Summary Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the ...feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries. Methods In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov , number NCT01084096. Findings The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47 394 livebirths (2520 5% less than 5th percentile for birthweight) and 50 control clusters with 50 743 livebirths (2258 4% less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk RR 0·96, 95% CI 0·87–1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio OR 1·67, 1·33–2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02–1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48 219 women in the intervention group and 867 (2%) of 51 523 in the control group (OR 1·45, 1·33–1·58, p<0·0001). Interpretation Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased. Funding Eunice Kennedy Shriver National Institute of Child Health and Human Development.
We conducted an overview of systematic reviews (SRs) summarizing the best evidence regarding the effect of COVID-19 on maternal and child health following Cochrane methods and PRISMA statement for ...reporting (PROSPERO-CRD42020208783). We searched literature databases and COVID-19 research websites from January to October 2020. We selected relevant SRs reporting adequate search strategy, data synthesis, risk of bias assessment, and/or individual description of included studies describing COVID-19 and pregnancy outcomes. Pair of reviewers independently selected studies through COVIDENCE web-software, performed the data extraction, and assessed its quality through the AMSTAR-2 tool. Discrepancies were resolved by consensus. Each SR's results were synthesized and for the most recent, relevant, comprehensive, and with the highest quality, by predefined criteria, we presented GRADE evidence tables. We included 66 SRs of observational studies out of 608 references retrieved and most (61/66) had "critically low" overall quality. We found a relatively low degree of primary study overlap across SRs. The most frequent COVID-19 clinical findings during pregnancy were fever (28-100%), mild respiratory symptoms (20-79%), raised C-reactive protein (28-96%), lymphopenia (34-80%), and pneumonia signs in diagnostic imaging (7-99%). The most frequent maternal outcomes were C-section (23-96%) and preterm delivery (14-64%). Most of their babies were asymptomatic (16-93%) or presented fever (0-50%), low birth weight (5-43%) or preterm delivery (2-69%). The odds ratio (OR) of receiving invasive ventilation for COVID-19 versus non-COVID-19 pregnant women was 1.88 (95% Confidence Interval CI 1.36-2.60) and the OR that their babies were admitted to neonatal intensive care unit was 3.13 (95%CI 2.05-4.78). The risk of congenital transmission or via breast milk was estimated to be low, but close contacts may carry risks. This comprehensive overview supports that pregnant women with COVID-19 may be at increased risk of adverse pregnancy and birth outcomes and low risk of congenital transmission.
•COVID-19 during pregnancy imposes a risk of severe disease and adverse birth outcomes.•Data about the safety of vaccination against COVID-19 for pregnant women is limited.•COVID-19 vaccination ...coverage among pregnant persons is suboptimal.•We found no safety concerns for COVID-19 vaccination during pregnancy.•Our findings support authorized or approved COVID-19 vaccines for pregnant persons.
Assessment of COVID-19 vaccines safety during pregnancy is urgently needed.
We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185).
We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants.
A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination.
Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49–15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56–2.12). Animal studies showed consistent results with studies in pregnant persons.
We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.
Congenital Chagas disease: an update Carlier, Yves; Sosa-Estani, Sergio; Luquetti, Alejandro O ...
Memórias do Instituto Oswaldo Cruz,
05/2015, Letnik:
110, Številka:
3
Journal Article
Recenzirano
Odprti dostop
Congenital infection with Trypanosoma cruzi is a global problem, occurring on average in 5% of children born from chronically infected mothers in endemic areas, with variations depending on the ...region. This presentation aims to focus on and update epidemiological data, research methods, involved factors, control strategy and possible prevention of congenital infection with T. cruzi. Considering that etiological treatment of the child is always effective if performed before one year of age, the diagnosis of infection in pregnant women and their newborns has to become the standard of care and integrated into the surveillance programs of syphilis and human immunodeficiency virus. In addition to the standard tests, polymerase chain reaction performed on blood of neonates of infected mothers one month after birth might improve the diagnosis of congenital infection. Recent data bring out that its transmission can be prevented through treatment of infected women before they become pregnant. The role of parasite genotypes and host genetic factors in parasite transmission and development of infection in foetuses/neonates has to be more investigated in order to better estimate the risk factors and impact on health of congenital infection with T. cruzi.
The World Health Organization (WHO) Technical Group on “Prevention and Control of Congenital Transmission and Case Management of Congenital Infections with Trypanosoma cruzi” recommendations are ...similar to the gold standard approach defined by PAHO 3,4. Howard EJ, Xiong X, Carlier Y, Sosa-Estani S, Buekens P. Frequency of the congenital transmission of Trypanosoma cruzi: a systematic review and meta-analysis. Geographic Variations in Test Reactivity for the Serological Diagnosis of Trypanosoma cruzi Infection.
Congenital syphilis is preventable through timely access to prenatal care, syphilis screening and treatment of pregnant women diagnosed as infected. In 2018, California had the second highest number ...of congenital syphilis cases in the United States (U.S.), a nearly twofold increase in cases since 2014. This study assessed gaps in preventing congenital syphilis in the high morbidity region of Kern County, California.
Between May 2018 and January 2019, we conducted five focus group discussions with pregnant/postpartum women and ten semi-structured interviews with prenatal care providers in Kern County. Focus group and interview data were recorded, transcribed, and analyzed to identify emergent themes pertaining to facilitators and barriers at each step (prenatal care, syphilis screening and treatment) in the congenital syphilis prevention cascade.
Gaps in congenital syphilis prevention discussed in focus group discussions with pregnant/postpartum women were related to limited prenatal care access, social-, economic-, and cultural-barriers, and substance use and co-occurring intimate partner/domestic violence. The gaps identified from interviews with prenatal care providers included social economic vulnerabilities of pregnant women and stigma and shame around the vulnerabilities, distrust in medical system, prenatal substance use, limited prenatal substance use disorder treatment facilities, and inadequate provider training on context-specific congenital syphilis management strategies. Gaps in partner notification, screening and treatment for syphilis were brought up by pregnant/postpartum women and prenatal care providers.
Congenital syphilis continues to increase in Kern County and throughout the U.S. In high syphilis morbidity areas, comprehensive and tailored public health approaches addressing setting-specific gaps in prenatal screening and treatment are needed.
Abstract
Background
Congenital syphilis (CS) has reemerged as a global maternal and child health crisis. Kern County, California and East Baton Rouge Parish, Louisiana are among the highest CS ...morbidity regions in the United States. We previously reported on social-ecological and structural barriers to prenatal care and maternal syphilis testing and treatment in these two regions. The aim of this study was to examine perinatal patient’s health preferences and perceptions of patient-provider relationships in the prenatal care clinic setting.
Methods
Between May 2018 and January 2019 we conducted 20 in-depth qualitative interviews with prenatal providers and 8 focus group discussions with pregnant and postpartum individuals in Kern County and East Baton Rouge Parish. We applied an adapted health services framework to analyze participants’ understanding of health disparities and vulnerable populations; perinatal patient’s health and prenatal care preferences; and participants’ perspectives of clinical encounters in the context of prenatal care and maternal syphilis testing and treatment.
Results
Site-specific determinants of syphilis infection emerged but participants from both locations felt CS prevention efforts should be prioritized among youth, racial/ethnic minority populations, people experiencing socioeconomic limitations and people with other commonly occurring health conditions. Although perinatal patients expressed clear health preferences, they reported inconsistent receipt of respectful, patient-centered care. Inconsistencies were connected with limited ethnic and cultural competence among providers, and implicit, negative attitudes toward patients using substances, experiencing homelessness, or engaging in sex work. Providers clearly aimed to offer high quality prenatal care. However, some clinic and health systems level factors were thought to reduce positive and communicative patient-provider relationships, contributing to gaps in use of prenatal care and syphilis testing and treatment.
Conclusions
Our findings suggest that interventions tailored to address setting-specific determinants (including clinic and health system factors) of disparities in CS risk could improve pregnant people’s access to prenatal care and ensure they and their sex partners receive timely syphilis screening and treatment. We recommend all prenatal care providers receive training on how to identify and mitigate implicit biases and provide competent and compassionate patient-centered care.
Mobile health (mHealth) is emerging as a useful tool to improve healthcare access especially in the developing world, where limited access to health services is linked to poor antenatal care, and ...maternal and perinatal mortality.The objective of this study is to 1) understand pregnant women's access and usage of cell phones and 2) survey the health information needs and interests in a population attending public hospitals and health centers of two cities in Argentina. This information is not available and it is the basis to develop a strategy for improving maternal care via cell phones.
Questionnaires were verbally administered to pregnant women who were attending an antenatal care visit in community health centers and public hospitals in Rosario, Santa Fe and Mercedes, Corrientes. Participants were 18 years of age or older and had previously given birth. The data obtained was qualitative and analyzed using SPSS version 18.
A total of 147 pregnant women meeting inclusion criteria (Rosario: 63; Mercedes: 84) were approached and verbally consented to participate. The average age was 29.5 years, most lived in urban areas (89%) with a mean travel time of 43.4 minutes required to get to the health center and 57.3 minutes to get the hospital.Ninety-six percent of women (n = 140) responded that they would like to receive text messages and cell phone calls with information regarding prenatal care, although the topics and period of time to receive information varied greatly.
Considering the vast majority of the interviewed women had access to and were interested in receiving text messages and calls with educational information regarding pregnancy and infant health, pregnant women in Argentina could benefit from such an mHealth program. The low access to Internet suggests it is not an option for this population; however, this cannot be assumed as representative of the country's situation.To retain active participation, other forms of health communication, such as a 2-way text message systems or toll-free numbers, could be considered in the future. Cost of use and implementing these options should be studied.
•Pregnant persons with COVID-19 may present with severe illness and adverse pregnancy or birth outcomes.•Data about the safety of vaccination against COVID-19 for pregnant persons is ...limited.•COVID-19 vaccines selected by COVAX showed no evidence of pregnancy-associated safety concerns.•Pregnant persons may consider receiving these vaccines.•Benefits could be higher for pregnant persons at high risk of exposure or with comorbidities.
Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed.
We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185).
We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.
This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.