Levetiracetam Pregnancy Registry: Final results and a review of the impact of registry methodology and definitions on the prevalence of major congenital malformations

2019 ◽  
Vol 111 (13) ◽  
pp. 872-887 ◽  
Author(s):  
Angela E. Scheuerle ◽  
Lewis B. Holmes ◽  
Jessica D. Albano ◽  
Vincent Badalamenti ◽  
Dina Battino ◽  
...  
Author(s):  
Ushma C. Mehta ◽  
Cari Van Schalkwyk ◽  
Prineetha Naidoo ◽  
Arthi Ramkissoon ◽  
Otty Mhlongo ◽  
...  

Background: In 2013, a pregnancy exposure registry and birth defects surveillance (PER/BDS) system was initiated in eThekwini District, KwaZulu-Natal (KZN), to assess the impact of antiretroviral treatment (ART) on birth outcomes.Objectives: At the end of the first year, we assessed the risk of major congenital malformations (CM) and other adverse birth outcomes (ABOs) detected at birth, in children born to women exposed to ART during pregnancy.Method: Data were collected from women who delivered at Prince Mshiyeni Memorial Hospital, Durban, from 07 October 2013 to 06 October 2014, using medicine exposure histories and birth outcomes from maternal interviews, clinical records and neonatal surface examination. Singleton births exposed to only one ART regimen were included in bivariable analysis for CM risk and multivariate risk analysis for ABO risk.Results: Data were collected from 10 417 women with 10 517 birth outcomes (4013 [38.5%] HIV-infected). Congenital malformations rates in births exposed to Efavirenz during the first trimester (T1) (RR 0.87 [95% CI 0.12–6.4; p = 0.895]) were similar to births not exposed to ART during T1. However, T1 exposure to Nevirapine was associated with the increased risk of CM (RR 9.28 [95% CI 2.3–37.9; p = 0.002]) when compared to the same group. Other ABOs were more frequent in the combination of HIV/ART-exposed births compared to HIV-unexposed births (29.9% vs. 26.0%, adjusted RR 1.23 [1.14–1.31; p 0.001]).Conclusion: No association between T1 use of EFV-based ART regimens and CM was observed. Associations between T1 NVP-based ART regimen and CM need further investigation. HIV- and ART-exposed infants had more ABOs compared to HIV-unexposed infants.


Neonatology ◽  
2021 ◽  
pp. 1-19
Author(s):  
Janine Kröger ◽  
Christian Günster ◽  
Günther Heller ◽  
Elke Jeschke ◽  
Jürgen Malzahn ◽  
...  

<b><i>Background:</i></b> Low birthweight and major congenital malformations (MCMs) are key causes of infant mortality. <b><i>Objectives:</i></b> The aim of this study was to explore the prevalence of MCMs in infants with low and very low birthweight and analyze the impact of MCMs and birthweight on infant mortality. <b><i>Methods:</i></b> We determined prevalence and infant mortality of 28 life-threatening MCMs in very-low-birthweight (&#x3c;1,500 g, VLBW), low-birthweight (1,500–2,499 g, LBW), or normal-birthweight (≥2,500 g, NBW) infants in a cohort of 2,727,002 infants born in Germany in 2006–2017, using de-identified administrative data of the largest statutory public health insurance system in Germany. <b><i>Results:</i></b> The rates of VLBW, LBW, and NBW infants studied were 1.3% (34,401), 4.0% (109,558), and 94.7% (2,583,043). MCMs affected 0.5% (13,563) infants, of whom &#x3e;75% (10,316) had severe congenital heart disease. The prevalence (per 10,000) of any/cardiac MCM was increased in VLBW (286/176) and LBW (244/143), as compared to NBW infants (38/32). Infant mortality rates were significantly higher in infants with an MCM, as opposed to infants without an MCM, in each birthweight group (VLBW 28.5% vs. 11.5%, LBW 16.7% vs. 0.9%, and NBW 8.6% vs. 0.1%). For most MCMs, observed survival rates in VLBW and LBW infants were lower than expected, as calculated from survival rates of VLBW or LBW infants without an MCM, and NBW infants with an MCM. <b><i>Conclusions:</i></b> Infants with an MCM are more often born with LBW or VLBW, as opposed to infants without an MCM. Many MCMs carry significant excess mortality when occurring in VLBW or LBW infants.


Author(s):  
Michiko Yamada ◽  
Kyoji Furukawa ◽  
Yoshimi Tatsukawa ◽  
Keiko Marumo ◽  
Sachiyo Funamoto ◽  
...  

Abstract From 1948 to 1954, the Atomic Bomb Casualty Commission conducted a study of pregnancy outcomes of children of atomic bomb survivors who had received radiation doses from zero to near-lethal levels. Past reports (1956, 1981, and 1990) on the cohort did not identify significant associations of radiation exposure with untoward pregnancy outcomes such as major congenital malformations, stillbirths, or neonatal deaths, individually or in aggregate. We have re-examined the risk of major congenital malformations and perinatal deaths in the children of the atomic bomb survivors (N=71,603) using fully reconstructed data to minimize the potential for bias, with refined estimates of the gonadal dose from the Dosimetry System 2002 and refined analytical methods for characterizing dose-response relationships. The analyses show that parental exposure is associated with increased risk for major congenital malformations and perinatal deaths, but the estimates are imprecise for direct radiation effects and most are not statistically significant. Nonetheless, the uniformly positive estimates for untoward pregnancy outcomes among children of both maternal and paternal survivors are useful for risk assessment purposes, although extending them to circumstances other than atomic bomb survivors comes with uncertainty as to the generalizability of the Hiroshima and Nagasaki populations.


PEDIATRICS ◽  
1969 ◽  
Vol 43 (1) ◽  
pp. 79-83
Author(s):  
Eric W. Fonkalsrud ◽  
Alfred A. deLorimier ◽  
Daniel M. Hays

A review is presented of 503 patients with congenital duodenal obstruction, compiled from 65 hospitals by the Surgical Section of the American Academy of Pediatrics. Four hundred eighty-seven patients underwent primary operative correction of the malformation with an overall early and late mortality rate of 36%. Complications from associated major congenital malformations were the leading cause of death. Many of these anomalies were potentially correctable had they been recognized and early treatment instituted. More than half of the infants with duodenal atresia had associated malformations. Thirty percent of the patients had Down's syndrome. End-to-side or side-to-side duodenoduodenostomy or jejunostomy are the most commonly used operative techniques for duodenal atresia. General anesthesia and tube gastrostomy are usually employed.


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