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Pregnancy outcomes of women exposed to laninamivir during pregnancy.

ABSTRACT: The purpose of this study is to assess pregnancy outcomes of women treated with a novel neuraminidase inhibitor, laninamivir, during pregnancy.A retrospective review of pregnancy outcomes of 112 pregnant women who were given laninamivir for treatment of influenza was performed. Possible adverse events, including miscarriages, preterm birth, foetal malformation and any neonatal morbidity requiring treatment, were assessed.Seventeen, 39, 46 and 10 women were administered a single inhaled dose of 20 or 40?mg of laninamivir at gestational week (GW) 3-11, 12-21, 22-36 and 37 or more, respectively. One (1.8%) of 56 women with laninamivir at GW <22 experienced miscarriage at GW <12. The remaining 111 women gave birth to 111 viable infants but at preterm (GW <37) in nine (8.8%) of 102 women with laninamivir at GW <37. Three (2.7%) of the 111 newborns had malformations: forefoot varus deformity, foot polydactyly and cleft lip in one each born to a mother taking laninamivir at GW 6, 17 and 21, respectively. Five neonates (4.5%) were small for gestational age. Eleven (9.9%), five (4.5%) and no neonates required phototherapy for jaundice, transient respiratory supports for respiratory distress syndrome (n?=?2) or transient tachypnoea of the newborn (n?=?3), and glucose administration for hypoglycaemia, respectively.Although this study included a small number of study women and no control women, the results suggested that maternal exposure to laninamivir did not increase the rate of adverse pregnancy and foetal outcomes.

SUBMITTER: Minakami H

PROVIDER: S-EPMC4265256 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Pregnancy outcomes of women exposed to laninamivir during pregnancy.

Minakami Hisanori H Kubo Takahiko T Nakai Akihito A Saito Shigeru S Unno Nobuya N

Pharmacoepidemiology and drug safety 20140729 10

<h4>Purpose</h4>The purpose of this study is to assess pregnancy outcomes of women treated with a novel neuraminidase inhibitor, laninamivir, during pregnancy.<h4>Methods</h4>A retrospective review of pregnancy outcomes of 112 pregnant women who were given laninamivir for treatment of influenza was performed. Possible adverse events, including miscarriages, preterm birth, foetal malformation and any neonatal morbidity requiring treatment, were assessed.<h4>Results</h4>Seventeen, 39, 46 and 10 wo ...[more]

PMID: 25074683

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Project description:ObjectiveEvidence is needed to guide organisational decision making about workplace accommodations for pregnant physicians. Our objective was to characterise the strengths and limitations of current research examining the association between physician-related occupational hazards with pregnancy, obstetrical and neonatal outcomes.DesignScoping review.Data sourcesMEDLINE/PubMed, EMBASE, CINAHL/ EBSCO, SciVerse Scopus and Web of Science/Knowledge were searched from inception to 2 April 2020. A grey literature search was performed on 5 April 2020. The references of all included articles were hand searched for additional citations.Eligibility criteriaEnglish language citations that studied employed pregnant people and any 'physician-related occupational hazards', meaning any relevant physical, infectious, chemical or psychological hazard, were included. Outcomes included any pregnancy, obstetrical or neonatal complication.Data extraction and synthesisPhysician-related occupational hazards included physician work, healthcare work, long work hours, 'demanding' work, disordered sleep, night shifts and exposure to radiation, chemotherapy, anaesthetic gases or infectious disease. Data were extracted independently in duplicate and reconciled through discussion.ResultsOf the 316 included citations, 189 were original research studies. Most were retrospective, observational and included women in any occupation rather than healthcare workers. Methods for exposure and outcome ascertainment varied across studies and most studies had a high risk of bias in data ascertainment. Most exposures and outcomes were defined categorically and results from different studies could not be combined in a meta-analysis due to heterogeneity in how these categories were defined. Overall, some data suggested that healthcare workers may have an increased risk of miscarriage compared with other employed women. Long work hours may be associated with miscarriage and preterm birth.ConclusionsThere are important limitations in the current evidence examining physician-related occupational hazards and adverse pregnancy, obstetrical and neonatal outcomes. It is not clear how the medical workplace should be accommodated to improve outcomes for pregnant physicians. High-quality studies are needed and likely feasible.

Project description:BackgroundAnnually 125 million pregnancies are at risk of malaria infection. However, the impact of exposure to malaria in pregnancy on neurodevelopment in children is not well understood. We hypothesized that malaria in pregnancy and associated maternal immune activation result in neurodevelopmental delay in exposed offspring.Methods and findingsBetween April 2014 and April 2015, we followed 421 Malawian mother-baby dyads (median [IQR] maternal age: 21 [19, 28] years) who were previously enrolled (median [IQR] gestational age at enrollment: 19.7 [17.9, 22.1] weeks) in a randomized controlled malaria prevention trial with 5 or 6 scheduled assessments of antenatal malaria infection by PCR. Children were evaluated at 12, 18, and/or 24 months of age with cognitive tests previously validated in Malawi: the Malawi Developmental Assessment Tool (MDAT) and the MacArthur-Bates Communicative Development Inventories (MCAB-CDI). We assessed the impact of antenatal malaria (n [%] positive: 240 [57.3]), placental malaria (n [%] positive: 112 [29.6]), and maternal immune activation on neurocognitive development in children. Linear mixed-effects analysis showed that children exposed to antenatal malaria between 33 and 37 weeks gestation had delayed language development across the 2-year follow-up, as measured by MCAB-CDI (adjusted beta estimate [95% CI], -7.53 [-13.04, -2.02], p = 0.008). Maternal immune activation, characterized by increased maternal sTNFRII concentration, between 33 and 37 weeks was associated with lower MCAB-CDI language score (adjusted beta estimate [95% CI], -8.57 [-13.09, -4.06], p < 0.001). Main limitations of this study include a relatively short length of follow-up and a potential for residual confounding that is characteristic of observational studies.ConclusionsThis mother-baby cohort presents evidence of a relationship between malaria in pregnancy and neurodevelopmental delay in offspring. Malaria in pregnancy may be a modifiable risk factor for neurodevelopmental injury independent of birth weight or prematurity. Successful interventions to prevent malaria during pregnancy may reduce the risk of neurocognitive delay in children.

Project description:Background:Studies of antiretroviral therapy (ART) use during pregnancy in HIV-infected women have suggested that ART exposure may be associated with adverse birth outcomes. However, there are few data from sub-Saharan Africa where HIV is most common, and few studies involving the World Health Organization's (WHO's) recommended first-line regimens. Methods:We enrolled consecutive HIV-infected pregnant women and a comparator cohort of uninfected women at a primary-level antenatal care facility in Cape Town, South Africa. Gestational assessment combined clinical history, examination and ultrasonography; outcomes included preterm (PTD), low birthweight (LBW) and small for gestational age (SGA) deliveries. In analysis we compared birth outcomes between HIV-infected and -uninfected women, and HIV-infected women who initiated ART before vs during pregnancy. Results:In 1554 women (mean age 29 years) with live singleton births at time of analysis, 82% were HIV-infected, 92% of whom received a first-line regimen of tenofovir, emtricitabine and efavirenz. Overall, higher levels of PTD [22% vs 13%; odds ratio (OR) 1.94, 95% confidence interval (CI): 1.34, 2.82] and LBW (14% vs 9%; OR 1.62, 95% CI: 1.05, 2.29) were observed in HIV-infected vs uninfected women, although SGA deliveries were similar (9% vs 11%; OR 1.06, 95% CI: 0.71, 1.61). Adjusting for demographic characteristics and HIV disease measures, HIV-infected (vs HIV-uninfected) women had persistently increased odds of PTD [adjusted odds ratio (AOR) 2.03; CI 1.33, 3.10]; associations with LBW were attenuated (AOR 1.47; CI 0.90, 2.40). Among all HIV-infected women, there appeared to be no association between the timing of ART initiation (before or during pregnancy) and adverse birth outcomes. Conclusions:These findings suggest that current WHO-recommended ART regimens appear relatively safe in pregnancy, although more data are required to understand the aetiology of preterm delivery in HIV-infected women using ART.

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Pregnancy outcomes of women exposed to laninamivir during pregnancy.

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Pregnancy outcomes of women exposed to laninamivir during pregnancy.

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