Guidelines for case classification for the national birth defects prevention study

Rasmussen, Sonja A.; Olney, Richard S.; Holmes, Lewis B.; Lin, Angela E.; Keppler‐Noreuil, Kim M.; Moore, Cynthia A.

doi:10.1002/bdra.10012

Cited by 532 publications

(586 citation statements)

References 49 publications

(50 reference statements)

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“…Congenital malformations were classified as major or minor by two experts according to established standards (21)(22)(23). Major birth defects were defined as structural abnormalities of medical, surgical, or cosmetic relevance.…”

Section: Methodsmentioning

confidence: 99%

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Padberg

Wacker

Meister

et al. 2014

Antimicrob Agents Chemother

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bFluoroquinolones are avoided during pregnancy due to developmental toxicity in animals. The aim of this study was to assess the fetal risk after intrauterine fluoroquinolone exposure. We performed an observational study of a prospectively ascertained cohort of pregnant women exposed to a fluoroquinolone during the first trimester. Pregnancy outcomes were compared to those of a cohort exposed to neither fluoroquinolones nor teratogenic or fetotoxic drugs. The outcomes evaluated were major birth defects (structural abnormalities of medical, surgical, or cosmetic relevance), spontaneous abortion, and elective termination of pregnancy. Pregnancy outcomes of 949 women with fluoroquinolone treatment were compared with those of 3,796 nonexposed controls. Neither the rate of major birth defects (2.4%; adjusted odds ratio [OR adj ], 0.91; 95% confidence interval [CI], 0.6 to 1.5) nor the risk of spontaneous abortion (adjusted hazard ratio [HR adj ], 1.01; 95% CI, 0.8 to 1.3) was increased. However, there was a nonsignificant increase in major birth defects after exposure to moxifloxacin (6/93, 6.5%; crude odds ratio [OR crude ], 2.40; 95% CI, 0.8 to 5.6). Neither a critical exposure time window within the first trimester nor a specific pattern of birth defects was demonstrated for any of the fluoroquinolones. The rate of electively terminated pregnancies was increased among the fluoroquinolone-exposed women (HR adj , 1.32; 95% CI, 1.03 to 1.7). The gestational ages at delivery and birth weights did not differ between groups. Our study did not detect an increased risk of spontaneous abortion or major birth defects. These reassuring findings support the recommendation to allow fluoroquinolone use in early pregnancy in selected cases. After the use of moxifloxacin, a detailed fetal ultrasound examination should be considered.

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Section: Methodsmentioning

confidence: 99%

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Padberg

Wacker

Meister

et al. 2014

Antimicrob Agents Chemother

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“…We used the definitions of major and minor congenital malformations developed by the Metropolitan Atlanta Congenital Defects Program of the Centers for Disease Control and Prevention (CDC) (29)(30)(31). Chromosomal diseases were excluded.…”

Section: Methodsmentioning

confidence: 99%

Fetal Safety of Macrolides

Dinur

Koren

Matok

et al. 2013

Antimicrob Agents Chemother

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Macrolide antibiotics are largely used in pregnancy for different bacterial infections. Their fetal safety has been studied by several groups, yielding opposing results. In particular, there have been studies claiming an association between macrolides and cardiovascular malformations. Exposure in early infancy has been associated with pyloric stenosis and intussusception. This has led to an avoidance in prescribing macrolides to pregnant women in several Scandinavian countries. The Objectives of the present study was to investigate the fetal safety of this class of drug by linking a large administrative database of drug dispensing and pregnancy outcome in Southern Israel. A computerized database of medications dispensed from 1999 to 2009 to all women registered in the Clalit health maintenance organization in southern Israel was linked with two computerized databases containing maternal and infant hospitalization records. Also, medical pregnancy termination data were analyzed. The following confounders were controlled for: maternal age, ethnicity, maternal pregestational diabetes, parity, and the year the mother gave birth or went through medical pregnancy termination. First-and third-trimester exposures to macrolide antibiotics as a group and to individual drugs were analyzed. During the study period there were 105,492 pregnancies among Clalit women that met the inclusion criteria. Of these, 104,380 ended in live births or dead fetuses and 1,112 in abortion due to medical reasons. In the first trimester of pregnancy, 1,033 women were exposed to macrolides. There was no association between macrolides and either major malformations [odds ratio (OR), 1.08; 95% confidence interval (CI), 0.84 to 1.38)] or specific malformations, after accounting for maternal age, parity, ethnicity, prepregnancy diabetes, and year of exposure. During the third trimester of pregnancy, 959 women were exposed to macrolides. There was no association between such exposure and perinatal mortality, low birth weight, low Apgar score, or preterm delivery. Similarly, no associations were demonstrated with pyloric stenosis or intussusception. Use of macrolides in the first trimester of pregnancy is not associated with an increased risk of major malformations. Exposure in the third trimester is not likely to increase neonatal risks for pyloric stenosis or intussusception in a clinically meaningful manner.

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“…Certain malformations, such as pulmonary hypoplasia, intestinal malrotation, gastric volvulus, and patent ductus arteriosus were considered part of a diaphragm defect sequence and were not tabulated as separate malformations [Fauza and Wilson, 1994]. Importance of precise case classification [Holmes et al, 1976;Rasmussen et al, 2003] has been stressed by others and accordingly, we classified infants with CDH in two ways, by phenotype and by likely etiology (Fig. 2).…”

Section: Methodsmentioning

confidence: 99%

Infants with Bochdalek diaphragmatic hernia: Sibling precurrence and monozygotic twin discordance in a hospital‐based malformation surveillance program

Pober

Lin

Russell

et al. 2005

American J of Med Genetics Pt A

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100

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Congenital diaphragmatic hernia (CDH) is a common and often devastating birth defect. In order to learn more about possible genetic causes, we reviewed and classified 203 cases of the Bochdalek hernia type identified through the Brigham and Women's Hospital (BWH) Active Malformation Surveillance Program over a 28-year period. Phenotypically, 55% of the cases had isolated CDH, and 45% had complex CDH defined as CDH in association with additional major malformations or as part of a syndrome. When classified according to likely etiology, 17% had a Recognized Genetic etiology for their CDH, while the remaining 83% had No Apparent Genetic etiology. Detailed analysis using this largest cohort of consecutively collected cases of CDH showed low precurrence among siblings. Additionally, there was no concordance for CDH among five monozygotic twin pairs. These findings, in conjunction with previous reports of de novo dominant mutations in patients with CDH, suggest that new mutations may be an important mechanism responsible for CDH. The twin data also raise the possibility that epigenetic abnormalities contribute to the development of CDH.

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Guidelines for case classification for the national birth defects prevention study

Cited by 532 publications

References 49 publications

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Observational Cohort Study of Pregnancy Outcome after First-Trimester Exposure to Fluoroquinolones

Fetal Safety of Macrolides

Infants with Bochdalek diaphragmatic hernia: Sibling precurrence and monozygotic twin discordance in a hospital‐based malformation surveillance program

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