomes in pregnant women treated with gliclazide compared with pregnant women treated with metformin.
Women who used gliclazide during pregnancy (
= 108) between 2003 and 2012 were identified by linking national medication dispensing data with the New South Wales perinatal data collection. A comparison group of women treated with only metformin during pregnancy (
= 108) were selected using propensity score matching. Data on hospital admissions, mortality, and congenital anomalies were extracted to examine the health of mothers and their children across groups.
Rates of maternal hospitalizations during pregnancy were not significantly different between women in the two groups (incident rate ratio: 1.10, 95% CI: 0.90-1.34,
= 0.339). There was no significant difference in average birth weight (3402 g compared with 3572 g,
= 0.072), incidence of neonatal hypoglycemia (<4.6% compared with <4.6%,
= 0.684), or congenital anomalies (7.4% compared with 5.6%,
= 0.582) in neonates exposed to gliclazide compared with metformin.
The use of gliclazide during pregnancy was not associated with increased maternal hospitalization or neonatal adverse outcomes in comparison with the use of metformin in pregnancy; however, the limited number of exposed pregnancies is a key limitation.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>31621408</pmid><doi>10.1089/dia.2019.0241</doi><tpages>7</tpages></addata></record> |
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| subjects | Abnormalities, Drug-Induced - epidemiology Adult Antidiabetics Clinical outcomes Congenital diseases Diabetes Diabetes, Gestational - drug therapy Drug therapy Female Gliclazide - adverse effects Hospitalization - statistics & numerical data Humans Hypoglycemia - chemically induced Hypoglycemia - epidemiology Hypoglycemic Agents - adverse effects Incidence Infant, Newborn Infant, Newborn, Diseases - chemically induced Infant, Newborn, Diseases - epidemiology Medical Record Linkage Metformin - adverse effects New South Wales - epidemiology Newborn babies Outcome Assessment, Health Care Patient safety Pregnancy Pregnancy in Diabetics - drug therapy Pregnancy Outcome Womens health |
| title | Maternal and Neonatal Health Outcomes Associated with the Use of Gliclazide and Metformin for the Treatment of Diabetes in Pregnancy: A Record Linkage Study |
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