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The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta‐analysis
Background Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole. Objectives To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimeste...
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| Published in: | BJOG : an international journal of obstetrics and gynaecology 2019-12, Vol.126 (13), p.1546-1552 |
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| container_end_page | 1552 |
| container_issue | 13 |
| container_start_page | 1546 |
| container_title | BJOG : an international journal of obstetrics and gynaecology |
| container_volume | 126 |
| creator | Zhang, Z Zhang, X Zhou, Y‐y Jiang, C‐m Jiang, H‐y |
| description | Background
Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole.
Objectives
To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimester of pregnancy.
Search strategy
A systematic literature search was conducted to identify relevant studies published from inception until April 2019.
Selection criteria
Relevant English‐language citations using the terms oral fluconazole and pregnancy in humans.
Data collection
Two reviewers independently ed data and assessed study quality.
Main results
Oral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations (odds ratio [OR] 1.09, 95% CI 0.99–1.2, P = 0.088; n = 6 studies), whereas in the subgroup analysis, this association existed only for high‐dose users (>150 mg) (OR 1. 19, 95% CI 1.01–1.4, P = 0.039; n = 2). Exposure to fluconazole also increased the risk of heart malformations (OR 1.31, 95% CI 1.09–1.57, P = 0.003; n = 4), cardiac septal defects (OR 1.3, 95% CI 1.1–1.67, P = 0.047; n = 3), and tetralogy of Fallot (OR 3.39 95% CI 1.71–6.74, P |
| doi_str_mv | 10.1111/1471-0528.15913 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2312074072</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2312074072</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3713-d04b9e4849573852f88d97566ed04fb037c6fc1ca77a315bd315ea06d1c448f93</originalsourceid><addsrcrecordid>eNqFkE9PwyAYh4nRuDk9ezMknrtBoaX1pot_s2SXeSaUwuzSlQmtSz35EfyMfhLpOneVA5CX5_3l5QHgEqMx9muCKcMBisJkjKMUkyMwPFSOd3cUIBImA3Dm3AohHIeInIIBwZTGMWNDYBZvCjqhVd1Co6GxooS6bKSpxKcpFcwbW1RLWHtKF9bVsLbFWrla2Q7fWLWsRCXbGyiga315LepCQqs-CrWFosrhWtXi5-tbVKJsXeHOwYkWpVMX-3MEXh_uF9OnYDZ_fJ7ezgJJGCZBjmiWKprQNGIkiUKdJHnKojhW_kVniDAZa4mlYEwQHGW535RAcY4lpYlOyQhc97kba94bPzBfmcb6IRwPCQ4Ro4iFnpr0lLTGOas03_jvCdtyjHgnmHc6eaeT7wT7jqt9bpOtVX7g_4x6IOqBbVGq9r88fvcy74N_AbOyhmY</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2312074072</pqid></control><display><type>article</type><title>The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta‐analysis</title><source>Wiley-Blackwell Read & Publish Collection</source><creator>Zhang, Z ; Zhang, X ; Zhou, Y‐y ; Jiang, C‐m ; Jiang, H‐y</creator><creatorcontrib>Zhang, Z ; Zhang, X ; Zhou, Y‐y ; Jiang, C‐m ; Jiang, H‐y</creatorcontrib><description>Background
Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole.
Objectives
To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimester of pregnancy.
Search strategy
A systematic literature search was conducted to identify relevant studies published from inception until April 2019.
Selection criteria
Relevant English‐language citations using the terms oral fluconazole and pregnancy in humans.
Data collection
Two reviewers independently ed data and assessed study quality.
Main results
Oral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations (odds ratio [OR] 1.09, 95% CI 0.99–1.2, P = 0.088; n = 6 studies), whereas in the subgroup analysis, this association existed only for high‐dose users (>150 mg) (OR 1. 19, 95% CI 1.01–1.4, P = 0.039; n = 2). Exposure to fluconazole also increased the risk of heart malformations (OR 1.31, 95% CI 1.09–1.57, P = 0.003; n = 4), cardiac septal defects (OR 1.3, 95% CI 1.1–1.67, P = 0.047; n = 3), and tetralogy of Fallot (OR 3.39 95% CI 1.71–6.74, P < 0.001; n = 2) in the offspring. In addition, exposure to fluconazole was significantly associated with an increased risk of spontaneous abortion (OR 1.99, 95% CI 1.38–2.88, P < 0.001; n = 3).
Conclusions
Oral fluconazole use during the first trimester of pregnancy appears to be associated with heart malformations and spontaneous abortion, but a causal link cannot be proven.
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Oral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.
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Oral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.</description><identifier>ISSN: 1470-0328</identifier><identifier>EISSN: 1471-0528</identifier><identifier>DOI: 10.1111/1471-0528.15913</identifier><identifier>PMID: 31446677</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Abnormalities, Drug-Induced ; Administration, Oral ; Antifungal ; Antifungal agents ; Antifungal Agents - administration & dosage ; Antifungal Agents - adverse effects ; Candidiasis ; Candidiasis, Vulvovaginal - drug therapy ; Congenital defects ; Craniofacial Abnormalities - chemically induced ; Evidence-based medicine ; Female ; Fluconazole ; Fluconazole - administration & dosage ; Fluconazole - adverse effects ; Health risk assessment ; Humans ; maternal ; Meta-analysis ; Miscarriage ; neonatal ; Newborn babies ; Patient Safety ; Pregnancy ; Pregnancy Trimester, First ; prenatal ; Systematic review ; Tetralogy of Fallot</subject><ispartof>BJOG : an international journal of obstetrics and gynaecology, 2019-12, Vol.126 (13), p.1546-1552</ispartof><rights>2019 Royal College of Obstetricians and Gynaecologists</rights><rights>2019 Royal College of Obstetricians and Gynaecologists.</rights><rights>Copyright © 2019 Royal College of Obstetricians and Gynaecologists</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3713-d04b9e4849573852f88d97566ed04fb037c6fc1ca77a315bd315ea06d1c448f93</citedby><cites>FETCH-LOGICAL-c3713-d04b9e4849573852f88d97566ed04fb037c6fc1ca77a315bd315ea06d1c448f93</cites><orcidid>0000-0001-7601-7827</orcidid></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/31446677$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Z</creatorcontrib><creatorcontrib>Zhang, X</creatorcontrib><creatorcontrib>Zhou, Y‐y</creatorcontrib><creatorcontrib>Jiang, C‐m</creatorcontrib><creatorcontrib>Jiang, H‐y</creatorcontrib><title>The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta‐analysis</title><title>BJOG : an international journal of obstetrics and gynaecology</title><addtitle>BJOG</addtitle><description>Background
Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole.
Objectives
To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimester of pregnancy.
Search strategy
A systematic literature search was conducted to identify relevant studies published from inception until April 2019.
Selection criteria
Relevant English‐language citations using the terms oral fluconazole and pregnancy in humans.
Data collection
Two reviewers independently ed data and assessed study quality.
Main results
Oral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations (odds ratio [OR] 1.09, 95% CI 0.99–1.2, P = 0.088; n = 6 studies), whereas in the subgroup analysis, this association existed only for high‐dose users (>150 mg) (OR 1. 19, 95% CI 1.01–1.4, P = 0.039; n = 2). Exposure to fluconazole also increased the risk of heart malformations (OR 1.31, 95% CI 1.09–1.57, P = 0.003; n = 4), cardiac septal defects (OR 1.3, 95% CI 1.1–1.67, P = 0.047; n = 3), and tetralogy of Fallot (OR 3.39 95% CI 1.71–6.74, P < 0.001; n = 2) in the offspring. In addition, exposure to fluconazole was significantly associated with an increased risk of spontaneous abortion (OR 1.99, 95% CI 1.38–2.88, P < 0.001; n = 3).
Conclusions
Oral fluconazole use during the first trimester of pregnancy appears to be associated with heart malformations and spontaneous abortion, but a causal link cannot be proven.
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Oral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.
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Oral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.</description><subject>Abnormalities, Drug-Induced</subject><subject>Administration, Oral</subject><subject>Antifungal</subject><subject>Antifungal agents</subject><subject>Antifungal Agents - administration & dosage</subject><subject>Antifungal Agents - adverse effects</subject><subject>Candidiasis</subject><subject>Candidiasis, Vulvovaginal - drug therapy</subject><subject>Congenital defects</subject><subject>Craniofacial Abnormalities - chemically induced</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Fluconazole</subject><subject>Fluconazole - administration & dosage</subject><subject>Fluconazole - adverse effects</subject><subject>Health risk assessment</subject><subject>Humans</subject><subject>maternal</subject><subject>Meta-analysis</subject><subject>Miscarriage</subject><subject>neonatal</subject><subject>Newborn babies</subject><subject>Patient Safety</subject><subject>Pregnancy</subject><subject>Pregnancy Trimester, First</subject><subject>prenatal</subject><subject>Systematic review</subject><subject>Tetralogy of Fallot</subject><issn>1470-0328</issn><issn>1471-0528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNqFkE9PwyAYh4nRuDk9ezMknrtBoaX1pot_s2SXeSaUwuzSlQmtSz35EfyMfhLpOneVA5CX5_3l5QHgEqMx9muCKcMBisJkjKMUkyMwPFSOd3cUIBImA3Dm3AohHIeInIIBwZTGMWNDYBZvCjqhVd1Co6GxooS6bKSpxKcpFcwbW1RLWHtKF9bVsLbFWrla2Q7fWLWsRCXbGyiga315LepCQqs-CrWFosrhWtXi5-tbVKJsXeHOwYkWpVMX-3MEXh_uF9OnYDZ_fJ7ezgJJGCZBjmiWKprQNGIkiUKdJHnKojhW_kVniDAZa4mlYEwQHGW535RAcY4lpYlOyQhc97kba94bPzBfmcb6IRwPCQ4Ro4iFnpr0lLTGOas03_jvCdtyjHgnmHc6eaeT7wT7jqt9bpOtVX7g_4x6IOqBbVGq9r88fvcy74N_AbOyhmY</recordid><startdate>201912</startdate><enddate>201912</enddate><creator>Zhang, Z</creator><creator>Zhang, X</creator><creator>Zhou, Y‐y</creator><creator>Jiang, C‐m</creator><creator>Jiang, H‐y</creator><general>Wiley Subscription Services, 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>7QP</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope><scope>K9.</scope><orcidid>https://orcid.org/0000-0001-7601-7827</orcidid></search><sort><creationdate>201912</creationdate><title>The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta‐analysis</title><author>Zhang, Z ; Zhang, X ; Zhou, Y‐y ; Jiang, C‐m ; Jiang, H‐y</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3713-d04b9e4849573852f88d97566ed04fb037c6fc1ca77a315bd315ea06d1c448f93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Abnormalities, Drug-Induced</topic><topic>Administration, Oral</topic><topic>Antifungal</topic><topic>Antifungal agents</topic><topic>Antifungal Agents - administration & dosage</topic><topic>Antifungal Agents - adverse effects</topic><topic>Candidiasis</topic><topic>Candidiasis, Vulvovaginal - drug therapy</topic><topic>Congenital defects</topic><topic>Craniofacial Abnormalities - chemically induced</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Fluconazole</topic><topic>Fluconazole - administration & dosage</topic><topic>Fluconazole - adverse effects</topic><topic>Health risk assessment</topic><topic>Humans</topic><topic>maternal</topic><topic>Meta-analysis</topic><topic>Miscarriage</topic><topic>neonatal</topic><topic>Newborn babies</topic><topic>Patient Safety</topic><topic>Pregnancy</topic><topic>Pregnancy Trimester, First</topic><topic>prenatal</topic><topic>Systematic review</topic><topic>Tetralogy of Fallot</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Z</creatorcontrib><creatorcontrib>Zhang, X</creatorcontrib><creatorcontrib>Zhou, Y‐y</creatorcontrib><creatorcontrib>Jiang, C‐m</creatorcontrib><creatorcontrib>Jiang, H‐y</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Z</au><au>Zhang, X</au><au>Zhou, Y‐y</au><au>Jiang, C‐m</au><au>Jiang, H‐y</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta‐analysis</atitle><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle><addtitle>BJOG</addtitle><date>2019-12</date><risdate>2019</risdate><volume>126</volume><issue>13</issue><spage>1546</spage><epage>1552</epage><pages>1546-1552</pages><issn>1470-0328</issn><eissn>1471-0528</eissn><abstract>Background
Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole.
Objectives
To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimester of pregnancy.
Search strategy
A systematic literature search was conducted to identify relevant studies published from inception until April 2019.
Selection criteria
Relevant English‐language citations using the terms oral fluconazole and pregnancy in humans.
Data collection
Two reviewers independently ed data and assessed study quality.
Main results
Oral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations (odds ratio [OR] 1.09, 95% CI 0.99–1.2, P = 0.088; n = 6 studies), whereas in the subgroup analysis, this association existed only for high‐dose users (>150 mg) (OR 1. 19, 95% CI 1.01–1.4, P = 0.039; n = 2). Exposure to fluconazole also increased the risk of heart malformations (OR 1.31, 95% CI 1.09–1.57, P = 0.003; n = 4), cardiac septal defects (OR 1.3, 95% CI 1.1–1.67, P = 0.047; n = 3), and tetralogy of Fallot (OR 3.39 95% CI 1.71–6.74, P < 0.001; n = 2) in the offspring. In addition, exposure to fluconazole was significantly associated with an increased risk of spontaneous abortion (OR 1.99, 95% CI 1.38–2.88, P < 0.001; n = 3).
Conclusions
Oral fluconazole use during the first trimester of pregnancy appears to be associated with heart malformations and spontaneous abortion, but a causal link cannot be proven.
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Oral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.
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Oral fluconazole during the first trimester of pregnancy may be associated with unfavourable pregnancy outcomes.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31446677</pmid><doi>10.1111/1471-0528.15913</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-7601-7827</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-0328 |
| ispartof | BJOG : an international journal of obstetrics and gynaecology, 2019-12, Vol.126 (13), p.1546-1552 |
| issn | 1470-0328 1471-0528 |
| language | eng |
| recordid | cdi_proquest_journals_2312074072 |
| source | Wiley-Blackwell Read & Publish Collection |
| subjects | Abnormalities, Drug-Induced Administration, Oral Antifungal Antifungal agents Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Candidiasis Candidiasis, Vulvovaginal - drug therapy Congenital defects Craniofacial Abnormalities - chemically induced Evidence-based medicine Female Fluconazole Fluconazole - administration & dosage Fluconazole - adverse effects Health risk assessment Humans maternal Meta-analysis Miscarriage neonatal Newborn babies Patient Safety Pregnancy Pregnancy Trimester, First prenatal Systematic review Tetralogy of Fallot |
| title | The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta‐analysis |
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