Coronavirus Diseases in Pregnant Women, the Placenta, Fetus, and Neonate

The regulatory framework for considering the fetal effects of new drugs is limited. This is partially due to the fact that pediatric regulations (21 CFR subpart D) do not apply to the fetus, and only US Health and Human Service (HHS) regulations apply to the fetus. The HHS regulation 45 CFR Part 46 Subpart B limits research approvable by an institutional review board to research where the risk to the fetus is minimal unless the research holds out the prospect of a direct benefit to the fetus or the pregnant woman (45 CFR 46.204). Research that does not meet these requirements, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health of pregnant women, fetuses, or neonates, may be permitted by the Secretary of the HHS after expert panel consultation and opportunity for public review and comment (45 CFR 46.407). If the product is regulated by the US Food and Drug Administration (FDA), FDA may get involved in the review process. The FDA does however have a Reviewer Guidance on Evaluating the Risks of Drug Exposure in Human Pregnancies from 2005 and this guidance does discuss the intensity of drug exposure. Estimation of that exposure using physiologically based pharmacokinetic (PBPK) modeling has been suggested by some investigators. Given that drug exposure during pregnancy will impact the fetus, a number of new guidances in the last 2 years also address inclusion of pregnant women in clinical drug trials. Therefore, the drug-specific information on fetal pharmacology will increase dramatically in the next decade due to interest in drugs administered in pregnancy and with the assistance of model-informed drug development.

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Protective vaccinations during pregnancy - adult Poles knowledge in this area

BMC Public Health ◽

10.1186/s12889-021-11336-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Józefa Dąbek ◽

Oskar Sierka ◽

Halina Kulik ◽

Zbigniew Gąsior

Keyword(s):

Pregnant Women ◽

Acquired Immunity ◽

Third Trimester ◽

Biological Origin ◽

Live Vaccines ◽

The Public ◽

The Third ◽

Planned Pregnancy ◽

Fetus And Neonate ◽

In Pregnancy

Abstract Background The vaccine is a preparation of biological origin containing antigens that stimulate the body’s immune system to produce acquired immunity. Vaccines can contain killed or “live” (attenuated) microorganisms as well as fragments of these (antigens). Although many vaccines are used routinely in pregnancy to provide a seroprotective immune response for mother, fetus and neonate there is much controversy over their use during this unique time. The aim of the study was to find out about the knowledge of adult Poles on the use of preventive vaccinations during pregnancy. Methods The study involved 700 people (100%) aged 18 to 80 years ($$ \overline{x} $$ x ¯ = 32.16 ± 16.46). Most of the respondents were women (511; 73%). The study consisted of 9 questions about preventive vaccinations of pregnant women and 5 questions about members of the studied group. The aforementioned questions formed the basis of the preparation of the presented article. Results A significant part of respondents (322; 46%) did not have knowledge on the topic of safeness of using preventive vaccinations during pregnancy, 196 (28%) respondents believed that such procedure is not safe. Most of the respondents (371; 53%) did not know about the possibility of using “live” vaccines during pregnancy. 14 (2%) of respondents believed that pregnancy should be terminated in case of administration of a “live” vaccine to a pregnant woman. According to 294 (42%) respondents, vaccinations with “live” vaccines should be completed at least 3 months before the planned pregnancy. The subjects were not aware of the issue of post-exposure vaccination against tetanus and rabies among pregnant women. The respondents’ responses were divided on the issue of the safest trimester of pregnancy for vaccine administration. Almost 1/3 of the respondents (203; 29%) indicated the third trimester as the safest for their performance. Conclusion The knowledge of the surveyed group, the majority of whom were women, about the use of vaccinations before and during pregnancy was unsatisfactory. There is a need to educate the public about the benefits and risks of performing or avoiding preventive vaccinations during pregnancy.

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Maternal COVID-19 Vaccination and Its Potential Impact on Fetal and Neonatal Development

Vaccines ◽

10.3390/vaccines9111351 ◽

2021 ◽

Vol 9 (11) ◽

pp. 1351

Author(s):

Niel A. Karrow ◽

Umesh K. Shandilya ◽

Steven Pelech ◽

Lauraine Wagter-Lesperance ◽

Deanna McLeod ◽

...

Keyword(s):

Pregnant Women ◽

First Generation ◽

Viral Vector ◽

Vaccine Safety ◽

Long Term Outcomes ◽

Neonatal Development ◽

Potential Impact ◽

Post Hoc ◽

Fetus And Neonate

Vaccines have been developed at “warp speed” to combat the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus. Although they are considered the best approach for preventing mortality, when assessing the safety of these vaccines, pregnant women have not been included in clinical trials. Thus, vaccine safety for this demographic, as well as for the developing fetus and neonate, remains to be determined. A global effort has been underway to encourage pregnant women to get vaccinated despite the uncertain risk posed to them and their offspring. Given this, post-hoc data collection, potentially for years, will be required to determine the outcomes of COVID-19 and vaccination on the next generation. Most COVID-19 vaccine reactions include injection site erythema, pain, swelling, fatigue, headache, fever and lymphadenopathy, which may be sufficient to affect fetal/neonatal development. In this review, we have explored components of the first-generation viral vector and mRNA COVID-19 vaccines that are believed to contribute to adverse reactions and which may negatively impact fetal and neonatal development. We have followed this with a discussion of the potential for using an ovine model to explore the long-term outcomes of COVID-19 vaccination during the prenatal and neonatal periods.

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Prospective Cohort Study of the Safety of an Influenza A(H1N1) Vaccine in Pregnant Chinese Women

Clinical and Vaccine Immunology ◽

10.1128/cvi.00375-14 ◽

2014 ◽

Vol 21 (9) ◽

pp. 1282-1287 ◽

Cited By ~ 12

Author(s):

Fubao Ma ◽

Longhua Zhang ◽

Renjie Jiang ◽

Jinlin Zhang ◽

Huaqing Wang ◽

...

Keyword(s):

Pregnant Women ◽

Influenza A ◽

Chinese Women ◽

Seroconversion Rate ◽

Exact Probability ◽

H1n1 Vaccine ◽

Influenza A H1n1 ◽

Prolonged Pregnancy ◽

A Prospective Study ◽

Fetus And Neonate

ABSTRACTTo monitor and evaluate the safety of the influenza A(H1N1) vaccine in pregnant women and its influence on the fetus and neonate, we performed a prospective study in which 122 pregnant Chinese women who received the influenza A(H1N1) vaccine and 104 pregnant women who did not receive any vaccine (serving as controls) were observed. The results indicated that the seroconversion rate in the vaccinated group was 90.4% (95% confidence interval [CI], 82.6% to 95.5%). The rate of adverse events following immunization in the pregnant women who received the influenza A(H1N1) vaccine was 3.3%. The spontaneous abortion rates in the vaccinated group and the unvaccinated group were 0.8% and 1.9%, respectively (exact probability test,P= 0.470), the prolonged-pregnancy rates were 8.2% and 4.8%, respectively (χ2= 1.041,P= 0.308), the low-birth-weight rates were 1.6% and 0.95%, respectively (exact probability test,P= 1.000), and the spontaneous-labor rates were 70.5% and 75%, respectively (χ2= 0.573,P= 0.449). All newborns who have an Apgar score of ≥7 are considered healthy; Apgar scores of ≥9 were observed in 38.5% and 57.7% of newborns in the vaccinated group and the unvaccinated group, respectively (χ2= 8.274,P= 0.004). From these results, we conclude that the influenza A(H1N1) vaccine is safe for pregnant women and has no observed adverse effects on fetal growth. (This study has been registered at ClinicalTrials.gov under registration no. NCT01842997.)

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Calcium metabolism in pregnancy and lactation

Obstetric Medicine ◽

10.1258/om.2008.080013 ◽

2009 ◽

Vol 2 (1) ◽

pp. 2-5 ◽

Cited By ~ 4

Author(s):

C P White

Keyword(s):

Pregnant Women ◽

Calcium Metabolism ◽

Successful Implementation ◽

Adaptive Responses ◽

Pregnancy And Lactation ◽

Fetus And Neonate ◽

In Pregnancy

Homeostatic adaptation to maternal calcium metabolism is a prerequisite for optimal delivery of sufficient calcium to the fetus and neonate during pregnancy and lactation, respectively. This article outlines the major adaptations known to occur and the physiological regulators likely to be principally involved. Importantly, different adaptive responses are used in pregnancy and lactation. The rarity of calcium disorders in pregnancy underscores the successful implementation of these adaptations in most women. For those few women with either pre-existing or pregnancy-acquired disorders of calcium metabolism, a knowledge of normal physiology is essential to understand the implications for managing these disorders in pregnant women.

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Perinatal tuberculosis: Diagnostic and therapeutic approach

Medicinski pregled ◽

10.2298/mpns1212496p ◽

2012 ◽

Vol 65 (11-12) ◽

pp. 496-501 ◽

Cited By ~ 1

Author(s):

Slobodanka Petrovic ◽

Radmila Ljustina-Pribic ◽

Branislavka Bjelica-Rodic ◽

Gordana Vilotijevic-Dautovic ◽

Svetlana Cegar

Keyword(s):

Immune Responses ◽

Pregnant Women ◽

Immune Status ◽

Age Distribution ◽

Epidemiological Data ◽

Neonatal Infections ◽

The Past ◽

Diagnostic Difficulties ◽

Fetus And Neonate ◽

In Pregnancy

Introduction. The number of people suffering from tuberculosis has increased rapidly in the whole world over the past three decades. The classical age distribution of disease has also changed. According to the epidemiological data the number of pregnant women having tuberculosis has also risen with the resulting increase in the incidence of perinatal tuberculosis. Pregnancy and Tuberculosis. The presentation of tuberculosis in pregnancy varies. The effects of tuberculosis on pregnancy depend upon various factors: site and extent of the disease, nutritional status and immune status of mother, concomitant diseases, stage of pregnancy when the treatment started and others. A delay between the onset and diagnosis occurs regularly. Treatment response, time to clearance of bacilli from sputum, and prognosis are similar to non pregnant women. Prinatal tuberculosis. Perinatal tuberculosis is extremely rare if the mother is effectively treated in pregnancy, but disease is usually fatal if untreated. Diagnosis of perinatal tuberculosis is very often problematic and difficult. The reason of this is the fact that the initial manifestations of disease are nonspecific and may be delayed. In practice, congenital and early neonatal infections have almost the same mode of presentations, treatment and prognosis. Epidemiological data on the active tuberculosis in mother or some other family member are of the utmost importance in diagnoing tuberculosis. Differences in immune responses in the fetus and neonate add to the diagnostic difficulties already recognised in young children. Tuberculin tests are negative in at least 75% of cases. Conclusion. If the condition is recognized and treated according to existing tuberculosis protocols, the outcome is favourable.

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