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OBJECTIVE: The purposes of the study were to develop reference ranges and maturation patterns of fetal cardiac function parameters measured by speckle tracking echocardiography (STE) using multiple biometric variables at 17 to 24 weeks' gestation among Thai fetuses and to compare with other previous reports. STUDY DESIGN: The four-chamber view of the fetal heart in 79 healthy fetuses was suitably analyzed by STE to establish the best-fit regression model. The 95% reference intervals and Z-score equations of fetal cardiac function parameters were computed. RESULTS: The fractional area change of both ventricles, left ventricular (LV) end-diastolic and end-systolic volumes, LV stroke volume, LV cardiac output (CO), and LV CO per kilogram were all increased according to gestational age (GA) and five fetal biometric measurements. However, the global longitudinal strain, basal-apical length fractional shortening (BAL-FS), BAL annular free wall and septal wall FS, BAL free wall and septal wall annular plane systolic excursions, 24-segment transverse width FS, as well as LV ejection fraction were all independent of GA or other somatic characteristics. There were varying development patterns between fetal right and left ventricles of these cardiac function indices across the gestation period. CONCLUSION: Our study created Z-score and corresponding centile calculators, 5th and 95th centile reference tables, and corresponding graphs and determined the normal evolution across gestation using multiple somatic growth and age variables between 17 and 24 gestational weeks. These nomograms serve as an essential prerequisite for quantitatively evaluating fetal cardiac contractility and allow for precisely detecting early changes in the fetal heart function. KEY POINTS: · Most fetal cardiac function measurements were correlated with all the independent variables.. · Fetal ventricular function parameters have their own characteristic maturation changes.. · Racial variability may not occupy an important place for fetal myocardial function during these GA..
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OBJECTIVES: To identify the prenatal predisposing factors related to neonatal lupus erythematosus (NLE). MATERIALS AND METHODS: A retrospective case-control study was made of 131 pregnant women with positive anti-Ro or anti-La autoantibodies and known neonatal outcomes between January 2002 and December 2019 at Siriraj Hospital, Bangkok, Thailand. There were 101 unaffected neonates and 30 NLE cases confirmed postnatally. Demographic and clinical data of the mothers and neonates with and without NLE were statistically compared. RESULTS: NLE was diagnosed in 30 out of 131 cases. A multivariate analysis identified the following significant factors for NLE: maternal anti-La antibodies (odds ratio (OR), 3.591; p = 0.030); and maternal treatment with either hydroxychloroquine (OR, 0.082; p = 0.001) or prednisolone (OR, 0.136; p = 0.017). Of the significant variables examined in the multivariate analysis models, high levels of maternal anti-La antibodies were found to be the strongest predictor of noncardiac NLE (OR, 4.558; p = 0.032), while a female baby was significantly higher in pregnancies complicated by cardiac NLE (OR, 5.374; p = 0.046). Hydroxychloroquine still provided a protective effect for both cardiac and noncardiac NLE (p = 0.039 and 0.032, respectively). CONCLUSIONS: The maternal anti-La antibodies were a beneficial predictor for NLE, especially as their high titers were influentially associated with noncardiac features. A female fetus seemed to present an increased risk for developing a congenital heart block. Nevertheless, the treatment with hydroxychloroquine during the pregnancies demonstrated a potentially protective factor against both cardiac and noncardiac manifestations.
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Lúpus Eritematoso Sistêmico , Anticorpos Antinucleares/imunologia , Estudos de Casos e Controles , Causalidade , Feminino , Humanos , Hidroxicloroquina/uso terapêutico , Lactente , Recém-Nascido , Lúpus Eritematoso Sistêmico/congênito , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Lúpus Eritematoso Sistêmico/epidemiologia , Gravidez , Estudos Retrospectivos , TailândiaRESUMO
INTRODUCTION: The aim of the study was to establish normal reference values obtained by fetal speckle tracking analysis of the fetal heart between 17 and 24 weeks of gestation among Thai fetuses and compare the nomograms with previous studies. METHODS: The 4-chamber view (4CV) of the fetal heart in 79 normal fetuses was analyzed by speckle tracking analysis to determine the best-fit regression model. The 95% reference intervals and Z-score equations of fetal cardiac parameters were computed. RESULTS: The end-diastolic length, width, area, and circumference of the 4CV as well as the ventricular end-diastolic length, 24-segment widths, and area were all increased as a function of gestational age (GA), and 5 fetal biometric parameters. In contrast, the global sphericity index (SI), 24-segment SI, and right ventricle/left ventricle width and area ratios did not change with GA or fetal biometric measurements. There were few differences in Z-score reference ranges of fetal cardiac measurements between the current study and previous studies conducted in different patient populations. CONCLUSION: Our study provided z-score and corresponding centile calculators, 5th and 95th centile reference tables, and corresponding graphs for evaluating the size and shape of the 4CV and the right and left ventricles using 6 independent variables between 17 and 24 weeks of gestation. These results provide normal reference ranges for future studies of fetuses with pathologies that may alter the size and shape of the 4CV and ventricles.
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Ventrículos do Coração , Ultrassonografia Pré-Natal , Diástole , Feminino , Coração Fetal/diagnóstico por imagem , Idade Gestacional , Ventrículos do Coração/diagnóstico por imagem , Humanos , Gravidez , Valores de Referência , Ultrassonografia Pré-Natal/métodosRESUMO
OBJECTIVE: To create nomograms for fetal cardiothoracic (CT) ratio as assessed by three different 2-dimensional sonographic measurements, including CT diameter, circumference, and area ratios, in Thai fetuses with a gestational age (GA) of 17-37 weeks, and to evaluate both their correlation with GA or biparietal diameter (BPD) and variability among the three measurement methods. METHODS: Two-dimensional sonographic measurements of fetal CT ratio in 4-chamber view were assessed by three different measurement techniques. The 95% reference intervals and Z-scores of all measurement methods based on GA or BPD were constructed. Intraclass correlation coefficients (ICC) for the reproducibility of each technique were compared. RESULTS: A total of 511 uncomplicated singleton pregnancies were included. The fetal CT ratio values by all measurement techniques gradually and smoothly increased with increasing GA and BPD. The fetal CT circumference ratio showed the least correlation with both GA and BPD. The intraobserver and interobserver reliability coefficients of all techniques demonstrated almost excellent agreement (all ICCs at least 0.87). CONCLUSION: Reference intervals and Z-score reference ranges were developed using three different techniques for fetal CT ratio with a GA of 17-37 weeks. These nomograms are a simple and reliable screening tool for identifying abnormal fetal heart size.
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Coração Fetal/diagnóstico por imagem , Idade Gestacional , Nomogramas , Pesos e Medidas/normas , Adulto , Feminino , Coração Fetal/fisiopatologia , Humanos , Gravidez , Reprodutibilidade dos Testes , Ultrassonografia Pré-Natal/métodos , Ultrassonografia Pré-Natal/estatística & dados numéricos , Pesos e Medidas/instrumentaçãoRESUMO
PURPOSE: To identify patient perspectives of barriers to cervical length screening to prevent preterm births. METHODS: In Phase I of this prospective descriptive implementation study, 40 pregnant women of up to 24 week gestation were interviewed. Phase II comprised questionnaire development and data validation. The questionnaire was subsequently administered to 400 participants in Phase III. RESULTS: Most participants (74.3%) realised preterm babies have complications and high care costs (53%). They recognised that premature-birth risk identification enables appropriate pregnancy care (93.8%), but they were unaware that cervical length measurements indicate the risk (59.5%). The participants who were aware wanted to be examined (63.5%) because of concern about preterm birth (95.8%). Husbands were reported to influence decision-making about screening (81.3%) and subsequent treatment (42.5%). If the associated costs were subsidised, the majority of participants (67.3%) would undergo screening. CONCLUSION: Physicians do not explain ways to prevent preterm births. Government policy on preventing preterm births is not well established. Screening and treatment costs are major barriers. TRIAL REGISTRATION: Thai Clinical Trials Registry (TCTR) number: TCTR20190813003.
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Medida do Comprimento Cervical/métodos , Colo do Útero/diagnóstico por imagem , Nascimento Prematuro/prevenção & controle , Adolescente , Adulto , Idoso , Feminino , Humanos , Ciência da Implementação , Recém-Nascido , Pessoa de Meia-Idade , Gravidez , Estudos Prospectivos , Centros de Atenção Terciária , Tailândia , Adulto JovemRESUMO
The objective of the study was to compare maternal and neonatal adverse outcomes between elective caesarean section (ElCS) and emergency caesarean section (EmCS) for singleton-term breech presentation. This study included women with singleton breech presentation who underwent ElCS or EmCS at term during 2007-2015 at Siriraj Hospital (Thailand). Complete data were collected for 2178 pregnant women. Of those, 1322 (60.7%) women underwent EmCS, and 856 (39.3%) delivered by ElCS. Maternal and perinatal morbidity were compared. There was no maternal or perinatal death in either group. Maternal morbidity was comparable between groups, except for longer hospital stay in the EmCS group (p = .047). One-minute Apgar score was significantly lower in the EmCS group (p = .040). There was no significant difference in 5-min Apgar score between groups. No significant difference was observed for serious maternal and neonatal morbidity between women who underwent ElCS versus those who underwent EmCS for singleton-term breech presentation.IMPACT STATEMENTWhat is already known on this subject? Emergency caesarean section (EmCS) is generally known to be associated with a higher risk of maternal and neonatal complications than elective caesarean section (ElCS).What do the results of this study add? In singleton-term breech presentation, EmCS in tertiary care setting was not associated with an increase in serious maternal and neonatal morbidity compared with EICS. Cord prolapse as an indication for emergency caesarean section was significantly associated with adverse outcomes while advanced cervical dilation ≥7 cm or low foetal station ≥+1 did not have an impact on maternal and neonatal complications.What are the implications of these findings for clinical practice and/or further research? Mean gestational age in both the ElCS and EmCS groups was approximately 38 weeks and 5 d; there were no neonatal cases with respiratory distress syndrome. Our findings suggest further prospective study in planned caesarean section scheduled for 38-39 weeks in patients with term breech presentation. The results of such a study could yield lower rates of both EmCS and potential adverse outcomes.
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Apresentação Pélvica , Cesárea , Procedimentos Cirúrgicos Eletivos , Serviços Médicos de Emergência , Complicações do Trabalho de Parto , Nascimento a Termo , Adulto , Índice de Apgar , Apresentação Pélvica/diagnóstico , Apresentação Pélvica/epidemiologia , Apresentação Pélvica/cirurgia , Cesárea/efeitos adversos , Cesárea/métodos , Cesárea/estatística & dados numéricos , Procedimentos Cirúrgicos Eletivos/métodos , Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Serviços Médicos de Emergência/métodos , Serviços Médicos de Emergência/estatística & dados numéricos , Feminino , Humanos , Recém-Nascido , Tempo de Internação/estatística & dados numéricos , Complicações do Trabalho de Parto/epidemiologia , Complicações do Trabalho de Parto/etiologia , Gravidez , Resultado da Gravidez/epidemiologia , Tailândia/epidemiologiaRESUMO
OBJECTIVE: To establish nomograms for fetal atrioventricular (AV) time intervals assessed by 3 different pulsed-wave Doppler techniques: left ventricular inflow and outflow tracts (LV in/out), superior vena cava and ascending aorta (SVC/AA), and pulmonary artery and pulmonary vein (PA/PV). METHODS: A cross-sectional study was performed in 311 normal fetuses divided into 5 groups between 16 and 38 weeks. Pulsed-wave Doppler-derived AV intervals were measured by interrogation of flow in LV in/out, SVC/AA, and PA/PV. Linear regression analyses were performed to examine correlations with gestational age (GA) and fetal heart rate (FHR). Intraclass correlation coefficients for reproducibility of each method were compared. RESULTS: Pulmonary artery and pulmonary vein revealed the longest mean AV time intervals (P < .001). The AV intervals in all methods were positively correlated with GA (R2 = 0.20-0.36; P < .001) and negatively correlated with FHR (R2 = 0.09-0.19; P < .001). The SCV/AA time intervals demonstrated the weakest influence of FHR. For LV in/out, SVC/AA, and PA/PV, intraobserver and interobserver reliability coefficients showed excellent agreements (all intraclass correlation coefficients ≥ 0.80). CONCLUSION: All pulsed-wave Doppler-derived AV time intervals increased with advancing GA and decreased with increasing FHR. Fetal AV interval measurements can be obtained in a clinically viable fashion with excellent reproducibility.
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Coração Fetal/diagnóstico por imagem , Bloqueio Cardíaco/congênito , Estudos Transversais , Ecocardiografia Doppler , Feminino , Bloqueio Cardíaco/diagnóstico por imagem , Humanos , Nomogramas , Gravidez , Estudos Prospectivos , Valores de Referência , Ultrassonografia Pré-NatalRESUMO
OBJECTIVES: To identify practical prenatal sonographic markers for the postnatal diagnosis of coarctation of the aorta. METHODS: We reviewed the fetal echocardiograms and postnatal outcomes of fetal cases of suspected coarctation of the aorta seen at a single institution between 2010 and 2014. True- and false-positive cases were compared. Logistic regression analysis was used to determine echocardiographic predictors of coarctation of the aorta. Optimal cutoffs for these markers and a multivariable threshold scoring system were derived to discriminate fetuses with coarctation of the aorta from those without coarctation of the aorta. RESULTS: Among 35 patients with prenatal suspicion of coarctation of the aorta, the diagnosis was confirmed postnatally in 9 neonates (25.7% true-positive rate). Significant predictors identified from multivariate analysis were as follows: Z score for the ascending aorta diameter of -2 or less (P = < .001), Z score for the mitral valve annulus of -2 or less (P= .033), Zscore for the transverse aortic arch diameter of -2 or less (P= .028), and abnormal aortic valve morphologic features (P= .026). Among all variables studied, the ascending aortic Z score had the highest sensitivity (78%) and specificity (92%) for detection of coarctation of the aorta. A multivariable threshold scoring system identified fetuses with coarctation of the aorta with still greater sensitivity (89%) and only mildly decreased specificity (88%). CONCLUSIONS: The finding of a diminutive ascending aorta represents a powerful and practical prenatal predictor of neonatal coarctation of the aorta. A multivariable scoring system, including dimensions of the ascending and transverse aortas, mitral valve annulus, and morphologic features of the aortic valve, provides excellent sensitivity and specificity. The use of these practical sonographic markers may improve prenatal detection of coarctation of the aorta.
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Coartação Aórtica/diagnóstico por imagem , Ecocardiografia/métodos , Ultrassonografia Pré-Natal/métodos , Aorta/diagnóstico por imagem , Aorta/embriologia , Coartação Aórtica/embriologia , Feminino , Humanos , Recém-Nascido , Valor Preditivo dos Testes , Gravidez , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
To assess the diagnostic performance of three cardiothoracic (CT) ratio techniques, including diameter, circumference, and area, for predicting hemoglobin (Hb) Bart's disease between 17 and 22 weeks' gestation, and to create a multivariable scoring system using multiple ultrasound markers. Before invasive testing, three CT ratio techniques and other ultrasound markers were obtained in 151 singleton pregnancies at risk of Hb Bart's disease. CT diameter ratio demonstrated the highest sensitivity among the other techniques. Significant predictors included CT diameter ratio > 0.5, middle cerebral artery-peak systolic velocity (MCA-PSV) > 1.5 multiples of the median, and placental thickness > 3 cm. MCA-PSV exhibited the highest sensitivity (97.8%) in predicting affected fetuses. A multivariable scoring achieved excellent sensitivity (100%) and specificity (84.9%) for disease prediction. CT diameter ratio exhibited slightly outperforming the other techniques. Increased MCA-PSV was the most valuable ultrasound marker. Multivariable scoring surpassed single-parameter analysis in predictive capabilities.
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Hemoglobinas Anormais , Talassemia alfa , Gravidez , Feminino , Humanos , Hidropisia Fetal , Placenta/diagnóstico por imagem , Ultrassonografia Pré-Natal/métodos , Talassemia alfa/diagnóstico , BiomarcadoresRESUMO
To identify pregnant women's attitudes towards, and acceptance and rejection of, COVID-19 vaccination. This prospective, descriptive, implementation study was conducted in the Antenatal clinic of Siriraj Hospital, Bangkok, Thailand. In Phase I, 40 pregnant women were interviewed. Phase II consisted of questionnaire development and data validation. In Phase III, the questionnaire was administered to 400 participants. Pregnant women's attitudes towards and acceptance and rejection of COVID-19 vaccination. Most pregnant women were uncertain about the potential harm of vaccination to themselves or their unborn child, including risks such as miscarriage or premature birth (59-66/101 [58.4%-65.3%]; OR 2.53-8.33; 95% CI 1.23-3.60, 5.17-19.30; P < 0.001) compared to those who disagreed with vaccination. Their vaccination decisions were significantly influenced by social media information regarding vaccination complications in pregnant women (74/101 [73.3%]; OR 15.95; 95% CI 2.15-118.55; P = 0.001) compared to those who disagreed with vaccination. Most pregnant women opined that they should not receive a COVID-19 vaccination during pregnancy (adjusted odds ratio [AOR] 6.57; 95% CI 2.44-17.70; P = 0.001). Most also rejected vaccination despite being aware of its benefits (AOR 17.14; 95% CI 6.89-42.62; P < 0.001). Social media messages and obligatory vaccination certifications influence maternal vaccination decisions. Pregnant women believe vaccination helps prevent COVID-19 infection and reduces its severity. Nevertheless, the primary reason for their refusal was concern about potential harm to their unborn child or themselves during pregnancy.The Thai clinical trials registry: TCTR20211126006.
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Aborto Espontâneo , COVID-19 , Feminino , Gravidez , Humanos , Gestantes , Tailândia , Vacinas contra COVID-19/efeitos adversos , Estudos Prospectivos , Aceitação pelo Paciente de Cuidados de Saúde , Conhecimentos, Atitudes e Prática em Saúde , COVID-19/prevenção & controle , Inquéritos e Questionários , VacinaçãoRESUMO
INTRODUCTION: Recombinant acellular pertussis (ap) vaccines containing genetically inactivated pertussis toxin (PTgen) and filamentous hemagglutinin (FHA) with or without tetanus (TT) and diphtheria (DT) vaccines (Td) were found safe and immunogenic in non-pregnant and pregnant women. We report here maternal antibody transfer and safety data in mothers and neonates. METHODS: This is the follow up of a phase 2 trial in 2019 among 400 pregnant women who randomly received one dose of recombinant pertussis-only vaccine containing 1 µg PTgen and 1 µg FHA (ap1gen), or Td combined with ap1gen (Tdap1gen), or with 2 µg PTgen and 5 µg FHA (Tdap2gen), or with 5 µg PTgen and 5 µg FHA (TdaP5gen, Boostagen®, BioNet, Thailand) or chemically-inactivated acellular pertussis comparator (Tdap8chem, Boostrix™, GSK, Belgium), either in the second or third trimester of gestation. IgG against PT, FHA, TT and DT were assessed by ELISA, PT-neutralizing antibodies (PTNA) by Chinese Hamster Ovary cell assay and safety outcomes at delivery in mothers and at birth. RESULTS: Anti-PT and anti-FHA geometric mean concentration (GMC) ratio between infants at birth and mothers at delivery was above 1 in all groups. PT GMC in infants at birth were ≥30 IU/mL in all groups with the highest titers in infants found in TdaP5gen group at birth (118.8 [95% CI 93.9-150.4]). At 2 months, PT GMC ratio to Tdap8chem (98.75% CI) was significantly higher for TdaP5gen (2.6 [1.7-4.0]) and comparable for other recombinant vaccines. No difference in PTNA titers at birth was observed between all groups nor between time of vaccination. Adverse events were comparable in all vaccine groups. CONCLUSIONS: BioNet licensed (TdaP5gen and Tdap2gen) and candidate vaccines (Tdap1gen and ap1gen) when given to pregnant women in the second or third trimester of gestation are safe and have induced passive pertussis immunity to infants.
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Vacinas contra Difteria, Tétano e Coqueluche Acelular , Tétano , Coqueluche , Lactente , Recém-Nascido , Cricetinae , Animais , Humanos , Feminino , Gravidez , Coqueluche/prevenção & controle , Células CHO , Anticorpos Antibacterianos , Cricetulus , Vacina contra Coqueluche , Vacinação , Vacinas Sintéticas , Toxoide Tetânico , Anticorpos Neutralizantes , Mães , Período Pós-PartoRESUMO
Fetal onset of congenital long QT syndrome (LQTS) is a rare manifestation, and prenatal diagnosis is difficult. This report describes a boy who presented with both atrioventricular (AV) block and ventricular tachycardia during the antenatal period. The early postnatal electrocardiogram showed prolongation of the QT interval and AV block, subsequently leading to a polymorphic ventricular tachycardia torsade de pointes. This unique feature of congenital LQTS has a poor outcome, but the boy was successfully treated with beta-blockers and implantation of an automated cardioverter-defibrillator. The intrauterine manifestation of fetal AV block and ventricular tachycardia should raise a high suspicion of congenital LQTS, and the strong association with a malignant clinical course should warrant special evaluation. The literature on the prenatal diagnosis, fetal therapy, and neonatal outcome of this condition also are reviewed.
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Bloqueio Atrioventricular/etiologia , Síndrome do QT Longo/embriologia , Taquicardia Ventricular/embriologia , Adolescente , Bloqueio Atrioventricular/diagnóstico , Bloqueio Atrioventricular/embriologia , Diagnóstico Diferencial , Eletrocardiografia , Feminino , Humanos , Recém-Nascido , Síndrome do QT Longo/complicações , Síndrome do QT Longo/diagnóstico , Masculino , Gravidez , Diagnóstico Pré-Natal , Taquicardia Ventricular/complicações , Taquicardia Ventricular/diagnósticoRESUMO
OBJECTIVE: There are few data on lactating women's concerns about receiving COVID-19 vaccination during breastfeeding. This research investigated breastfeeding women's attitudes towards and acceptance or rejection of vaccination. MATERIALS AND METHODS: This prospective, descriptive, implementation study was conducted in the postpartum ward of Siriraj Hospital, Bangkok, Thailand. In Phase I, 40 breastfeeding women in the postpartum ward at Siriraj Hospital who were willing to participate in the study were interviewed. Phase II comprised questionnaire development and data validation. The combined multiple choice and scaling questionnaires designed based on the results from comprehensive interviews of phase I were used in the study. The questionnaire was administered to 400 participants in Phase III. MAIN OUTCOME MEASURES: Breastfeeding women's attitudes towards and acceptance and rejection of COVID-19 vaccination. RESULTS: The vast majority of participants (372/400 [93.0â¯%]) were vaccinated predelivery. Most of the subgroup of women rejecting vaccination while breastfeeding were unsure whether too frequent vaccination would harm their unborn child (52/99 [52.5â¯%]; crude odds ratio [cOR], 6.50; 95â¯% CI, 1.47-28.68; Pâ¯<â¯0.001). The level of immunity to the COVID-19 virus did not influence their vaccination decisions (19/99 [19.2â¯%]; cOR, 2.38; 95â¯% CI, 1.26-4.47; Pâ¯<â¯0.001). Multivariable analysis found a significant association for women agreeing with the proposition that vaccination during pregnancy should not be performed (adjusted odds ratio [aOR], 4.83; 95â¯% CI, 1.41-16.57; Pâ¯=â¯0.043). Most women who rejected vaccination knew its benefits (aOR, 31.84; 95â¯% CI, 7.16-141.65; Pâ¯<â¯0.001). CONCLUSIONS: Breastfeeding women generally believed that vaccines reduce infection and disease severity. The women's COVID-19 immunity levels did not affect their acceptance or rejection of vaccination. Some mothers rejected vaccination because of concerns about possible harm to them or their newborns.
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Vacinas contra COVID-19 , COVID-19 , Gravidez , Feminino , Humanos , Recém-Nascido , Aleitamento Materno , Lactação , Estudos Prospectivos , Conhecimentos, Atitudes e Prática em Saúde , Aceitação pelo Paciente de Cuidados de Saúde , COVID-19/prevenção & controle , Tailândia , Inquéritos e Questionários , VacinaçãoRESUMO
OBJECTIVE: To identify physicians' views on the barriers to measuring cervical length for preventing preterm deliveries. MATERIALS AND METHODS: This prospective, descriptive implementation study had three phases. In Phase I, 20 physicians were interviewed. Phase II comprised questionnaire development and data validation. The questionnaire was distributed to 120 Phase III participants. RESULTS AND DISCUSSION: All 120 participants responded. In 44 cases, the physicians received support from their local Maternal and Child Health Boards for preterm-birth-prevention programs; the other 76 physicians did not. The doctors tended to believe that cervical length screening plays no role in preventing preterm births (4/44 (9.1%) and 24/76 (31.6%); OR, 4.615; 95% CI, 1.482-14.373; p = 0.005). They were unsure about the correct measurement procedures (13/44 (29.5%) and 37/76 (48.7%); OR, 2.262; 95% CI, 1.028-4.977; p = 0.040). A lack of cost-free drug support (progesterone) for women with short cervices was identified as a barrier to preventing preterm births (30/44 (68.2%) and 32/76 (42.1%); OR, 0.339; 95% CI, 0.155-0.741; p = 0.006). CONCLUSIONS: Many physicians are unconvinced that measuring cervical length prevents premature births, and are unsure about the correct measurement procedures. There is a lack of government funding for hormone-usage programs.
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This open-labeled non-inferiority trial evaluated immunogenicity and reactogenicity of heterologous and homologous COVID-19 vaccination schedules in pregnant Thai women. 18-45-year-old pregnant women with no history of COVID-19 infection or vaccination and a gestational age of ≥12 weeks were randomized 1:1:1 into three two-dose primary series scheduled 4 weeks apart: BNT162b2-BNT162b2 (Group 1), ChAdOx1-BNT162b2 (Group 2), and CoronaVac-BNT162b2 (Group 3). Serum antibody responses, maternal and cord blood antibody levels at delivery, and adverse events (AEs) following vaccination until delivery were assessed. The 124 enrolled participants had a median age of 31 (interquartile range [IQR] 26.0-35.5) years and gestational age of 23.5 (IQR 18.0-30.0) weeks. No significant difference in anti-receptor binding domain (RBD) IgG were observed across arms at 2 weeks after the second dose. Neutralizing antibody geometric mean titers against the ancestral Wuhan strain were highest in Group 3 (258.22, 95% CI [187.53, 355.56]), followed by Groups 1 (187.47, 95% CI [135.15, 260.03]) and 2 (166.63, 95% CI [124.60, 222.84]). Cord blood anti-RBD IgG was correlated with, and equal to or higher than, maternal levels at delivery (r = 0.719, P < .001) and inversely correlated with elapsed time after the second vaccination (r = -0.366, P < .001). No significant difference in cord blood antibody levels between groups were observed. Local and systemic AEs were mild-to-moderate and more frequent in Group 2. Heterologous schedules of CoronaVac-BNT162b2 or ChAdOx1-BNT162b2 induced immunogenicity on-par with BNT162b2-BNT162b2 and may be considered as alternative schedules for primary series in pregnant women in mRNA-limited vaccine settings.
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Vacinas contra COVID-19 , COVID-19 , Complicações Infecciosas na Gravidez , Adolescente , Adulto , Feminino , Humanos , Lactente , Pessoa de Meia-Idade , Gravidez , Adulto Jovem , Anticorpos Antivirais , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Imunogenicidade da Vacina , Imunoglobulina G , Complicações Infecciosas na Gravidez/prevenção & controle , Gestantes , VacinaçãoRESUMO
INTRODUCTION: Despite a decrease in infections caused by Bordetella pertussis due to COVID-19 pandemic, booster vaccination of pregnant women is still recommended to protect newborns. Highly immunogenic vaccines containing genetically inactivated pertussis toxin (PTgen) and filamentous hemagglutinin (FHA) may generate comparable anti-PT antibody concentrations, even at lower doses, to chemically inactivated acellular pertussis vaccines (Tdapchem) shown effective for maternal immunization. METHODS: This phase 2 randomized, observer-blind, active-controlled non-inferiority trial was conducted in healthy Thai pregnant women randomly assigned to receive one dose of low-dose recombinant pertussis-only vaccine containing 1 µg PTgen and 1 µg FHA (ap1gen), or tetanus, reduced-dose diphtheria combined with ap1gen (Tdap1gen), or combined with 2 µg PTgen and 5 µg FHA (Tdap2gen), or with 5 µg PTgen and 5 µg FHA (TdaP5gen, Boostagen®) or comparator containing 8 µg of chemically inactivated pertussis toxoid, 8 µg FHA, and 2.5 µg pertactin (Boostrix™, Tdap8chem). Blood was collected at Day 0 and Day 28 post-vaccination. The non-inferiority of the study vaccines was assessed based on anti-PT IgG antibody levels on Day 28 pooled with results from a similarly structured previous trial in non-pregnant women. RESULTS: 400 healthy pregnant women received one dose of vaccine. Combined with data from 250 non-pregnant women, all study vaccines containing PTgen were non-inferior to comparator vaccine (Tdap8chem). Both ap1gen and TdaP5gen vaccines could be considered to have superior immunogenicity to Tdap8chem. Local and systemic solicited reactions were similar among all vaccine groups. CONCLUSIONS: Vaccine formulations containing PTgen were safe and immunogenic in pregnant women. The ap1gen vaccine, with the lowest cost and reactogenicity, may be suitable for use in pregnant women when diphtheria and tetanus toxoids are not needed. This study is registered in the Thai Clinical Trial Registry (www. CLINICALTRIALS: in.th), number TCTR20180725004.
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COVID-19 , Vacinas contra Difteria, Tétano e Coqueluche Acelular , Difteria , Tétano , Coqueluche , Recém-Nascido , Humanos , Feminino , Toxina Pertussis/genética , Pandemias , Vacina contra Coqueluche , Imunização Secundária/métodos , Toxoide Tetânico , Vacinas Sintéticas , Anticorpos Antibacterianos , Vacina contra Difteria, Tétano e CoquelucheRESUMO
[This corrects the article DOI: 10.1371/journal.pone.0257205.].
Assuntos
Anormalidades Múltiplas/diagnóstico por imagem , Aorta Torácica/anormalidades , Aorta Torácica/diagnóstico por imagem , Transposição dos Grandes Vasos/diagnóstico por imagem , Ultrassonografia Pré-Natal/métodos , Adulto , Aorta Torácica/embriologia , Diagnóstico Diferencial , Feminino , Humanos , Masculino , GravidezRESUMO
BACKGROUND: Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) has recently been implemented to prevent infant pertussis. Tdap is still not routinely recommended in Thailand, and there are limited data to support or challenge this strategy. OBJECTIVES: The primary aim was to determine the seroprevalence of anti-pertussis toxin antibodies (anti-PT IgG) among pregnant Thai women. The secondary aims were to evaluate antibodies response after Tdap vaccination between seronegative and seropositive mothers and to compare the different antibody titers at delivery among seropositive mothers who received Tdap to those who received tetanus-diphtheria vaccine (Td). METHODS: This randomized clinical trial was conducted during April 2018 to April 2019 at Siriraj Hospital, Bangkok, Thailand. A total of 129 pregnant women were included. Paired blood samples for anti-PT IgG levels were obtained during the first antenatal visit and at delivery. A baseline cut-off value of <5 IU/ml indicated seronegativity. There were 29 exclusions from the original 129 enrollment. All seronegative participants (n = 69) received Tdap, while the seropositive group were randomized 1:1 to receive either Tdap (n = 18) or Td (n = 13) during 27-36 weeks' gestation. The antibody levels from both sera were compared between groups. RESULTS: The seroprevalence of maternal anti-PT IgG was 33.3% (43/129). There was no significant difference in the increment of antibody levels after Tdap vaccination between the seronegative and seropositive groups (30.2 vs. 42 IU/ml; p = 0.183). Among seropositive groups, all Tdap recipients had increased antibody titers at delivery, while all Td recipients showed waning of immunity throughout gestation. (42 IU/ml vs. -7.4 IU/ml; p < 0.001). CONCLUSION: Most pregnant Thai women have seronegative against pertussis. Most seropositive mothers had initial low antibody titers and their immunity significantly decreased before delivery. Our findings highlight the need for universal pertussis immunization in pregnancy regardless of individual baseline immunity.