Association between oral intake of dydrogesterone during early pregnancy and congenital heart disease: a case-control study
Congenital heart disease is the most frequent form of congenital anomaly in newborn infants and accounts for more than a quarter of all serious congenital abnormalities worldwide. A genetic cause is identified in less than 20% of cases of congenital heart disease and in most cases the cause remains...
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Veröffentlicht in: | The Lancet (British edition) 2017-08, Vol.390, p.S8-S8 |
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description | Congenital heart disease is the most frequent form of congenital anomaly in newborn infants and accounts for more than a quarter of all serious congenital abnormalities worldwide. A genetic cause is identified in less than 20% of cases of congenital heart disease and in most cases the cause remains unknown. In the context of the health burden of congenital heart disease, the contribution of non-inherited risk factors is important, especially if the disease is caused by a drug that can be avoided during pregnancy. We sought to determine whether maternal dydrogesterone treatment in early pregnancy is associated with congenital heart disease in the infant.
A retrospective case-control study of birth defects and associated risk factors was conducted at Al Rantisi Specialist Paediatric Hospital in the Gaza Strip. Data were obtained and compared between 202 children born with congenital heart disease and a control group of 200 childrenwho did not have congenital heart disease and were randomly selected from the same geographical populations during their admission due to different medical reasons. All children were born in the period of 2010–2013. Data were collected from June, 2013, to December, 2013, by interview with mothers. Dydrogesterone exposure was defined as any reported use during the first trimester of pregnancy. Exclusion criteria included stillbirth, chromosomal abnormalities in the child, and maternal chronic medical illnesses such as diabetes. Binary logistic regression analyses were used to identify any association between drug exposure and congenital heart disease. The study was approved by the human research ethics committee, Ministry of Health, Gaza Strip. Verbal informed consent was obtained from the children's parents.
Exposure to dydrogesterone during the first trimester of pregnancy was more frequent among mothers of children born with congenital heart disease (75 of 202) than in mothers of children in the control group (36 of 200; adjusted odds ratio 2·71, 95% CI 1·54–4·24, p |
doi_str_mv | 10.1016/S0140-6736(17)32059-7 |
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A retrospective case-control study of birth defects and associated risk factors was conducted at Al Rantisi Specialist Paediatric Hospital in the Gaza Strip. Data were obtained and compared between 202 children born with congenital heart disease and a control group of 200 childrenwho did not have congenital heart disease and were randomly selected from the same geographical populations during their admission due to different medical reasons. All children were born in the period of 2010–2013. Data were collected from June, 2013, to December, 2013, by interview with mothers. Dydrogesterone exposure was defined as any reported use during the first trimester of pregnancy. Exclusion criteria included stillbirth, chromosomal abnormalities in the child, and maternal chronic medical illnesses such as diabetes. Binary logistic regression analyses were used to identify any association between drug exposure and congenital heart disease. The study was approved by the human research ethics committee, Ministry of Health, Gaza Strip. Verbal informed consent was obtained from the children's parents.
Exposure to dydrogesterone during the first trimester of pregnancy was more frequent among mothers of children born with congenital heart disease (75 of 202) than in mothers of children in the control group (36 of 200; adjusted odds ratio 2·71, 95% CI 1·54–4·24, p<0.001].
We identified a positive association between dydrogesterone use during early pregnancy and congenital heart disease in the offspring. Further studies are needed to confirm these findings.
None.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(17)32059-7</identifier><language>eng</language><publisher>London: Elsevier Ltd</publisher><subject>Abnormalities ; Birth defects ; Cardiovascular disease ; Cardiovascular diseases ; Case studies ; Children ; Chromosome aberrations ; Congenital defects ; Control methods ; Coronary artery disease ; Diabetes mellitus ; Disease control ; Ethics ; Exposure ; Heart ; Heart diseases ; Illnesses ; Infants ; Informed consent ; Offspring ; Parents ; Pediatrics ; Pregnancy ; Regression analysis ; Research ethics ; Risk analysis ; Risk factors</subject><ispartof>The Lancet (British edition), 2017-08, Vol.390, p.S8-S8</ispartof><rights>2017 Elsevier Ltd</rights><rights>Copyright Elsevier Limited Aug 1, 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2817-d674ab12ef53e9139980fcaf449149070c104304d4c80a65210d74a5a4c9a143</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1925902680?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64389,72469</link.rule.ids></links><search><creatorcontrib>Zaqout, Mahmoud</creatorcontrib><creatorcontrib>Aslem, Emad</creatorcontrib><creatorcontrib>Abuqamar, Mazen</creatorcontrib><creatorcontrib>Abughazza, Osama</creatorcontrib><creatorcontrib>Panzer, Joseph</creatorcontrib><creatorcontrib>Wolf, Daniel De</creatorcontrib><title>Association between oral intake of dydrogesterone during early pregnancy and congenital heart disease: a case-control study</title><title>The Lancet (British edition)</title><description>Congenital heart disease is the most frequent form of congenital anomaly in newborn infants and accounts for more than a quarter of all serious congenital abnormalities worldwide. A genetic cause is identified in less than 20% of cases of congenital heart disease and in most cases the cause remains unknown. In the context of the health burden of congenital heart disease, the contribution of non-inherited risk factors is important, especially if the disease is caused by a drug that can be avoided during pregnancy. We sought to determine whether maternal dydrogesterone treatment in early pregnancy is associated with congenital heart disease in the infant.
A retrospective case-control study of birth defects and associated risk factors was conducted at Al Rantisi Specialist Paediatric Hospital in the Gaza Strip. Data were obtained and compared between 202 children born with congenital heart disease and a control group of 200 childrenwho did not have congenital heart disease and were randomly selected from the same geographical populations during their admission due to different medical reasons. All children were born in the period of 2010–2013. Data were collected from June, 2013, to December, 2013, by interview with mothers. Dydrogesterone exposure was defined as any reported use during the first trimester of pregnancy. Exclusion criteria included stillbirth, chromosomal abnormalities in the child, and maternal chronic medical illnesses such as diabetes. Binary logistic regression analyses were used to identify any association between drug exposure and congenital heart disease. The study was approved by the human research ethics committee, Ministry of Health, Gaza Strip. Verbal informed consent was obtained from the children's parents.
Exposure to dydrogesterone during the first trimester of pregnancy was more frequent among mothers of children born with congenital heart disease (75 of 202) than in mothers of children in the control group (36 of 200; adjusted odds ratio 2·71, 95% CI 1·54–4·24, p<0.001].
We identified a positive association between dydrogesterone use during early pregnancy and congenital heart disease in the offspring. Further studies are needed to confirm these findings.
None.</description><subject>Abnormalities</subject><subject>Birth defects</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Case studies</subject><subject>Children</subject><subject>Chromosome aberrations</subject><subject>Congenital defects</subject><subject>Control methods</subject><subject>Coronary artery disease</subject><subject>Diabetes mellitus</subject><subject>Disease control</subject><subject>Ethics</subject><subject>Exposure</subject><subject>Heart</subject><subject>Heart diseases</subject><subject>Illnesses</subject><subject>Infants</subject><subject>Informed consent</subject><subject>Offspring</subject><subject>Parents</subject><subject>Pediatrics</subject><subject>Pregnancy</subject><subject>Regression analysis</subject><subject>Research ethics</subject><subject>Risk analysis</subject><subject>Risk 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case-control study</atitle><jtitle>The Lancet (British edition)</jtitle><date>2017-08</date><risdate>2017</risdate><volume>390</volume><spage>S8</spage><epage>S8</epage><pages>S8-S8</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><abstract>Congenital heart disease is the most frequent form of congenital anomaly in newborn infants and accounts for more than a quarter of all serious congenital abnormalities worldwide. A genetic cause is identified in less than 20% of cases of congenital heart disease and in most cases the cause remains unknown. In the context of the health burden of congenital heart disease, the contribution of non-inherited risk factors is important, especially if the disease is caused by a drug that can be avoided during pregnancy. We sought to determine whether maternal dydrogesterone treatment in early pregnancy is associated with congenital heart disease in the infant.
A retrospective case-control study of birth defects and associated risk factors was conducted at Al Rantisi Specialist Paediatric Hospital in the Gaza Strip. Data were obtained and compared between 202 children born with congenital heart disease and a control group of 200 childrenwho did not have congenital heart disease and were randomly selected from the same geographical populations during their admission due to different medical reasons. All children were born in the period of 2010–2013. Data were collected from June, 2013, to December, 2013, by interview with mothers. Dydrogesterone exposure was defined as any reported use during the first trimester of pregnancy. Exclusion criteria included stillbirth, chromosomal abnormalities in the child, and maternal chronic medical illnesses such as diabetes. Binary logistic regression analyses were used to identify any association between drug exposure and congenital heart disease. The study was approved by the human research ethics committee, Ministry of Health, Gaza Strip. Verbal informed consent was obtained from the children's parents.
Exposure to dydrogesterone during the first trimester of pregnancy was more frequent among mothers of children born with congenital heart disease (75 of 202) than in mothers of children in the control group (36 of 200; adjusted odds ratio 2·71, 95% CI 1·54–4·24, p<0.001].
We identified a positive association between dydrogesterone use during early pregnancy and congenital heart disease in the offspring. Further studies are needed to confirm these findings.
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subjects | Abnormalities Birth defects Cardiovascular disease Cardiovascular diseases Case studies Children Chromosome aberrations Congenital defects Control methods Coronary artery disease Diabetes mellitus Disease control Ethics Exposure Heart Heart diseases Illnesses Infants Informed consent Offspring Parents Pediatrics Pregnancy Regression analysis Research ethics Risk analysis Risk factors |
title | Association between oral intake of dydrogesterone during early pregnancy and congenital heart disease: a case-control study |
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