scholarly journals Study protocol of the PIMPI-project, a cohort study on acceptance, tolerability and immunogenicity of second trimester maternal pertussis immunization in relation to term and preterm infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maarten M. Immink ◽  
Mireille N. Bekker ◽  
Hester E. de Melker ◽  
Nynke Y. Rots ◽  
Elisabeth A. M. Sanders ◽  
...  

Abstract Background Maternal immunization confers passive immunity to the fetus by transplacental antibody transfer. Infants may be better protected against pertussis if the mother received a diphtheriae, tetanus and acellular pertussis (Tdap) vaccination in the second trimester of pregnancy compared to the third trimester. This study evaluates IgG antibody concentrations in term and preterm infants at birth and 2 months after birth after maternal Tdap-vaccination between 200 and 240 w of gestation vs third trimester Tdap-vaccination. Further aims are assessing the determinants that underlie acceptance of second trimester maternal Tdap-vaccination as well as the tolerability of vaccination. Methods This prospective cohort study consists of two parts. In the acceptance part, pregnant women complete a questionnaire on determinants that underlie acceptance of a second trimester Tdap-vaccination, which is offered subsequently between 200 and 240 w of gestation. Vaccinated women complete an additional questionnaire on vaccination tolerability. Vaccinated women may also participate in the immunogenicity part, in which blood is drawn from mother at delivery and from infant at birth and 2 months after birth. Women are also eligible for the immunogenicity part if they received a Tdap-vaccination between 200 and 240 w of gestation via the national immunization program and get hospitalized for an imminent preterm delivery. Blood sampling continues until 60 term and 60 preterm mother-infant-pairs have been included. Pertussis-specific IgG antibody concentrations are determined in serum using a fluorescent bead-based multiplex immunoassay. For term infants, non-inferiority in IgG antibody concentrations against pertussis toxin (anti-PT) will be assessed referred to a historical control group in which mothers were Tdap-vaccinated between 300 and 320 w of gestation. For preterm infants, non-inferiority of anti-PT IgG concentrations is referred to as 85% of infants having ≥ 20 international units/mL at 2 months after birth. Discussion This study investigates acceptance, tolerability and immunogenicity regarding maternal Tdap-immunization between 200 and 240 w of gestation. Its results provide insight into the effects of second trimester Tdap-vaccination on IgG antibody concentrations in term and preterm infants before primary infant vaccinations. Results on acceptance and tolerability guide antenatal care providers in communication with pregnant women and maintain the safety of second trimester Tdap-vaccination. Trial registration: EU Clinical Trials Register, 2018-002976-41, retrospectively registered 24 July 2019, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2018-002976-41.

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Dong Wang ◽  
Caixia Liu ◽  
Xinyu Liu ◽  
Ying Zhang ◽  
Yu Wang

Abstract Background Due to metabolic changes in the second trimester and the increasing number of pregnant women with obesity and advanced maternal age, the incidence of gestational diabetes mellitus (GDM) remains high. This study aimed to evaluate the effects of GDM on fetal cardiac morphology and function, and to determine whether these changes increase with increasing estimated fetal weight (EFW). Methods Fifty-eight women with GDM (GDM group) and 58 women with a healthy pregnancy (control group) were included in this prospective observational cohort study. Each group included subgroups of 31 pregnant women with a gestational age between 24+0 weeks and 27+6 weeks as well as 27 pregnant women with a gestational age between 28+0 weeks and 40+0 weeks. For all fetuses, a cine of 2–3 s in the four-chamber view was obtained, and online speckle-tracking analysis was performed using the GE Automatic Fetal Heart Assessment Tool (fetal HQ; General Electric Healthcare Ultrasound, Zipf, Austria) to measure the global sphericity index (GSI), global longitudinal strain (GLS), fractional area change (FAC), 24-segment sphericity index (SI), and 24-segment end-diastolic diameter of the left ventricle (LV) and right ventricle (RV). Data were analyzed using the independent t-test and Wilcoxon rank-sum test, as applicable. Results The GDM group (mean HbA1c value was 5.3 ± 0.57 mmol/L) showed a lower GSI value than the control group (1.21 vs. 1.27, P = 0.000), which indicated a rounder shape of the heart. In addition, fetuses in the GDM group demonstrated significant impairment in cardiac function compared to those in the control group (LV-GLS: -18.26% vs. -22.70%, RV-GLS: -18.52% vs. -22.74%, LV-FAC: 35.30% vs. 42.36%, RV-FAC: 30.89% vs. 36.80%; P = 0.000 for all). Subgroup analyses according to gestational age (24+0–27+6 weeks and 28+0–40+0 weeks) showed that the statistical differences were retained between the GDM and control groups in each subgroup. Conclusions Fetuses of women with GDM present with signs of biventricular systolic dysfunction according to deformation analysis using fetal HQ. Additionally, the heart had a rounder shape in the GDM group than in the control group. This study showed that fetal HQ can be used to assess fetal cardiac morphology and function easily and quickly, and the effects of GDM on fetal cardiac morphology and function appeared from the second trimester. Thus, whether earlier and stricter clinical intervention was necessary remained to be further studied. Furthermore, future studies will need to supplement the effects of blood glucose levels on GLS, FAC, GSI, and 24-segment SI. Additionally, the long-term follow-up after birth should also be improved to observe the influence of changes in the indicators on the prognosis.


2021 ◽  
Vol 8 ◽  
Author(s):  
Ting-ting Lin ◽  
Chen Zhang ◽  
Lei Chen ◽  
Li Jin ◽  
Xian-hua Lin ◽  
...  

Purpose: To estimate whether the city-specific lockdown in Shanghai induced by the COVID-19 pandemic affected preterm birth rates among uninfected pregnant women in different trimesters.Methods: The population-based retrospective cohort study was conducted in the International Peace Maternity and Child Health Hospital (IPMCH) in Shanghai, China. Pregnant women without COVID-19 received perinatal healthcare during lockdown (from January 24, 2020 to March 24, 2020) and non-lockdown (from January 24, 2019 to March 24, 2019) period and giving birth to a live infant at IPMCH were enrolled. 1:1 propensity score matching and Inverse probability of treatment weighting were used to evaluate preterm birth (<37 weeks), very preterm birth (<34 weeks), preterm birth with premature rupture of membranes (PROM-PTB), spontaneous preterm birth with intact membranes (S-PTB), and medically induced preterm birth (MI-PTB) between two groups.Results: 8,270 pregnant women were in the lockdown group, and 9,815 were in the non-lockdown group. Pregnant women in second trimester during lockdown had a higher risk of PTB than those during the non-lockdown period [OR: 1.43 (CI 1.01–2.02), ARD: 1.7% (CI 0.04–3.4%), p = 0.045]. Furthermore, pregnant women in third trimester during lockdown had a higher risk of PROM-PTB than those during the non-lockdown period [OR: 1.64 (CI 1.09–2.47), ARD: 0.9% (CI 0.2–1.6%), p = 0.02]; no group differences were found related to rates of VPTB, S-PTB or MI-PTB.Conclusion: In this cohort study in China, we found that there was an increased risk in preterm birth for non-infected women in COVID-19 lockdown who were in their second trimester.


2018 ◽  
Vol 56 (5) ◽  
pp. 803-807 ◽  
Author(s):  
Yun Hu ◽  
Yiling Ding ◽  
Mengyuan Yang ◽  
Zhongyuan Xiang

AbstractBackground:Reference intervals (RIs) play key roles in clinical diagnosis, treatment and prognosis. However, RIs for clinical testing tend to be confined to the general population, and RIs for pregnant women are not very comprehensive. In this study, we establish RIs for prolactin (PRL) in healthy pregnant and postpartum women in the Chinese population.Methods:Healthy pregnant women (n=378) were divided into groups according to whether they were in the first, second or third trimester of pregnancy. Healthy postpartum women (n=493) were separated into four groups according to mode of delivery as follows: postvaginal (24 and 48 h) or postcesarean (24 and 48 h). Healthy, non-pregnant women (n=123) were enrolled as a control group. Serum PRL levels were measured by electrochemiluminescence immunoassay, and RIs were established for each group.Results:The RIs for PRL were as follows: healthy non-pregnant women, 178.89–757.52 μIU/mL; first trimester, 621.20–3584.00 μIU/mL; second trimester, 1432.00–5349.68 μIU/mL; third trimester, 4087.33–9733.65 μIU/mL; 24 and 48 h postvaginal delivery (combined), 7865.36–10998.86 μIU/mL; and 24 and 48 h postcesarean delivery, 4556.41–7675.99 and 6578.45–9980.45 μIU/mL, respectively.Conclusions:PRL RIs for pregnant women were established according to trimester, days postpartum and mode of delivery, thus providing a clinical reference for medical staff.


2019 ◽  
Vol 9 (1) ◽  
pp. 18-22
Author(s):  
Nilima Baral ◽  
Rezwana Haque ◽  
Farzana Akonjee Mishu

Background: Preeclampsia is a fatal medical disorder of pregnancy. It has been associated with adverse course and outcome of the pregnancy resulting in increased maternal and infant mortality and morbidity. As the pathogenesis of preeclampsia is not completely understood, prevention remains a complex issue. In recent times, there has been an increasing prevalence in the incidence of preeclampsia globally. The aim of this study is to determine the states of the copper in pregnant women with preeclampsia. Methods: This case-control study was carried out in the Department of Biochemistry, Mymensingh Medical College, Mymensingh, from July 2013 to June 2014. The subjects were selected on the basis of inclusion and exclusion criteria by purposive method. This study included 73 patients with preeclampsia as case (Gr.I) classified into two subgroups according to the gestational age: Gr.I(a); preeclampsia in the second trimester (n = 35), and Gr.I(b); preeclampsia in the third trimester (n = 38). Copper levels were analyzed and results were compared with 73 apparently healthy pregnant control (Gr.II), and the corresponding gestational age subgroups [Gr.II(a); normal pregnancy of second trimester (n = 35) and Gr.II(b), normal pregnancy of third trimester (n = 38)]. Results: The mean serum copper level was significantly (p<0.001) lower in case group than that of control group. Similar extent of reduction was observed in serum copper level at different gestational age groups of preeclamptic women when compared with corresponding control groups. Conclusion: Estimation of serum copper level should be incorporated in pre eclamptic patients for prevention of complications. Birdem Med J 2019; 9(1): 18-22


Rheumatology ◽  
2021 ◽  
Author(s):  
Rugina I Neuman ◽  
Hieronymus T W Smeele ◽  
A H Jan Danser ◽  
Radboud J E M Dolhain ◽  
Willy Visser

Abstract Objectives An elevated sFlt-1/PlGF-ratio has been validated as a significant predictor of preeclampsia, but has not been established in women with rheumatoid arthritis (RA). We explored whether the sFlt-1/PlGF-ratio could be altered due to disease activity in RA, and could be applied in this population to predict preeclampsia. Since sulfasalazine has been suggested to improve the angiogenic imbalance in preeclampsia, we also aimed to examine whether sulfasalazine could affect sFlt-1 or PlGF levels. Methods Making use of a nationwide, observational, prospective cohort study on pregnant women with RA, sFlt-1 and PlGF were measured in the third trimester. A total of 221 women, aged 21–42 years, were included, with a median gestational age of 30 + 3 weeks. Results No differences in sFlt-1 or PlGF were observed between women with high, intermediate or low disease activity (p= 0.07 and p= 0.41), whereas sFlt-1 and PlGF did not correlate with DAS28-CRP score (r=-0.01 and r=-0.05, respectively). Four (2%) women with a sFlt-1/PlGF-ratio ≤38 developed preeclampsia in comparison to three (43%) women with a ratio &gt; 38, corresponding to a negative predictive value of 98.1%. Sulfasalazine users (n = 57) did not show altered levels of sFlt-1 or PlGF in comparison to non-sulfasalazine users (n = 164, p= 0.91 and p= 0.11). Conclusion Our study shows that in pregnant women with RA, the sFlt-1/PlGF-ratio is not altered due to disease activity and a cut-off ≤38 can be used to exclude preeclampsia. Additionally, sulfasalazine use did not affect sFlt-1 or PlGF levels in this population.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 235.2-235
Author(s):  
J. Y. E. Lee ◽  
A. Mendel ◽  
I. Malhamé ◽  
S. Bernatsky ◽  
E. Vinet

Background:Pregnant women with systemic lupus erythematosus (SLE) are at high risk of preeclampsia, leading to substantial maternal and fetal morbidity. Aspirin reduces preeclampsia risk but recent studies suggest aspirin is used only in a minority of SLE pregnancies. There is an urgent need to improve preeclampsia counselling and management in this vulnerable population.Objectives:We are conducting the PREPARE (PREeclamPsia knowledge & Aspirin adheRence in lupus prEgnancies) trial, a randomized controlled trial (RCT) evaluating an educational tool on preeclampsia knowledge and aspirin adherence among pregnant women with SLE. We present preliminary analyses of the effect of this tool on preeclampsia knowledge.Methods:Consecutive pregnant SLE women are recruited until the 16th gestational week at 5Canadian Systemic Lupus International Collaborating Clinics centres (i.e. Montreal, Halifax, Quebec, Winnipeg, and Calgary) since 05/2018. Subjects are randomly assigned to receive either the specifically-designed educational tool (intervention group) or standard of care (control group). At baseline (i.e. first trimester) and second trimester visits, the participants complete self-administered preeclampsia knowledge questionnaires (scored out of 30 by the research team blinded to the intervention). We restricted the current analysis to participants enrolled in Montreal (accounting for nearly half of the total planned sample size). We performed a univariate linear regression analysis to assess the effect of the educational tool on preeclampsia knowledge (i.e. mean score difference between the two groups from baseline to second trimester visit).Results:Thirty-three pregnant SLE women were included in the study, among which 16 were exposed to the intervention and 17 were unexposed. Baseline characteristics were well balanced between the two groups with similar mean maternal age between intervention group (32.2 years, standard deviation, SD, 4.6) and control group (34.1 years, SD 4.2) and identical proportion of subjects with post-secondary education (i.e. 80%). The difference in mean preeclampsia knowledge scores between second trimester and baseline visits in the intervention group was 4.4 points (95% CI -0.1, 9.0) and in the control group was 1.5 points (95% CI -2.7, 5.7). The mean difference in knowledge scores (from baseline to second trimester) for those receiving the educational tool was 2.7 points higher (95% CI -1.5, 6.9) than those receiving standard of care.Conclusion:Approximately midway into the PREPARE trial, we observed a trend for improvement in preeclampsia knowledge from the baseline to the second trimester visit in pregnant women with SLE who received a specifically-designed educational tool compared to the control group, although the CIs included the null. Our RCT is well-poised to provide a new evidence-based approach to improve preeclampsia knowledge in pregnant women with SLE, which could help to optimize aspirin use and outcomes in this vulnerable population.References:[1]Schramm AM, Clowse ME. Aspirin for prevention of preeclampsia in lupus pregnancy. Autoimmune Dis. 2014;2014:920467. doi:10.1155/2014/920467[2]Bujold E, Roberge S, Lacasse Y, et al. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis. Obstet Gynecol. 2010;116(2 Pt 1):402-414. doi:10.1097/AOG.0b013e3181e9322a[3]Andreoli L, Bertsias GK, Agmon-Levin N, et al. EULAR recommendations for women’s health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 2017 Mar;76(3):476–85. doi: 10.1136/annrheumdis-2016-209770.[4]Mendel A, Bernatsky SB, Hanly JG, et al. Low aspirin use and high prevalence of preeclampsia risk factors among pregnant women in a multinational SLE inception cohort. Ann Rheum Dis. 2019;78(7):1010-1012. doi:10.1136/annrheumdis-2018-214434Disclosure of Interests:None declared.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Najmieh Saadati ◽  
Poorandokht Afshari ◽  
Hatam Boostani ◽  
Maryam Beheshtinasab ◽  
Parvin Abedi ◽  
...  

Abstract Background The COVID-19 pandemic has affected many countries around the world and Iran was no exception. The aim of this study was to evaluate health anxiety of Iranian pregnant women during the COVID-19 pandemic. Methods In this cross-sectional study, 300 pregnant women in different trimesters (n = 100 in each trimester) were recruited. A demographic questionnaire and the Health Anxiety Questionnaire were used to collect data. Scores of < 27, 27–34 and more than 35 were defined as low, moderate and high health anxiety, respectively. Due to nationwide restrictions, data were collected through social media groups. Chi-square tests, ANOVA and multiple linear regression were used to analyze the data. Results Mean (SD) total anxiety scores were 22.3 ± 9.5, 24.6 ± 9.3 and 25.4 ± 10.6 in the first, second and third trimesters of pregnancy, respectively. 9, 13 and 21% of women had severe anxiety in the first, second and third trimesters of pregnancy, respectively. Women in the third trimester had significantly higher health anxiety scores than those in the first trimester (p = 0.045). Conclusion At the time of the COVID-19 pandemic, women in the second and third trimesters of pregnancy were more worried about consequences of disease, but total health anxiety scores were significantly higher among women in the third trimester of pregnancy. Health care providers should pay more attention to the mental health of pregnant women in times of crises such as the COVID-19 pandemic.


2021 ◽  
Author(s):  
Fatemeh Sarhaddi ◽  
Iman Azimi ◽  
Anna Axelin ◽  
Hannakaisa Niela-Vilen ◽  
Pasi Liljeberg ◽  
...  

BACKGROUND Heart rate variability (HRV) is a non-invasive method reflecting autonomic nervous system (ANS) regulations. Altered HRV is associated with adverse mental or physical health complications. ANS also has a central role in physiological adaption during pregnancy causing normal changes in HRV. OBJECTIVE Assessing trends in heart rate (HR) and HRV parameters as a non-invasive method for remote maternal health monitoring during pregnancy and three months postpartum. METHODS Fifty-eight pregnant women were monitored using an Internet-of-Things (IoT)-based remote monitoring system during pregnancy and 3-months postpartum. Pregnant women were asked to continuously wear Gear sport smartwatch to monitor their HR and HRV. In addition, a cross-platform mobile application was utilized for collecting pregnancy-related information. The trends of HR and HRV parameters were extracted using reliable data. We also analyzed the trends of normalized HRV parameters based on HR to remove the effect of HR changes on HRV trends. Finally, we exploited hierarchical linear mixed models to analyze the trends of HR, HRV, and normalized HRV parameters. RESULTS HR increased significantly during the second trimester (P<.001) and decreased significantly during the third trimester (P<.01). Time-domain HRV parameters, average normal interbeat intervals (AVNN), standard deviation of normal interbeat intervals (SDNN), root mean square of the successive difference of normal interbeat intervals (RMSSD), normalized SDNN (nSDNN), and normalized RMSSD (nRMSSD) decreased significantly during the second trimester (P<.001) then increased significantly during the third trimester (P<.01). Some of the frequency domain parameters, low-frequency power (LF), high-frequency power (HF), and normalized HF (nHF) decreased significantly during the second trimester (P<.01), and HF increased significantly during the third trimester (P<.01). In the postpartum period, nRMSSD decreased (P<.05), and the LF to HF ratio (LF/HF) increased significantly (P<.01). CONCLUSIONS Our study showed that HR increased and HRV parameters decreased as the pregnancy proceeded, and the values returned to normal after the delivery. Moreover, our results show that HR started to decrease while time-domain HRV parameters and HF started to increase during the third trimester. Our results also demonstrate the possibility of continuous HRV monitoring in everyday life settings.


2016 ◽  
Vol 10 (2) ◽  
pp. 67-70
Author(s):  
Sumaira Sufrin ◽  
Akhtarun Nessa ◽  
Md Tazul Islam

Background : Pregnancy is a state of physiological adaptations to accommodate the needs of the developing fetus. Elevated blood glucose during pregnancy could lead to gestational diabetes and anemia could cause intercurrent infection.Objective: To assess the serum glucose level & hemoglobin concentration in third trimester of pregnancy in order to find out the risk of gestational diabetes and physiological anemia.Method: This cross-sectional study was carried out in the Department of Physiology Mymensingh Medical College, Mymensingh, between the period of July, 2013 to June,2014. One hundred pregnant women in their third trimester of pregnancy aged 18-35years were enrolled in study group and age matched 100 healthy non-pregnant women were control group. Random serum glucose was estimated by GOD-PAP method and hemoglobin concentration was measured by cyanmethemoglobin (CMG) method. Data were analyzed by student’s un paired t test and chi square test.Result: Mean serum glucose level (6.76±1.72 mmol/L) was significantly higher and hemoglobin concentration (8.21±1.23 g/dl) was significantly lower in pregnant women than non-pregnant women. Increased frequency of high glucose (38%) and low H b(88%) was found in pregnant women in third trimester.Conclusion: This study concludes altered glucose metabolism may lead to gestational diabetes as well as physiological anemia may be exaggerated in third trimester of pregnancyBangladesh Soc Physiol. 2015, December; 10(2): 67-70


2021 ◽  
Author(s):  
Qin-Yu Cai ◽  
Yin Yang ◽  
Ling-Ling Ruan ◽  
Dang-Dang Wang ◽  
Han-Lin Cui ◽  
...  

Abstract Aims: This study was to evaluate the effects of the home quarantine on pregnancy outcomes of gestational diabetes mellitus (GDM) patients during the COVID-19 outbreak.Methods: Thecomplete electronic medical records of GDM patients with home quarantine history were collected and classified into the home quarantine group from 24 February 2020 to 24 November 2020. The same period of GDM patients without home quarantine historywas included in the control group from 2018 and 2019.Results: A total of 1358 GDM patients were included in the analysis, including 484 in 2018, 468 in 2019, and 406 in 2020. GDM patients with home quarantine in 2020 had higher glycemic levels and worse pregnancy outcomes than 2018 and 2019, including higher cesarean section rate,lower Apgar scores, and higher incidence of macrosomia and nuchal cord. More importantly, the second trimester of home quarantine had brought a broader impactto pregnant women and fetuses.Conclusion: Home quarantine has aggravated the condition of GDM pregnant women and brought more adverse pregnancy outcomes during the COVID-19 outbreak. Therefore, we suggested that governments and hospitals should strengthen lifestyle guidance, glucose management, and antenatal care for GDM patients with home quarantine during public health emergencies.


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