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1.
medrxiv; 2024.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2024.04.10.24305634

RESUMEN

The COVID-19 pandemic has significantly impacted the continuity of maternity care in Burkina Faso. This study aimed to compare the volumes of in-person visits and explore the experiences of healthcare providers and users regarding the continuity of healthcare in the maternity ward of a Health and Social Promotion Center (HSPC) before, during, and after the lockdown during the COVID-19 pandemic in Ouagadougou, Burkina Faso. Methods We conducted a multimethod, cross-sectional exploratory study with a phenomenological approach. Monthly health administrative data regarding family planning visits, antenatal visits, deliveries, and postnatal care before, during, and after COVID-19 were collected and compared. Qualitative data were collected through semi-structured interviews with family healthcare providers and users and thematically analyzed. Results The study found that the pandemic led to a decline in the demand for healthcare, as people were afraid of contracting COVID-19. This was particularly true for pregnant women who had recently given birth. The study also found that the pandemic disrupted the supply of essential medicines and medical supplies, which made it difficult for healthcare providers to provide quality care. The qualitative analysis allowed us to highlight three themes: the representation of respondents on COVID-19, their perception of the effectiveness of barrier measures and their analysis of the continuity of care in times of COVID-19: the picture of respondents on COVID-19, their perception of the efficacy of barrier measures and their analysis of the continuity of care in times of COVID-19. Despite these challenges, the study found that healthcare providers and users could find ways to maintain continuity of care. Conclusion The study concludes that the COVID-19 pandemic has significantly impacted the continuity of maternity care in Burkina Faso. However, healthcare providers and users have found ways to maintain continuity of care, and the study provides recommendations for improving continuity of care in the future.


Asunto(s)
COVID-19
2.
researchsquare; 2024.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-4248233.v1

RESUMEN

Introduction: This study aimed to explore the direct and indirect influences of COVID-19-related restrictions on adolescents and young people's SRHR in Malawi, Zambia, and Zimbabwe, with a focus on teenage pregnancy and access to and utilization of HIV testing and counselling services. Methods: A qualitative case study in a larger mixed-methods study design was used. Thirty-four interviews and four group discussions were conducted with relevant stakeholders in Malawi, Zambia and Zimbabwe. In Zambia, adolescents and young people were included and asked to describe their experience/perceptions of the impact of COVID-19 on their SRHR. Content and thematic analysis were used to analyze the data, Results: Priority shifts resulted in the focus of service provision to the COVID-19 response, shortages of already insufficient human resources due to infection and/or isolation, supply chain disruptions leading to shortages of important SRH-related commodities and supplies, compromised quality of services such as counselling for HIV and overall limited AYP’s access to SRH information. Suggestions for interventions to improve SRH services include the need for a disaster preparedness strategy, increased funding for ASRHR, the use of community health workers and community-based ASRHR strategies, and the use of technology and social media platforms such as mhealth. Conclusion:Disruption of SRH services for AYP due to pandemic related-restrictions, and diversion of resources/funding has had a ripple effect that may have long-term consequences for AYP throughout the East and Southern African region. This calls for further investment in AYP’s access to SRHR services as progress made may have been deterred.


Asunto(s)
COVID-19 , Infecciones por VIH
3.
researchsquare; 2024.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-4185718.v1

RESUMEN

This study compared the humoral immune characteristics of children, elderly people, pregnant women, and adults infected with BA.5 and XBB strains in Guangzhou, China. It was found that binding and neutralizing antibodies the titers against distinct SARS-CoV-2 strains were low in the acute-phase sera of BA.5 infected patients, while the corresponding titers were significantly increased in the convalescent phase, the antibody titers against the Wuhan strain were the highest. Regardless of whether they were vaccinated, BA.5 infection did not induce high neutralizing antibodies against XBB. During the recovery phase, the titers of antiviral antibodies in the vaccinated population are more robust than those in the unvaccinated population. For BA.5 infections, the specific binding and neutralizing antibody titers in the children group were lower compared to other population groups. In the convalescence period of the disease, the titers of neutralizing antibodies against Wuhan, BA.5 and XBB strains induced by BA.5 infections are significantly correlated in pairs. XBB can induce a broader and balanced antiviral humoral immune response than BA.5 as a first-time infected strain. This finding can provide a reference for the judgment of the future epidemic law of SARS-CoV-2, and provide a scientific basis for developing novel COVID-19 vaccines, especially for discovering customized vaccines and immune strategies for different populations.


Asunto(s)
COVID-19 , Infecciones
4.
researchsquare; 2024.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-4181580.v1

RESUMEN

Background: Health emergencies, including pandemics, are not entirely new occurrences; some notable ones occurred in the past. However, the scale of the COVID-19 pandemic is unprecedented. The COVID-19 pandemic exposed the unpreparedness of national health systems in effectively managing health emergencies. During the pandemic, controlling the spread of the virus and hopes of exiting into a post-pandemic era were reliant on research to improve patient care and inform government policies. Nonetheless, research implementation during health emergencies can be challenging in low-resourced settings. This paper presents anecdotes of experiences encountered in implementing a research project during the COVID-19 pandemic in Gujarat, India, and offers insights into ways research can be supported during health emergencies. Methods: We implemented a longitudinal study to investigate the impact of the COVID-19 pandemic, including SARS-CoV-2 infection, during pregnancy on birth outcomes, growth, and development in early childhood. The study utilises hospital records and databases to recruit women who were infected with SARS-CoV-2 during pregnancy and those with no known infection. Mother-infant pairs in the infected and uninfected group were then followed longitudinally for over 3 years. Results: Observations of challenges encountered during implementation of the research, including those related to planning, retrieval of hospital records, tracking, recruitment, and follow-up of eligible women were recorded by study staff, and the observations produced as anecdotes. The challenges observed are group into three overarching themes: a) individual factors, b) health system challenges, and c) research operational challenges. Some notable observations include misinformation, misconception, mistrust, underdeveloped health record systems, stigma, and hesitance. Conclusion: We believe early planning, effective communication, and community awareness are likely to be helpful in implementing a successful research project. Additionally, efforts at improving collaboration and co-creation between health practitioners, researchers and the public may benefit the implementation of research projects during a health emergency.


Asunto(s)
COVID-19
5.
researchsquare; 2024.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-4170144.v1

RESUMEN

Background: The Coronavirus Disease 2019 (COVID-19) pandemic has significantly impacted the management and prevalence of gestational diabetes mellitus (GDM) among pregnant women worldwide. This study aimed to investigate the effects of the pandemic on GDM prevalence and oral glucose tolerance test (OGTT) characteristics in Hongshan District, Wuhan, China. Methods: We retrospectively analyzed data from 91,932 pregnant women screened for GDM before (January 1, 2018, to December 31, 2019) and after (January 1, 2020, to December 31, 2021) the onset of the COVID-19 pandemic. The study focused on changes in GDM prevalence, OGTT positive rates and glucose value distribution, and the diagnostic performance of OGTT. Results: The prevalence of GDM increased significantly from 14.5% (95% CI, 14.2-14.8%) pre-pandemic to 21.9% (95% CI, 21.5-22.4%) post-pandemic. A notable rise in OGTT positive rates was observed across all time points, with the most significant increase at the 0-hour mark. Regression analysis indicated a significant risk increase for GDM during the pandemic, even after adjusting for age. Diagnostic accuracy of the 0-hour OGTT improved in the pandemic era, with the area under the curve (AUC) rising from 0.78 to 0.79 and sensitivity from 0.56 to 0.58. Median OGTT values at all time points significantly increased post-pandemic, even after adjusting for age, indicating a shift in glucose metabolism among the study population. Conclusion: The COVID-19 pandemic has led to a significant increase in the prevalence of GDM among pregnant women in Hongshan District, Wuhan. This is evidenced by the elevated rates of positive OGTT and altered median glucose values, indicating a shift in glucose metabolism. These findings underscore the profound impact of the pandemic on maternal and neonatal health. They emphasize the imperative for continuous monitoring and the development of updated, localized diagnostic criteria for OGTT to enhance the identification and treatment of GDM during and after global health crises.


Asunto(s)
COVID-19 , Diabetes Mellitus , Trastornos del Metabolismo de la Glucosa , Diabetes Gestacional
6.
preprints.org; 2024.
Preprint en Inglés | PREPRINT-PREPRINTS.ORG | ID: ppzbmed-10.20944.preprints202403.1341.v1

RESUMEN

Introduction: The emergency of the SARS-CoV-2 virus spread and its subsequent global pan-demic have raised significant concerns regarding its impact on pregnancy outcomes. This review aims to summarize the emerging data on the risk of preterm delivery in pregnant women infected with SARS-CoV-2. Materials and Methods: A systematic search was conducted from March 2020 to December 2023 using PubMed, following PRISMA guidelines. Studies correlating maternal COVID-19 infection with preterm birth were included. Results: Thirteen studies were analyzed, indicating a higher incidence of preterm birth in SARS-CoV-2 positive pregnant women compared to controls. The average incidence rate of pre-term birth in infected patients was 18.5%, with a median of 12.75%, while non infected women showed an average incidence of preterm birth of 10% with a median of 8.2%. Discussion: Studies suggest an association between SARS-CoV-2 infection during pregnancy and increased risk of preterm birth and cesarean section. Severity of symptoms and underlying comorbidities further elevate this risk. Notably, infections during the third trimester pose the highest risk of preterm birth. Conclusion: Preventing SARS-CoV-2 infection during pregnancy is crucial to mitigate adverse obstetric outcomes. Close monitoring and tailored interventions for infected pregnant women, particularly those in later trimesters and with comorbidities, are imperative to reduce the risk of preterm birth and improve maternal-fetal outcomes.


Asunto(s)
COVID-19 , Anomalías Inducidas por Medicamentos
7.
medrxiv; 2024.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2024.03.18.24304517

RESUMEN

Coronavirus disease 2019 (COVID-19), when contracted by pregnant women, can lead to severe respiratory illness, rapid disease progression, and higher rates of intensive care unit admission. COVID-19 infection during pregnancy is associated with an increased risk of preterm delivery, cesarean section, fetal dysfunction, preeclampsia, and perinatal death. Additionally, vertical transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from pregnant women to their fetuses has been observed. While severe infections in neonates and infants are rare, newborns can experience serious consequences from COVID-19, despite their suboptimal humoral immune system protection. The amino acids in the structural proteins of SARS-CoV-2 are subjected to constant mutation. Since around January 2023, COVID-19, caused by infection with omicron-type SARS-CoV-2 variants, has been prevalent globally. Omicron-type SARS-CoV-2 variants can evade the immune response triggered by traditional mRNA-based COVID-19 vaccines, such as BNT162b2. Therefore, vaccination with a vaccine (BNT162b2 XBB.1.5) that can provide protection against omicron-type SARS-CoV-2 variants is recommended. Therefore, we examined the titers of anti-spike glycoprotein of SARS-CoV-2 IgG and IgA in the blood and umbilical cord blood obtained from pregnant women vaccinated with BNT162b2 XBB.1.5. The results showed that anti-spike glycoprotein of SARS-CoV-2 IgG and IgA titers were highest in the blood and cord blood obtained from pregnant women vaccinated with BNT162b2 XBB.1.5 at late gestational age (28-34 weeks). No serious side effects or adverse events caused by vaccination of pregnant women with BNT162b2 XBB.1.5 were observed in either pregnant women or newborns. In the future, to validate our findings, large cohort clinical studies involving numerous pregnant women must be conducted.


Asunto(s)
Infecciones por Coronavirus , Síndrome Respiratorio Agudo Grave , Muerte , COVID-19 , Enfermedades Fetales , Insuficiencia Respiratoria
8.
medrxiv; 2024.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2024.02.27.24303454

RESUMEN

Introduction:   Pregnant women are considered a high-risk group for COVID-19, and a priority for vaccination. Routine antenatal (ANC) care provides an opportunity to track trends and factors associated with vaccine uptake. We sought to evaluate COVID-19 vaccine uptake among pregnant women attending ANC in Zambia.   Methods  We conducted a repeated cross-sectional study in 39 public health facilities in four districts in Zambia from September 2021 to September 2022. Pregnant women who were aged 15-49 years were enrolled during their first ANC visit. Every month, ~20 women per facility were interviewed during individual HIV testing and counseling. We estimated vaccine uptake as the proportion of eligible participants who self-reported having received the COVID-19 vaccine.   Results   A total of 9,203 pregnant women were screened, of which 9,111 (99%) were eligible and had vaccination status. Of the 9,111 included in the analysis, 1,818 (20%) had received the COVID-19 vaccine during the study period, with a trend of increasing coverage with time (0.5% in September 2020, 27% in September 2022). Conversely, 3,789 (42%) reported not being offered a COVID-19 vaccine. We found that older age, education, employment status, and prior COVID-19 infection were significantly associated with vaccine uptake.     Conclusion  COVID-19 vaccine uptake among pregnant women was lower than estimates from the general population (27% across the four districts in September 2022), pointing to missed opportunities to protect this high-risk group. ANC visits were a viable point for conducting COVID-19 surveillance. Incorporating the vaccine as part of the routine ANC package might increase coverage in this group.


Asunto(s)
COVID-19
9.
medrxiv; 2024.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2024.02.23.24302446

RESUMEN

Underserved communities in low-resource countries are disproportionately impacted by communicable diseases when compared to those in developed countries. These communities have limited access to life saving diagnostic laboratory tests making it difficult to treat communicable diseases like SARS-CoV-2 and Human Immunodeficiency Virus (HIV). Rapid diagnostic tests, like the COVID-19 antigen (Ag) test, play a crucial role in underserved communities by enabling fast and inexpensive diagnosis in low-resource settings. Unfortunately, these rapid test platforms often lack the accuracy and precision of their laboratory-based analogs, resulting in a need for improved rapid diagnostics. The World Health Organization’s (WHO) ASSURED (Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free, and Deliverable to end-users) criteria are often referenced in the development of diagnostic tests. In this work, we aim to provide guidance to the “user-friendly” component of ASSURED through end-user surveys taken in rural Kenya. In these surveys, we examine the user-friendliness of two of the most commonly used rapid diagnostic tests, the COVID-19 Ag test and pregnancy test, by assessing participants’ familiarity with the tests, their opinion of test appearance, and the perceived complexity of the operator’s workflow. We also examine community acceptance and desire for a self-test for the highly stigmatized HIV. We intend these results to help guide developers of future rapid diagnostic tests intended for low-resource communities.


Asunto(s)
COVID-19 , Infecciones por VIH
10.
ISRCTN; 26/02/2024; TrialID: ISRCTN17980894
Clinical Trial Register | ICTRP | ID: ictrp-ISRCTN17980894

RESUMEN

Condition:

Regulation of COVID19 receptor protein by vitamin D and exercise
Not Applicable

Intervention:

Thirty healthy young volunteers (15 males and 15 females) will be recruited to test the effects of Vit D3 dietary supplementation or placebo in oral mucosae and skeletal muscle ACE2 protein expression. Before administering supplements, a 10 mL resting blood sample will be obtained to determine their health status (general biochemistry and hemogram).

Two weeks later, the main experiments will start, comprising two supplementation trials (5 days) in a double-blind crossover design, including two conditions: placebo or Vit D supplementation. On each trial, subjects will report to the laboratory at 7:00 a.m. and after the ingestion of the last dose of a placebo or Vit D3 (assigned randomly using an online tool). The corresponding supplement (placebo or Vit D3) will be administered in 3 doses of 25000 IU of Vit D3 on alternate days for 5 days (i.e., days 1, 3, and 5). On the 5th day in the morning, a 20 mL blood sample will be obtained from the femoral vein after ingesting the corresponding supplement. This will be followed by a collection of buccal mucosae cells with a cytobrush, and a muscle biopsy will be taken from the musculus vastus lateralis with the Bergstrom technique. The baseline sprint capacity (10 s all-out), VO2max, maximum fat oxidation capacity (indirect calorimetry) and muscle O2 extraction capacity (near-infrared spectroscopy, NIRS) will be assessed. Subjects will perform incremental exercise to exhaustion, followed by 20 seconds of ischaemia, a final 10 s all-out sprint, immediately followed by 1 minute of ischaemia applied in only one leg. At the end of the ischaemia, a bilateral muscle biopsy (occluded and non-occluded leg) will be obtained at the end of the exercise test performed with supplements, followed five min later by the collection of a 20 mL

Primary outcome:

Skeletal muscle protein expression levels of ACE2 measured using western blotting at baseline and at the end of the exercise.

Criteria:

Inclusion criteria: 1. Males and females between 18 and 40 years old
2. Physically active, but not submitted to periodized training.


Exclusion criteria: 1. Medical contraindications for maximal exercise
2. Smoking
3. Taking drugs or medications
4. Taking supplements
5. Fainting when seeing blood
6. Not being able to pedal
7. Carrying orthopaedic prosthesis
8. Pregnancy
9. Basal 25 (OH) vitamin D concentration above 80 ng/mL

11.
ChiCTR; 2024-02-23; TrialID: ChiCTR2400081132
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400081132

RESUMEN

Condition:

Long Covid

Intervention:

healthy group:Maintain daily habits;Rehabilitation group:Maintain daily habits;fatigue patients with Long Covid:Maintain daily habits;

Primary outcome:

Peak cardiorespiratory oxygen uptake;Proteomic features;Metabolomics profile;

Criteria:

Inclusion criteria: 1. Inclusion criteria for healthy populations
(1) No history of novel coronavirus infection and SARS infection or morbidity
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
2. Inclusion criteria for persons recovering from novel coronavirus infection
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses and no sequelae such as fatigue or malaise 12 weeks after the diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
3. Long Covid with Fatigue Patient Inclusion Criteria
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses with sequelae such as fatigue and malaise 12 weeks after diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time

Exclusion criteria: Subjects with the following conditions should be excluded:
(1) Pulmonary embolism;
(2) Absolute and relative contraindications to cardiopulmonary exercise testing or exercise training;
(3) Obvious arrhythmia or ischemia during low-intensity exercise and severe pulmonary hypertension;
(4) Severe pulmonary diseases (e.g., chronic obstructive pulmonary disease, severe COVID-19-related symptoms, severe asthma);
(5) Recent cardiovascular events (cardiac decompensation, angioplasty or cardiac surgery less than 4 weeks, valvular heart disease requiring surgical correction, pericarditis, fatigue caused by various arrhythmias);
(6) Renal failure requiring dialysis;
(7) Patients with New York Heart Association (NYHA) class ? or recurrent malignant arrhythmia;
(8) Drug-induced muscle atrophy, such as steroids or neuromuscular blocking drugs;
(9) Metabolic diseases ( such as hyperglycemia, malnutrition), and weakness caused by electrolyte disturbances;
(10) Myalgic encephalomyelitis/chronic fatigue syndrome;
(11) Allergic to known components of study drugs;
(12) Refusal to sign informed consent;
(13)Those who participated in other clinical trials or used Chinese medicine (proprietary Chinese medicine) in the last three months.

12.
ChiCTR; 2024-02-23; TrialID: ChiCTR2400081131
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400081131

RESUMEN

Condition:

long-covid syndrome

Intervention:

treatment group:Chinese Herbal Medicine and Snap-Needle Therapy;control group:Western medicine for symptomatic treatment;

Primary outcome:

Chinese Medicine Score;

Criteria:

Inclusion criteria: ?Patients who meet the above diagnostic criteria of traditional Chinese medicine and western medicine;
? Age 18-65 years old, gender is not limited;
? Patients more than 1 week after negative nucleic acid or antigen test;
? Patients with symptoms of impaired cardiopulmonary function, such as cough, fatigue, palpitation, etc., which last for no more than half a year after turning negative from nucleic acid or antigen test;
? Patient's TCM evidence points, according to the symptoms in the recovery period, the primary symptoms are evaluated according to 0, 1, 2, 3 points, and the secondary symptoms are evaluated according to the presence or absence of the symptoms, using 1 or 0 points, and the sum of the scores is recorded as the TCM evidence points, and the higher the score, the more serious the condition is.
? Patients volunteered to be tested and signed an informed consent form.

Exclusion criteria: ?Patients with severe interstitial lung disease, bronchiectasis, and other underlying lung diseases;
? Patients with underlying diseases such as congenital respiratory malformations and congenital heart disease;
? Patients with severe cardiac, hepatic, renal dysfunction and abnormal coagulation function;
?Patients with diseases that affect cognitive function, such as alcoholism, drug addiction or psychotropic substance abuse;
? People with history of needle fainting and skin infection at the site of needling;
? Patients who are allergic to Chinese medicinal preparations;
? Pregnant or lactating women;
? Those who are participating in other clinical trials or those who have participated in other clinical trials for less than 3 months. Those who meet any of the above criteria should be excluded.

13.
medrxiv; 2024.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2024.02.20.24302892

RESUMEN

Maternal stress and viral illness during pregnancy are associated with neurodevelopmental conditions in offspring. Children born during the COVID-19 pandemic, including those exposed prenatally to maternal SARS-CoV-2 infections, are reaching the developmental age for the assessment of risk for neurodevelopmental conditions. We examined associations between birth during the COVID-19 pandemic, prenatal exposure to maternal SARS-CoV-2 infection, and rates of positive screenings on the Modified Checklist for Autism in Toddlers-Revised (M-CHAT-R). Data were drawn from the COVID-19 Mother Baby Outcomes (COMBO) Initiative. Participants completed the M-CHAT-R as part of routine clinical care (COMBO-EHR cohort) or for research purposes (COMBO-RSCH cohort). Maternal SARS-CoV-2 status during pregnancy was determined through electronic health records. The COMBO-EHR cohort includes n=1664 children (n=442 historical cohort, n=1222 pandemic cohort; n=997 SARS-CoV-2 unexposed prenatally, n=130 SARS-CoV-2 exposed prenatally) who were born at affiliated hospitals between 2018-2023 and who had a valid M-CHAT-R score in their health record. The COMBO-RSCH cohort consists of n=359 children (n=268 SARS-CoV-2 unexposed prenatally, n=91 SARS-CoV-2 exposed prenatally) born at the same hospitals who enrolled into a prospective cohort study that included administration of the M-CHAT-R at 18-months. Birth during the pandemic was not associated with greater likelihood of a positive M-CHAT-R screen in the COMBO-EHR cohort. Maternal SARS-CoV-2 was associated with lower likelihood of a positive M-CHAT-R screening in adjusted models in the COMBO-EHR cohort (OR=0.40, 95% CI=0.22 - 0.68, p=0.001), while analyses in the COMBO-RSCH cohort yielded similar but non-significant results (OR=0.67, 95% CI=0.31-1.37, p=0.29).These results suggest that children born during the first 18 months of the COVID-19 pandemic and those exposed prenatally to a maternal SARS-CoV-2 infection are not at greater risk for screening positive on the M-CHAT-R.


Asunto(s)
Síndrome Respiratorio Agudo Grave , Trastorno Autístico , COVID-19 , Anomalías Inducidas por Medicamentos , Discapacidades del Desarrollo
14.
researchsquare; 2024.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-3976375.v1

RESUMEN

Background:The advent of COVID-19 pandemic has dramatically affected women’s life and livelihoods. In the past decade, the promotion of family planning contributed to reduced poverty and averted poor maternal and child outcomes. There is evidence that these gains may be threatened by social restrictions following COVID-19 outbreak. Methods:We used data from a longitudinal survey collected by the Performance Monitoring Accountability in Burkina Faso. Data were collected over one-year period, from before (November 2019–February 2020) and during (November 2020–February 2021) COVID-19 pandemic. We evaluate changes in reproductive outcomes with respect to changes in health and economic circumstances as well as sociodemographic conditions among 1372 women aged 15-49 at risk of pregnancy and potential contraceptive users. Bivariate and multivariate multinomial logistic regression were performed to examine correlates of reproductive outcomes. Results:Half (52%) of women did not change their reproductive status. While, 29% had childbearing, 19% started using a contraceptive method. In the multivariate analysis, childbearing was relatively higher among women exposed to family planning promotion, healthcare utilization, but relatively lower among those employed without cash paid and those who experienced household income loss. As of contraception, women exposed to family planning promotion were also associated with a relatively higher contraceptive use while concerns about getting COVID-19 infection had the opposite effect. Conclusion:After a year period of COVID-19 outbreak, contraceptive adoption increased significantly, but at a slower pace which was not enough to reduce childbearing. The most vulnerable women may remain at greater risk of unintended pregnancies and poor maternal and child outcomes. Therefore, family planning programs should direct their efforts into combatting misinformation and reaching out women in communities in the context of COVID-19 restrictions.


Asunto(s)
COVID-19
15.
medrxiv; 2024.
Preprint en Inglés | medRxiv | ID: ppzbmed-10.1101.2024.02.18.24302492

RESUMEN

Background There were many unknowns for pregnant women during the COVID-19 pandemic. Most of these could have been silent however lethal and anemic conditions could escalate the worsening of pregnancy outcomes. Existing evidence indicate that, array of factors is associated with the ability of compromising maternal anemia, some directly and others indirectly. Objective This review aimed at ascertaining the pooled effect of several anemia interventions. Specifically, the aim of this study was to establish if pregnancy status is associated with COVID-19 severity characterized by a cytokine storm. Methods We searched the Google Scholar, PubMed, Scopus, Web of Science, and Embase databases to studies suitable for inclusion in this meta-analysis. Studies examining women of reproductive age on any maternal anemia intervention were included. The risk of bias was assessed using the Cochrane risk of bias tool. Review Manager 5.4.1 was used to calculate rate ratios (RRs) with 95% CIs, which were depicted using forest plots. Quantitative variables were summarized in total numbers and percentages. The effect on prevention, control, management and or treatment of anemia was calculated and compared between the intervention and the comparator arms. Heterogeneity was evaluated with the Cochran Q statistic and Higgins test. Results A total of 11 articles including data for 6,129 were included. With sensitivity analysis, the interventions had a utility of 39% on maternal anemia prevention and management (random effects model RR 0.61, 95% CI 0.43, 0.87; P = 0.006) (X-squared 6=286.98, P<.00001; I-squared=97%). All the interventions against maternal anemia showed an effect of 17% (fixed-effect model RR 0.83, 95% CI 0.79-0.88; P<.00001) (X-squared 7;24=2.93, P=0.57;I-squared = 0%). Education to pregnant women showed a 28% effect (RR 0.72 95% CI 0.58, 0.89), medicinal administration 19% (RR 0.81 95% CI 0.73, 0.90), iron supplementation 17% (RR 0.83 95% CI 0.75, 0.92) and I.V Ferric Carboxy-maltose 15% (RR 0.85 95% CI 0.74, 0.97) (I-squared = 0%). Interventions in African region had a higher (16%) and significant effect compared to other regions (fixed-effects model RR 0.84, 95% CI 0.79-0.89; P<.001) (X-squared 7;25=176.53, P<.00001;I-squared = 7%). Multiple center studies had a significant predictive effect (16%) compared to single center studies (fixed-effects model RR 0.84, 95% CI 0.79-0.89; P<.00001)(967;25=176.53, P<.00001; I-squared=97%) .The year 2020 recorded the highest effect of maternal anemia interventions at 28% (random-effects model RR 0.72, 95% CI 0.67-0.78; P<.00001) (967;23=167.34, P<.00001; I-squared =98%) Conclusion In the advent of COVID-19, maternal anemia interventions were compromised demonstrated by a low effectiveness trend from the year 2020 to the year 2022. During this period, even the most effective and recommended interventions against maternal anemia were somehow affected.


Asunto(s)
COVID-19 , Anemia
16.
ClinicalTrials.gov; 19/02/2024; TrialID: NCT06278324
Clinical Trial Register | ICTRP | ID: ictrp-NCT06278324

RESUMEN

Condition:

Acute Respiratory Tract Infection;Flu, Human;COVID-19;Common Cold

Intervention:

Device: Nasal Spray HSV Treatment

Primary outcome:

Performance of nasal spray in eliminating viruses

Criteria:


Inclusion Criteria:

- With early symptoms of respiratory infection (onset less than 48 hours before
inclusion) of mild to moderate intensity (TSS = 2 and < 9).

- Having a mobile phone allowing using the patient reported outcome App. (NursTrial®).

- Patient able to understand and comply with protocol requirements and instructions,
including answering a questionnaire on a mobile phone, as required by protocol.

- Signed informed consent.

- Affiliated to a French Health insurance scheme.

Exclusion Criteria:

- Concomitant disease or infection that could interfere with participation in the study:
acute ear, nose, and throat and respiratory tract disease other than the common cold,
flu or COVID (e.g., tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic
rhinitis, or other reasons for nasal obstruction and other past or present conditions
and treatments that could influence symptom scores.

- Severe nasal septum deviation or other conditions that could cause nasal obstruction
such as the presence of nasal polyps.

- Known or suspected intolerance or hypersensitivity, including history of allergies, to
any component investigational device material, any history of drug hypersensitivity.

- Concomitant treatment that might impair the trial results (i.e., decongestants, local
anesthetics, topical corticosteroids, saline solution) during the seven days prior to
inclusion.

- Smokers.

- Have a condition or is taking a medication that the Investigator and/or designee
believes could jeopardize the safety of the subject, would interfere with the
evaluation, or confound the interpretation of the study results.

- Non-compliant or may not respect the constraints imposed by the protocol.

- Enrolled in another clinical trial or being in a period of exclusion from a previous
clinical trial;

- Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using
effective contraception (oral contraceptives, intra-uterine device, contraceptive
implant, or condoms).

- Person belonging to a population referred to in articles 64 (incapacitated subjects),
65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory
military service, persons deprived of liberty, persons who, due to a judicial
decision) and 68 (patients in emergency) of the Medical Device Regulation.


17.
biorxiv; 2024.
Preprint en Inglés | bioRxiv | ID: ppzbmed-10.1101.2024.02.17.580824

RESUMEN

SARS-CoV-2 infection and the resulting coronavirus disease (COVID-19) complicate pregnancies as the result of placental dysfunction which increases the risk of adverse pregnancy outcomes. While abnormal placental pathology resulting from COVID-19 is common, direct infection of the placenta is rare. This suggests maternal response to infection is responsible for placental dysfunction. We hypothesized that maternal circulating extracellular vesicles (EVs) are altered by COVID-19 during pregnancy and contribute to placental dysfunction. To examine this, we characterized maternal circulating EVs from pregnancies complicated by COVID-19 and tested their functional effect on trophoblast cells in vitro. We found the timing of infection is a major determinant of the effect of COVID-19 on circulating EVs. Additionally, we found differentially expressed EV mRNA cargo in COVID-19 groups compared to Controls that regulates the differential gene expression induced by COVID-19 in the placenta. In vitro exposure of trophoblasts to EVs isolated from patients with an active infection, but not EVs isolated from Controls, reduced key trophoblast functions including hormone production and invasion. This demonstrates circulating EVs from subjects with an active infection disrupt vital trophoblast function. This study determined that COVID-19 has a long-lasting effect on circulating EVs and circulating EVs are likely to participate in the placental dysfunction induced by COVID-19.


Asunto(s)
COVID-19 , Infecciones por Coronavirus , Enfermedades Placentarias
18.
researchsquare; 2024.
Preprint en Inglés | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-3970345.v1

RESUMEN

Purpose The study aimed to investigate the potential influence of COVID-19 infection on embryo implantation and early development in women undergoing frozen embryo transfer(FET), with a specific focus on infections occurring at different periods around FET.Methods A retrospective analysis was performed on women who had undergone FET during a period marked by a significant surge in COVID-19 infection in Shanghai. All enrolled women experienced their first documented COVID-19 infection around the time of FET, ensuring that infections did not occur prior to oocyte retrieval. Participants were categorized into six groups based on the timing of infection: uninfected, ≥ 60 days, < 60 days before FET, 0–14 days, 15–28 days, and 28–70 days after FET. Clinical outcomes were compared across these groups.Results The infection rate among the total of 709 cases was 78.28%. Infected individuals exhibited either asymptomatic or mild symptoms. The ongoing pregnancy rates for the first four groups were 40.7%, 44.4%, 40.5%, and 34.2% (P = 0.709) respectively, biochemical pregnancy rates (59.1% vs. 61.1% vs. 67.6% vs. 55.7%, P = 0.471) and clinical pregnancy rates (49.6% vs. 55.6% vs. 55.4% vs. 48.1%, P = 0.749), all showed no significant differences. Early spontaneous abortion rates across all six groups were 18.3%, 20.0%, 25.0%, 28.9%, 5.4%, and 19.0% respectively, with no significant differences (P = 0.113). Multivariable logistic analysis revealed no significant correlation between the infection and ongoing pregnancy.Conclusion Asymptomatic or mild COVID-19 infections occurring around FET do not appear to have a significant adverse impact on early pregnancy outcomes.


Asunto(s)
COVID-19
19.
ClinicalTrials.gov; 18/02/2024; TrialID: NCT06272253
Clinical Trial Register | ICTRP | ID: ictrp-NCT06272253

RESUMEN

Condition:

COVID-19 Pandemic;COVID-19 Vaccines

Intervention:

Biological: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 µg

Primary outcome:

Humoral Immune Response (Neutralizing antibody)

Criteria:


Inclusion Criteria:

1. Healthy males and females, adolescents age 12-17 years old. Healthy status will be
determined by the investigator based on medical history, clinical laboratory results,
vital sign measurements, and physical examination at screening.

2. Subjects already received 2 (two) doses of Coronavac (Sinovac) vaccines at least 3
months prior to this study.

3. Subjects and the parents or guardian have been informed properly regarding the study
and signed the informed consent form

4. Subject and the parents or guardian will commit to comply with the instructions of the
investigator and the schedule of the trial

5. Participants agree not to donate bone marrow, blood, and blood products from the first
study vaccine administration until 3 months after receiving the vaccine.

6. Participants and the parents or guardian must be willing to provide verifiable
identification, has means to be contacted and to contact the investigator during the
study.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial

2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever
(axillary temperature 37.5oC or more) concurrent or within 7 days prior to study
vaccination. This includes respiratory or constitutional symptms consistent with
SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)

3. Known history of allergy to any component of the vaccines

4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular
injection

5. Any autoimmune or immunodeficiency disease/condition

6. Subjects who have received in the previous 4 weeks a treatment likely to alter the
immune response (intravenous immunoglobulin, blood derived products, long term
corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for
immunosuppressive treatment within 6 months after last vaccination. The use of topical
or nasal steroid will be permitted. Inhaled glucocorticoids are prohibited.

7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart
failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes
requiring use of medicine. The final decision regarding this condition will be decided
by the attending field clinicians or investigator.

8. Any abnormality or chronic disease which according to the investigator might interfere
with the assessment of the trial objectives

9. Subjects already immunized with any other vaccines within 4 weeks prior and expect to
receive other vaccines within 60 days following the first dose

10. Individuals who have a previously ascertained Covid-19 in the period of 1 month (for
mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the
first recruit of this study, or in a close contact in the last 14 days with confirmed
case of Covid-19.

11. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to the vaccination.
Testing may be repeated during the screening period if exposure to positive confirmed
case of SARS-CoV-2 is suspected, at the discretion of investigator.

12. History of alcohol or substance abuse

13. HIV patients.

14. Malignancy patients within 3 years prior to study vaccination.

15. Any neurological disease or history of significant neurological disorder such as
meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc

16. Vital sign abnormalities and clinical laboratory abnormalities as decided by the
investigators. Vital sign measurements and clinical laboratory testing may be repeated
before the final decision.

17. Women who are pregnant or who plan to become pregnant during the study.

18. Participant has major psychiatric problem or illness

19. Participant cannot communicate reliably with the investigator

20. Participant has contraindication to intramuscular injection and blood draws, such as
bleeding disorders or phobia.

21. Participant had major surgery within 12 weeks before vaccination which will not be
fully recovered, or has major surgery planned during the time participant is expected
to participate in the study or within 6 months after the vaccination.

22. Any condition that in the opinion of the investigators would pose a health risk to the
subject if enrolled or could interfere with the evaluation of the vaccine or
interpretation of the study results

23. Study team members.

24. Subject planning to move from the study area before the end of study period.


20.
ChiCTR; 2024-02-18; TrialID: ChiCTR2400080912
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400080912

RESUMEN

Condition:

type 2 diabetes

Intervention:

the control group:Traditional Chinese Medicine Treatment;

Primary outcome:

fasting blood glucose;2-hour postprandial blood glucose;glycated hemoglobin;standard deviation of blood glucose;mean amplitude of glycemic excursions;maximum blood glucose fluctuation amplitude;average absolute difference of daytime blood glucose;coefficient of variation;time in range of blood glucose;time above range of blood glucose;time below range of blood glucose;

Criteria:

Inclusion criteria: ? According to the T2DM criteria defined in the Guideline for the Prevention and Treatment of Type 2 diabetes mellitus in China (2020 edition);
? According to the syndrome of Damp-heat trapping the spleen in the Guidelines for Integrated Diagnosis and Treatment of Type 2 Diabetes Mellitus (2020 Edition) and the Guidelines for Clinical Diagnosis and Treatment of Diabetes Mellitus in Traditional Chinese Medicine (2020 Edition);
? The course of the disease is = 12 months;
? The age of patients were between 18 and 65, regardless of gender;
? Overweight and obese, BMI = 24kg/m2, defined by Chinese criteria29; ?no COVID-19 infections in the last 6 months, 48 hours negative for novel coronavirus-N gene test and negative for novel coronavirus-ORF1ab gene test.

Exclusion criteria: ? Failure to meet the new diagnosis of T2DM;
? Women who are pregnant or breastfeeding;
? Those with severe heart, lung, brain, liver and kidney diseases;
? Combination of any diabetic comorbidities and complications of diabetes mellitus;
? Allergy or intolerance to therapeutic drugs;
? Severe mental disorders, hysteria and inability to communicate properly;
? Other diseases that may have an effect on glucose metabolism;
? Experience of a critical illness or other stressful situation within the last month;
? Participation in other studies within the last 3 months;
? COVID-19 infection in the last 6 months, or 48 hours positive for novel coronavirus-N gene and positive for novel coronavirus-ORF1ab gene.

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