Vaccination against COVID-19 infection: the need of evidence for diabetic and obese pregnant women

Abstract Aim The recent availability of vaccines against COVID-19 has sparked national and international debate on the feasibility of administering them to pregnant and lactating women, given that these vaccines have not been tested to assess their safety and efficacy in such women. As concerns the risks of COVID-induced disease, published data show that pregnant women who develop COVID-19 have fewer symptoms than patients who are not pregnant, but they are more likely to need hospitalization in intensive care, and neonatal morbidity. Aim of the present perspective paper is to analyze the current literature regarding the use of the vaccine against COVID-19 infection, in terms of safety and protection, in high risk pregnant women as those affected by diabetes and obesity. Methods Analysis of literature about vaccination against COVID-19 infection in pregnancy. Results The main health organizations and international scientific societies, emphasize that—although data regarding the use of COVID vaccines during pregnancy and lactation are still lacking—vaccination should not be contraindicated. It should be considered for pregnant women at high risk of exposure to COVID-19. For such women, the potential benefits and risks should be assessed by the healthcare professionals caring for them. A recent prospective study to test the immunogenicity and reactogenicity of vaccination with COVID-19 mRNA in pregnant and lactating women, has showed that SARS-CoV-2 mRNA vaccination triggers a robust humoral immunity in pregnant and lactating women; there was also evidence of an immune transfer to their newborn. Conclusions We urgently need data on the effect of COVID-19 vaccination, in terms of maternal and fetal outcomes and vaccine related symptoms in high risk women during pregnancy and breastfeeding. It is important to run campaigns to promote vaccination, in particular in pregnant women at high risk to have severe COVID infection as those diabetics and/or obese.

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INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Pravastatin to Prevent Preeclampsia and its Effects on sFlt1/PLGF Levels

American Journal of Perinatology ◽

10.1055/a-1673-5603 ◽

2021 ◽

Author(s):

Muhammad Ilham Aldika Akbar ◽

Angelina Yosediputra ◽

Raditya Eri Pratama ◽

Nur Lailatul Fadhilah ◽

Sulistyowati Sulistyowati ◽

...

Keyword(s):

High Risk ◽

Pregnant Women ◽

Controlled Trial ◽

Intervention Group ◽

Perinatal Outcomes ◽

Neonatal Morbidity ◽

Clinical Risk Factor ◽

Control Group ◽

Significant Deterioration ◽

Plgf Ratio

Objectives To evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio. Study Design This is an open labelled RCT part of INOVASIA trial. Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin and before delivery. The main outcome was the rate of maternal preeclampsia, maternal-perinatal outcomes, and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly (p=0.048) lower in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights (2931 + 537 vs 2625 + 872 g; p=0.006), lower Apgar scores < 7 (2.5 vs 27.5%, p=0.002), composite neonatal morbidity (0 vs 20%, p=0.005) and NICU admission rates (0 vs 15%, p=0.026). All biomarkers show a significant deterioration in the control group compared with non significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the angiogenic imbalance.

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Potential Maternal and Infant Outcomes from Coronavirus 2019-nCoV (SARS-CoV-2) Infecting Pregnant Women: Lessons from SARS, MERS, and Other Human Coronavirus Infections

Viruses ◽

10.3390/v12020194 ◽

2020 ◽

Vol 12 (2) ◽

pp. 194 ◽

Cited By ~ 251

Author(s):

David A. Schwartz ◽

Ashley L. Graham

Keyword(s):

Pregnant Women ◽

Case Fatality ◽

Neonatal Morbidity ◽

Published Data ◽

Clinical Effects ◽

Infant Outcomes ◽

Republic Of China ◽

Limited Experience ◽

Natural Aerosols ◽

Coronavirus Infections

In early December 2019 a cluster of cases of pneumonia of unknown cause was identified in Wuhan, a city of 11 million persons in the People’s Republic of China. Further investigation revealed these cases to result from infection with a newly identified coronavirus, initially termed 2019-nCoV and subsequently SARS-CoV-2. The infection moved rapidly through China, spread to Thailand and Japan, extended into adjacent countries through infected persons travelling by air, eventually reaching multiple countries and continents. Similar to such other coronaviruses as those causing the Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), the new coronavirus was reported to spread via natural aerosols from human-to-human. In the early stages of this epidemic the case fatality rate is estimated to be approximately 2%, with the majority of deaths occurring in special populations. Unfortunately, there is limited experience with coronavirus infections during pregnancy, and it now appears certain that pregnant women have become infected during the present 2019-nCoV epidemic. In order to assess the potential of the Wuhan 2019-nCoV to cause maternal, fetal and neonatal morbidity and other poor obstetrical outcomes, this communication reviews the published data addressing the epidemiological and clinical effects of SARS, MERS, and other coronavirus infections on pregnant women and their infants. Recommendations are also made for the consideration of pregnant women in the design, clinical trials, and implementation of future 2019-nCoV vaccines.

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Evidence of inadequate docosahexaenoic acid status in Brazilian pregnant and lactating women

Revista de Saúde Pública ◽

10.1590/s0034-89102009000200018 ◽

2009 ◽

Vol 43 (2) ◽

pp. 359-368 ◽

Cited By ~ 12

Author(s):

Alexandre G Torres ◽

Nádia M F Trugo

Keyword(s):

Breast Milk ◽

Docosahexaenoic Acid ◽

Dietary Intake ◽

Population Based ◽

Food Sources ◽

Published Data ◽

Lactating Women ◽

Adolescents And Adults ◽

Pregnancy And Lactation ◽

Biochemical Indices

Recently published data concerning dietary intake of fat and food sources of (n-3) long-chain polyunsaturated fatty acids (LCPUFA) in Brazil are reviewed together with data on biochemical indices of PUFA status during pregnancy and lactation and PUFA composition of breast milk in Brazilian adolescents and adults. Potential inadequacies of docosahexaenoic acid (DHA) status among Brazilian pregnant and lactating women have not yet been thoroughly evaluated. The data reviewed show that dietary intake of food sources of n-3 LCPUFA is low and possibly deficient in Brazil, and that biochemical indices of maternal DHA status and breast milk DHA content are low compared to the international literature. These data indicate inadequate DHA status among Brazilian women during pregnancy and lactation, but this evidence needs confirmation through comprehensive and specific population-based studies.

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Iodine nutrition in pregnancy and lactation in Iran

Public Health Nutrition ◽

10.1017/s1368980007360977 ◽

2007 ◽

Vol 10 (12A) ◽

pp. 1596-1599 ◽

Cited By ~ 22

Author(s):

Fereidoun Azizi

Keyword(s):

Pregnant Women ◽

Urinary Iodine ◽

Thyroid Volume ◽

Iodine Concentration ◽

Iodine Intake ◽

Urinary Iodine Excretion ◽

Urinary Iodine Concentration ◽

Lactating Women ◽

Iodine Excretion ◽

Pregnancy And Lactation

AbstractObjective: To describe studies evaluating urinary iodine excretion during pregnancy and lactation in women living in cities with adequate or more than adequate iodine intake.Design: Cross-sectional study conducted between 1996 and 1998 in pregnant women and a study of lactating women conducted in 2003.Settings and Subjects: Pregnant women attending prenatal clinics in four cities in the Islamic Republic of Iran. Urinary iodine excretion and thyroid volume was measured in 403 women. In a second study, 100 lactating women from Taleghani Hospital in Gorgan, Iran were evaluated for thyroid size, and both urinary and breast milk iodine concentrations were determined.Results: In Rasht city, 84% of pregnant women had a urinary iodine concentration of ≥ 200 μg l-1, while in the other cities this percentage ranged from 45 to 55%. When data were combined for the cities of Ilam, Isfahan and Tehran, where women have an adequate or more than adequate median urinary iodine concentration, 51% of pregnant women had a urinary iodine concentration less than that recommended during pregnancy. In Rasht, where the median urinary iodine concentration indicates an excessive iodine intake, 15.4% of pregnant women had a urinary iodine concentration < 200 μg l-1. The mean urinary iodine concentration in lactating women was 250 μg l-1, and 16% of women had a urinary iodine concentration < 100 μg l-1. Grade 1 goitre was present in 8% of lactating women, and another 8% had grade 2 goitre.Conclusions: Findings of this study call for further attention to iodine intake during pregnancy and lactation. The currently recommended intake of iodine through universal salt iodisation may not be adequate for pregnant and lactating women, and supplementation during pregnancy and lactation should be further considered in light of the latest recommendations.

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The Burden of Hyperglycemia First Detected in Pregnancy Among Indonesian Women

10.21203/rs.3.rs-41116/v1 ◽

2020 ◽

Author(s):

Najmiatul Fitria ◽

Ivan Surya Pradipta ◽

Bobby Indra Utama ◽

Maarten Postma ◽

Antoinette van Asselt ◽

...

Keyword(s):

High Risk ◽

Maternal Health ◽

Pregnant Women ◽

Fasting Blood Glucose ◽

World Health ◽

Oral Glucose ◽

High Risk Women ◽

Glucose Levels ◽

Risk Of Death ◽

In Pregnancy

Abstract OBJECTIVE: Despite improvements, Indonesian maternal health falls short of the Sustainable Development Goals. Using contemporary electronic healthcare records, this study explored the burden of Hyperglycemia First Detected in Pregnancy (HFDP) and its association with the determinants of maternal health in Indonesia. METHODS: Electronic Health Records data were extracted on high-risk pregnant women without pre-existing diabetes who were screened for HFDP between 2014 and 2015 at two West Sumatera hospitals. Screening consisted of an oral glucose tolerance test (OGTT), grouping women into Diabetes In Pregnancy (DIP, glucose 126 mg/dl), Gestational Diabetes Mellitus (GDM, glucose 92-125 mg/dl), or high-risk women without elevated glucose levels (glucose < 92 mg/dl); following the World Health Organization (WHO) standard. Maternal and neonatal outcomes, including mortality, were associated with the three diabetes statuses, using general and generalized linear models (depending on the type of outcome) adjusted for maternal age and parity. RESULT: 3536 pregnant women were screened, of which 722 (21%) had HFDP; 655 (19%) were classified as GDM and 67 (2%) as DIP. Women with HFDP did not have a significantly higher risk of death: OR 1.36 (95%-CI 0.71-2.62) for GDM and 0.90 (95%-CI 0.12-6.67) for DIP. We did observe a significantly lower neonatal death rate for children born of GDM women, with three deaths (1%) compared to 178 (6%) in high-risk normal FBG women (p-value < 0.01). This observation was not replicated when comparing DIP to normal FBG women (OR 0.58; 95%-CI 0.26-1.29). CONCLUSION: The observed lack of difference in pregnancy outcomes between HFDP and pregnant women with normal fasting blood glucose levels (at the time of screening) reflects the considerable residual risk of these women. Nevertheless, have and calls for closer monitoring of high-risk women irrespective of their OGTT results. Larger sample-sized studies are warranted to replicate findings with sufficient accuracy to detect possibly smaller, but meaningful differences.

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Streptococcus agalactiae colonization and screening approach in high-risk pregnant women in southern Brazil

The Journal of Infection in Developing Countries ◽

10.3855/jidc.12025 ◽

2020 ◽

Vol 14 (04) ◽

pp. 332-340

Author(s):

Jeane Zanini da Rocha ◽

Jéssica Feltraco ◽

Vanessa Radin ◽

Carla Vitola Gonçalves ◽

Pedro Eduardo Almeida da Silva ◽

...

Keyword(s):

High Risk ◽

Pregnant Women ◽

Low Cost ◽

Group B Streptococcus ◽

Neonatal Morbidity ◽

Neonatal Infection ◽

Diagnostic Methods ◽

Antenatal Screening ◽

Group B ◽

The Impact

Introduction: Considering that Group B Streptococcus (GBS) persists as an important cause of neonatal morbidity and mortality, the objective of this study was to evaluate the frequency of maternal colonization by GBS, comparing the culture by the Granada broth with the GeneXpert real-time PCR diagnostic methods and the impact of chemoprophylaxis in high-risk pregnant women. Methodology: A prospective cohort of 110 pregnant women hospitalized for gestational complications was formed and recruited following interview and collection of rectovaginal swabs. Results: The frequency of maternal colonization was 28.2% and statistically associated with Capurro> 37 weeks (p = 0.030) and neonatal infection (p = 0.008). Chemoprophylaxis was offered to 80% of those colonized. Among the pregnant women treated, a fivefold reduction in the rate of prematurity and rate of neonatal infection was observed. The sensitivity was 76.6% and 86.6% in culture and PCR, respectively, with an optimal index of agreement between the methods (K = 0.877). Grenade culture was considered an easy and low-cost method, while GeneXpert presented higher cost and error rate of 10%. However, 23.3% of the pregnant women were diagnosed exclusively by GeneXpert and the results were obtained in two hours. Conclusions: This study showed a significant prevalence of maternal colonization for GBS and that both culture and molecular methods had peculiarities that allow different applicability, with the culture being feasible for antenatal screening and in the hospital for high-risk pregnant women with no sign of imminent delivery and GeneXpert being prioritized for situations of preterm birth.

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A Qualitative Study to Explore the Barriers for Nonadherence to Referral to Hospital Births by Women with High-Risk Pregnancies in Nepal

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18115801 ◽

2021 ◽

Vol 18 (11) ◽

pp. 5801

Author(s):

Sushma Rajbanshi ◽

Mohd Noor Norhayati ◽

Nik Hussain Nik Hazlina

Keyword(s):

High Risk ◽

Qualitative Study ◽

Neonatal Morbidity ◽

Referral Hospital ◽

Sociocultural Factors ◽

Targeted Interventions ◽

Hospital Birth ◽

High Risk Women ◽

Information Barriers ◽

Hospital Births

Maternal and neonatal morbidity and mortality tend to decrease if referral advice during pregnancy is utilized appropriately. This study explores the reasons for nonadherence to referral advice among high-risk pregnant women. A qualitative study was conducted in Morang District, Nepal. A phenomenological inquiry was used. Fourteen participants were interviewed in-depth. High-risk women who did not comply with the referral to have a hospital birth were the study participants. Participants were chosen purposively until data saturation was achieved. The data were generated using thematic analysis. Preference of homebirth, women’s diminished autonomy and financial dependence, conditional factors, and sociocultural factors were the four major themes that hindered hospital births. Women used antenatal check-ups to reaffirm normalcy in their current pregnancies to practice homebirth. For newly-wed young women, information barriers such as not knowing where to seek healthcare existed. The poorest segments and marginalized women did not adhere to referral hospital birth advice even when present with high-risk factors in pregnancy. Multiple factors, including socioeconomic and sociocultural factors, affect women’s decision to give birth in the referral hospital. Targeted interventions for underprivileged communities and policies to increase facility-based birth rates are recommended.

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Combined prevention of fetal growth restriction based on determination of diagnostic markers

EUREKA Health Sciences ◽

10.21303/2504-5679.2021.001849 ◽

2021 ◽

pp. 9-15

Author(s):

Vladimir Golyanovskyi

Keyword(s):

High Risk ◽

Pregnant Women ◽

Preventive Measures ◽

Comparison Group ◽

Fetal Distress ◽

Main Group ◽

Growth Restriction ◽

Control Group ◽

High Risk Women ◽

Micro Elements

Due to the morbidity of mothers and newborns caused by fetal growth restriction (FGR) and preeclampsia, preventive measures should be taken, especially in women at high risk of developing these conditions. Many studies have been conducted on the prevention of FGR and preeclampsia in high-risk women, especially anticoagulants, aspirin, paravastatin, nitric oxide, microelements (L-arginine, folic acid, vitamins E and C, phytonutrients, vitamin D) and calcium. The aim is to improve perinatal consequences by preventing FGR in high-risk women. Materials and methods: A prospective study of 137 pregnant women in the period of 110–136 weeks was conducted at the Perinatal Center in Kyiv. Pregnant women were divided into 3 groups. The main group included 47 women at high risk of FGR who received therapy (low doses of aspirin, low molecular weight heparin (LMWH) and vitamin and micro elements drugs). The comparison group included 45 women who had a high risk of FGR but did not receive treatment. The control group consisted of 45 women who were not at risk of FGR. The frequency of FGR and placental dysfunction were analyzed as well as a fetal distress was analyzed ante- and intranatally. Results: Therapy with low doses of aspirin, LMWH and a complex preparation of vitamins and micro elements improves the course of pregnancy and gestational complications. In the main group FGR was detected in 8.5 %, in the comparison group – in 17.8 %, in the control group – 4.4 %. Placental dysfunction was detected in 13.3 % in the control group, and only 6.4 % in the main group that was close to the control group – 2.2 %. Similar tendencies were found for fetal distress ante- and intranatally. Conclusions: The proposed prophylactic measures can improve maternal outcomes by reducing the level of gestational complications in pregnant women with biochemical signs of risk of FGR development. In addition, these preventive measures can reduce the frequency of children births with growth restriction, which significantly reduces early neonatal and perinatal morbidity and mortality.

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Detection of Circulating Mammary Mucin (MUC1) and MUC1 Immune Complexes (MUC1-CIC) in Healthy Women

The International Journal of Biological Markers ◽

10.1177/172460080101600205 ◽

2001 ◽

Vol 16 (2) ◽

pp. 112-120 ◽

Cited By ~ 16

Author(s):

M.V. Croce ◽

M.T. Isla-Larrain ◽

M.R. Price ◽

A. Segal-Eiras

Keyword(s):

Breast Cancer ◽

Pregnant Women ◽

Immune Complexes ◽

Epidemiological Evidence ◽

Serum Samples ◽

Lactating Women ◽

Humoral Immune ◽

Healthy Women ◽

Pregnancy And Lactation ◽

Study Population

There is convincing epidemiological evidence that multiparity provides protection against the development of breast cancer. In the present study we evaluated the levels of MUC1 and MUC1 circulating immune complexes (MUC1-CIC) in 135 serum samples obtained from healthy women. The study population included 13 women who had never been pregnant, 31 primiparous pregnant women, 36 multiparous pregnant women who had lactated, 5 multiparous pregnant women who had never lactated, 24 multiparous non-pregnant women who were lactating at the time of the study, 24 multiparous non-pregnant women who had lactated, and 2 multiparous non-pregnant women who had never lactated. The purpose of this work was to detect MUC1 variations during pregnancy and lactation as well as to study the possible induction of a humoral immune response against MUC1 in these conditions. We employed ELISA techniques to measure MUC1 (CASA test) and MUC1-CIC (IgM and IgG) using two anti-MUC1 monoclonal antibodies (MAbs): C595 and SM3. Statistical analysis was performed using the ANOVA test. The pooled results pertaining to pregnant versus non-pregnant women were compared and significant differences were observed in MUC1 and MUC1-CIC-IgM levels detected with both MAbs; the MUC1-CIC-IgG levels detected with C595 were increased in the pregnant group while the MUC1-CIC-IgG levels detected with SM3 did not show any significant differences. When the results were compared between lactating and non-lactating women, no significant differences were found. In conclusion, MUC1 and MUC1-CIC-IgM, detected with both MAbs, and MUC1-CIC-IgG levels detected with the MAb C595 are apparently induced by pregnancy.

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Early Pregnancy Screening for Women at High-Risk of GDM Results in Reduced Neonatal Morbidity and Similar Maternal Outcomes to Routine Screening

Journal of Pregnancy ◽

10.1155/2020/9083264 ◽

2020 ◽

Vol 2020 ◽

pp. 1-6

Author(s):

Erin Clarke ◽

Thomas J. Cade ◽

Shaun Brennecke

Keyword(s):

High Risk ◽

Early Pregnancy ◽

International Association ◽

Neonatal Morbidity ◽

Study Groups ◽

High Risk Group ◽

Adverse Outcomes ◽

Study Objective ◽

High Risk Women ◽

Retrospective Audit

The Australasian Diabetes in Pregnancy Society recommends screening high-risk women for gestational diabetes mellitus (GDM) before 24 weeks gestation, under the assumption that an earlier diagnosis and opportunity to achieve normoglycemia will minimize adverse outcomes. However, little evidence exists for this recommendation. The study objective was to compare the pregnancy outcomes of high-risk women diagnosed with GDM before 24 weeks gestation and routinely diagnosed women after 24 weeks gestation. A retrospective audit was conducted of all pregnancies diagnosed with GDM using International Association of Diabetes and Pregnancy Study Groups criteria over 12 months at a tertiary Australian hospital. Adverse perinatal outcomes were compared between “Early GDM” diagnosed before 24 weeks (n=133) and “Late GDM” diagnosed from 24 weeks (n=636). Early GDM had a significantly lower newborn composite outcome frequency (hypoglycemia, birth trauma, NICU/SCN admission, stillbirth, neonatal death, respiratory distress, and phototherapy) compared to Late GDM (20.3% vs. 30.0%, p=0.02). Primary cesarean, hypertensive disorders, postpartum hemorrhage, birthweight >90th percentile, macrosomia, and preterm birth frequencies were not significantly different between groups. Therefore, high-risk women diagnosed with GDM in early pregnancy were not more likely to have an adverse outcome compared to routinely diagnosed women. As they are a high-risk group, this may indicate a possible benefit to the early diagnosis of GDM.

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