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1.
Sensors (Basel) ; 22(7)2022 Apr 05.
Article in English | MEDLINE | ID: covidwho-1785899

ABSTRACT

Fetal electrocardiogram (fECG) assessment is essential throughout pregnancy to monitor the wellbeing and development of the fetus, and to possibly diagnose potential congenital heart defects. Due to the high noise incorporated in the abdominal ECG (aECG) signals, the extraction of fECG has been challenging. And it is even a lot more difficult for fECG extraction if only one channel of aECG is provided, i.e., in a compact patch device. In this paper, we propose a novel algorithm based on the Ensemble Kalman filter (EnKF) for non-invasive fECG extraction from a single-channel aECG signal. To assess the performance of the proposed algorithm, we used our own clinical data, obtained from a pilot study with 10 subjects each of 20 min recording, and data from the PhysioNet 2013 Challenge bank with labeled QRS complex annotations. The proposed methodology shows the average positive predictive value (PPV) of 97.59%, sensitivity (SE) of 96.91%, and F1-score of 97.25% from the PhysioNet 2013 Challenge bank. Our results also indicate that the proposed algorithm is reliable and effective, and it outperforms the recently proposed extended Kalman filter (EKF) based algorithm.


Subject(s)
Mothers , Signal Processing, Computer-Assisted , Algorithms , Arrhythmias, Cardiac , Electrocardiography/methods , Female , Fetal Monitoring/methods , Fetus , Humans , Pilot Projects , Pregnancy
3.
Viruses ; 13(12)2021 12 19.
Article in English | MEDLINE | ID: covidwho-1580422

ABSTRACT

BACKGROUND: SARS-CoV-2 infection in pregnant women can lead to placental damage and transplacental infection transfer, and intrauterine fetal demise is an unpredictable event. CASE STUDY: A 32-year-old patient in her 38th week of pregnancy reported loss of fetal movements. She overcame mild COVID-19 with positive PCR test 22 days before. A histology of the placenta showed deposition of intervillous fibrinoid, lympho-histiocytic infiltration, scant neutrophils, clumping of villi, and extant infarctions. Immunohistochemistry identified focal SARS-CoV-2 nucleocapsid and spike protein in the syncytiotrophoblast and isolated in situ hybridization of the virus' RNA. Low ACE2 and TMPRSS2 contrasted with strong basigin/CD147 and PDL-1 positivity in the trophoblast. An autopsy of the fetus showed no morphological abnormalities except for lung interstitial infiltrate, with prevalent CD8-positive T-lymphocytes and B-lymphocytes. Immunohistochemistry and in situ hybridization proved the presence of countless dispersed SARS-CoV-2-infected epithelial and endothelial cells in the lung tissue. The potential virus-receptor protein ACE2, TMPRSS2, and CD147 expression was too low to be detected. CONCLUSION: Over three weeks' persistence of trophoblast viral infection lead to extensive intervillous fibrinoid depositions and placental infarctions. High CD147 expression might serve as the dominant receptor for the virus, and PDL-1 could limit maternal immunity in placental tissue virus clearance. The presented case indicates that the SARS-CoV-2 infection-induced changes in the placenta lead to ischemia and consecutive demise of the fetus. The infection of the fetus was without significant impact on its death. This rare complication of pregnancy can appear independently to the severity of COVID-19's clinical course in the pregnant mother.


Subject(s)
COVID-19/complications , Placenta/pathology , Pregnancy Complications, Infectious , Stillbirth , Adult , Angiotensin-Converting Enzyme 2 , B-Lymphocytes , CD8-Positive T-Lymphocytes , COVID-19/diagnosis , Endothelial Cells/pathology , Female , Fetus/pathology , Humans , Infectious Disease Transmission, Vertical , Placenta/virology , Placenta Diseases/pathology , Placenta Diseases/virology , Pregnancy , Pregnancy Complications, Infectious/pathology , Pregnancy Complications, Infectious/virology , SARS-CoV-2 , Serine Endopeptidases , Spike Glycoprotein, Coronavirus , Trophoblasts
4.
J Perinat Med ; 50(2): 139-143, 2022 Feb 23.
Article in English | MEDLINE | ID: covidwho-1561422

ABSTRACT

OBJECTIVES: To investigate the long-term effects of the SARS-CoV-2 infection on the fetal immune system by fetal thymus size measurements with ultrasound (USG). METHODS: This prospective study was conducted in the Turkish Ministry of Health Ankara City Hospital between November 1, 2020 and April 1, 2021, with recovered, pregnant women, four weeks after they had been confirmed for the SARS-CoV-2 infection by real-time polymerase-chain-reaction (RT-PCR). COVID-19 recovered (CR) pregnant women compared with age-matched pregnant controls in terms of demographic features, fetal thymic-thoracic ratio (TTR), and laboratory parameters. RESULTS: There was no difference in demographic features between the two groups. TTR found significantly lower in the CR group than the control group (p=0.001). The fetal TTR showed a significant and moderate correlation with maternal monocyte counts, monocyte to lymphocyte ratio (MLR), and red cell distribution width (RDW); while it did not correlate with lymphocyte counts, c-reactive protein (CRP), and procalcitonin levels. CONCLUSIONS: The 2019 novel coronavirus disease (COVID-19) reduces fetal thymus size in pregnant women with mild or moderate symptoms after recovery from the infection.


Subject(s)
COVID-19/pathology , Fetus/pathology , Pregnancy Complications, Infectious/pathology , Thymus Gland/pathology , Adult , COVID-19/diagnostic imaging , Female , Fetus/diagnostic imaging , Humans , Organ Size , Pregnancy , Pregnancy Complications, Infectious/diagnostic imaging , Prospective Studies , Thymus Gland/diagnostic imaging , Ultrasonography, Prenatal , Young Adult
5.
J Infect Dis ; 224(Suppl 6): S647-S659, 2021 12 08.
Article in English | MEDLINE | ID: covidwho-1559634

ABSTRACT

BACKGROUND: Expression of angiotensin-converting enzyme 2 (ACE2) and type II transmembrane serine protease (TMPRSS2), host molecules required for viral entry, may underlie sex differences in vulnerability to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We investigated whether placental ACE2 and TMPRSS2 expression vary by fetal sex in the presence of maternal SARS-CoV-2 infection. METHODS: Placental ACE2 and TMPRSS2 expression was quantified by quantitative reverse transcription polymerase chain reaction (RT-PCR) and by Western blot in 68 pregnant women (38 SARS-CoV-2 positive, 30 SARS-CoV-2 negative) delivering at Mass General Brigham from April to June 2020. The impact of fetal sex and maternal SARS-CoV-2 exposure on ACE2 and TMPRSS2 was analyzed by 2-way analysis of variance (ANOVA). RESULTS: Maternal SARS-CoV-2 infection impacted placental TMPRSS2 expression in a sexually dimorphic fashion (2-way ANOVA interaction, P = .002). We observed no impact of fetal sex or maternal SARS-CoV-2 status on ACE2. TMPRSS2 expression was significantly correlated with ACE2 expression in males (Spearman ρ = 0.54, P = .02) but not females (ρ = 0.23, P = .34) exposed to maternal SARS-CoV-2. CONCLUSIONS: Sex differences in placental TMPRSS2 but not ACE2 were observed in the setting of maternal SARS-CoV-2 infection, which may have implications for offspring vulnerability to placental infection.


Subject(s)
Angiotensin-Converting Enzyme 2/metabolism , COVID-19/diagnosis , Fetal Blood/immunology , Placenta/metabolism , SARS-CoV-2/immunology , Serine Endopeptidases/metabolism , Sex Factors , Adult , COVID-19/blood , Female , Fetal Blood/virology , Fetus/virology , Gene Expression , Humans , Infectious Disease Transmission, Vertical , Male , Pregnancy , Pregnancy Complications, Infectious/virology
6.
J Med Virol ; 93(12): 6788-6793, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1562395

ABSTRACT

This study aimed to report a case of mild novel coronavirus disease (COVID-19) in a pregnant woman with probable viremia, as reverse transcription-polymerase chain reaction (RT-PCR) testing of endometrial and placental swabs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was positive. A 26-year-old multigravida at 35 weeks 2 days of gestation, who had extensive thigh and abdominal cellulitis, tested SARS-CoV-2 positive by RT-PCR performed on samples from the endometrium and maternal side of the placenta. However, other samples (amniotic fluid, fetal side of the placenta, umbilical cord, maternal vagina, and neonatal nasopharynx) tested negative for SARS-CoV-2. This is one of the rare reports of probable SARS-CoV-2 viremia with the presence of SARS-CoV-2 in the endometrium and placenta, but not leading to vertical transmission and neonatal infection. Because knowledge about transplacental transmission and results is very limited, we conclude that more RT-PCR tests on placental and cord blood samples are needed in order to safely make definite conclusions.


Subject(s)
COVID-19/virology , Fetus/virology , Placenta/virology , Pregnancy Complications, Infectious/virology , SARS-CoV-2/genetics , Viremia/virology , Adult , Female , Humans , Infectious Disease Transmission, Vertical , Pregnancy , Pregnant Women
7.
Nat Rev Immunol ; 20(9): 518-519, 2020 09.
Article in English | MEDLINE | ID: covidwho-1550305
8.
Bull Exp Biol Med ; 172(1): 85-89, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1520386

ABSTRACT

We performed a comparative morphological analysis of placental villi in parturient women with mild and moderate COVID-19 infection. The area and perimeter of terminal villi, their capillaries, and syncytiotrophoblast were assessed on immunohistochemical preparations with antibodies to CD31 using an image analysis system; the parameters of fetal vascular component in the placental villi were also assessed. Changes in the studied parameters differed in parturient women with mild and moderate COVID-19 infection. The observed increase in the total perimeter with a simultaneous decrease in the total capillary area and the degree of vascularization of the placental villi in parturient women with COVID-19 indicates impairment of circulation in the fetal compartment and the development of placental hypoxia, which can be the cause of unfavorable neonatal outcomes.


Subject(s)
COVID-19/pathology , Chorionic Villi/pathology , Pregnancy Complications, Infectious/pathology , SARS-CoV-2/pathogenicity , Trophoblasts/pathology , Adult , COVID-19/virology , Chorionic Villi/blood supply , Chorionic Villi/virology , Female , Fetus , Humans , Immunohistochemistry , Parturition/physiology , Pregnancy , Pregnancy Complications, Infectious/virology , SARS-CoV-2/growth & development , Severity of Illness Index , Trophoblasts/virology
10.
J Mol Cell Biol ; 13(3): 168-174, 2021 07 06.
Article in English | MEDLINE | ID: covidwho-1493860

ABSTRACT

The high infectivity and pathogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have caused the COVID-19 outbreak, one of the most devastating pandemics in more than a century. This pandemic has already left a trail of destruction, including enormous loss of life, a global economic slump, and widespread psychological damage. Despite assiduous world-wide endeavors, an effective cure for COVID-19 is still lacking. Surprisingly, infected neonates and children have relatively mild clinical manifestations and a much lower fatality rate than elderly adults. Recent studies have unambiguously demonstrated the vertical transmission of SARS-CoV-2 from infected pregnant women to fetuses, which creates yet another challenge for disease prevention. In this review, we will summarize the molecular mechanism for entry of SARS-CoV-2 into host cells, the basis for the failure of the lungs and other organs in severe acute cases, and the evidence for congenital transmission.


Subject(s)
COVID-19/transmission , Infectious Disease Transmission, Vertical , SARS-CoV-2/genetics , Virus Internalization , COVID-19/genetics , COVID-19/pathology , COVID-19/virology , Female , Fetus/virology , Humans , Lung/pathology , Lung/virology , Pandemics , Pregnancy , SARS-CoV-2/pathogenicity
11.
Methods Mol Biol ; 2311: 185-193, 2021.
Article in English | MEDLINE | ID: covidwho-1482181

ABSTRACT

Studies of blood-brain barrier (BBB) require developing of a novel and convenient in vitro endothelial cell model. We isolated primary human and rodent brain microvascular endothelial cells and developed methods for culturing, characterization, and high-efficiency transfection of endothelial cells. Here, we describe the improved methods to obtain in vitro human and rodent BBB models to study expression of endogenous and exogenous genes of interest.


Subject(s)
Blood-Brain Barrier/physiology , Brain/blood supply , Cell Separation , Endothelial Cells/physiology , Microvessels/cytology , Transfection , Animals , Blood-Brain Barrier/metabolism , Cell Culture Techniques , Cell Differentiation , Cell Proliferation , Cells, Cultured , Endothelial Cells/metabolism , Fetus , Gestational Age , Humans , Mice , Rats
12.
BMJ Case Rep ; 14(9)2021 Sep 08.
Article in English | MEDLINE | ID: covidwho-1467678

ABSTRACT

We describe the successful treatment of a 24-week pregnant, 44-year-old woman with COVID-19. Management of this complex case required multidisciplinary collaboration and included prolonged invasive mechanical ventilation and prone positioning. Caesarean section delivery was delayed for 32 days, with no monitored fetal compromise, while stabilising the mother. To our knowledge, this is the longest reported duration of invasive ventilation while pregnant in a patient with COVID-19. COVID-19 has been shown to cause increased disease severity in pregnant women, and certain pregnancy-related physiological adaptations that occur could help explain this association. While COVID-19 has been shown to cause no increased adverse neonatal outcomes, clinicians should be aware that data show increased preterm birth in symptomatic pregnant women, thereby increasing the chance of prematurity-related complications. Further research on COVID-19 in pregnancy is crucial to facilitate better management, and full inclusion of pregnant women in therapeutic clinical trials will help achieve this.


Subject(s)
COVID-19 , Premature Birth , Adult , Cesarean Section , Female , Fetus , Humans , Infant, Newborn , Pregnancy , Pregnant Women , Respiration, Artificial , SARS-CoV-2
13.
BMJ Case Rep ; 14(9)2021 Sep 08.
Article in English | MEDLINE | ID: covidwho-1403048

ABSTRACT

We describe the successful treatment of a 24-week pregnant, 44-year-old woman with COVID-19. Management of this complex case required multidisciplinary collaboration and included prolonged invasive mechanical ventilation and prone positioning. Caesarean section delivery was delayed for 32 days, with no monitored fetal compromise, while stabilising the mother. To our knowledge, this is the longest reported duration of invasive ventilation while pregnant in a patient with COVID-19. COVID-19 has been shown to cause increased disease severity in pregnant women, and certain pregnancy-related physiological adaptations that occur could help explain this association. While COVID-19 has been shown to cause no increased adverse neonatal outcomes, clinicians should be aware that data show increased preterm birth in symptomatic pregnant women, thereby increasing the chance of prematurity-related complications. Further research on COVID-19 in pregnancy is crucial to facilitate better management, and full inclusion of pregnant women in therapeutic clinical trials will help achieve this.


Subject(s)
COVID-19 , Premature Birth , Adult , Cesarean Section , Female , Fetus , Humans , Infant, Newborn , Pregnancy , Pregnant Women , Respiration, Artificial , SARS-CoV-2
14.
Paediatr Int Child Health ; 41(3): 211-216, 2021 08.
Article in English | MEDLINE | ID: covidwho-1398025

ABSTRACT

Neonatal infection with SARS-CoV-2 is considered to have no major complications. A neonate with lower limb gangrene owing to spontaneous aortic thrombosis in the setting of a fetal inflammatory response syndrome (FIRS) post-intrauterine COVID-19 infection is presented. A healthy full-term newborn discharged from hospital on Day 3 developed irritability and progressive blackish discoloration of the toes of the right lower limb on Day 6 of life. Doppler imaging revealed acute thrombosis of the abdominal aorta with a critically ischaemic right lower limb. On Day 11 of life, SARS-CoV-2 RT-PCR was negative but total antibodies (IgG and IgM) were positive in both mother and neonate. The neonate showed raised inflammatory markers including CRP, ESR, interleukin-6, procalcitonin, ferritin and LDH along with elevated N-terminal pro-brain natriuretic peptide and D-dimer. In the absence of clinical signs of sepsis, FIRS was diagnosed. The neonate was treated with corticosteroids, heparin infusion and recombinant tissue plasminogen activator, and required surgical embolectomy followed by right limb amputation. By Day 31 of life, inflammatory markers showed serial return to normal and the neonate was discharged on oral steroids and aspirin. Intrauterine SARS-CoV-2 infection may trigger a systemic inflammatory response in some fetuses which is similar to post-COVID-19 multisystem inflammatory syndrome in children (MIS-C). Development of lower limb gangrene is a unique COVID-19-related neonatal complication and is attributed to thrombo-inflammation.ABBREVIATIONSCRP: C-reactive protein; FIRS: fetal inflammatory response syndrome; MIS-C: multisystem inflammatory syndrome in children; NT-proBNP: N-terminal pro-brain natriuretic peptide; RT-PCR: real-time polymerase chain reaction.


Subject(s)
COVID-19 , Thrombosis , Amputation , COVID-19/complications , Child , Fetal Diseases , Fetus , Humans , Infant, Newborn , Leg , SARS-CoV-2 , Systemic Inflammatory Response Syndrome , Tissue Plasminogen Activator
15.
Int J Mol Sci ; 22(6)2021 Mar 13.
Article in English | MEDLINE | ID: covidwho-1389393

ABSTRACT

As most recently demonstrated by the SARS-CoV-2 pandemic, congenital and perinatal infections are of significant concern to the pregnant population as compared to the general population. These outcomes can range from no apparent impact all the way to spontaneous abortion or fetal infection with long term developmental consequences. While some pathogens have developed mechanisms to cross the placenta and directly infect the fetus, other pathogens lead to an upregulation in maternal or placental inflammation that can indirectly cause harm. The placenta is a temporary, yet critical organ that serves multiple important functions during gestation including facilitation of fetal nutrition, oxygenation, and prevention of fetal infection in utero. Here, we review trophoblast cell immunology and the molecular mechanisms utilized to protect the fetus from infection. Lastly, we discuss consequences in the placenta when these protections fail and the histopathologic result following infection.


Subject(s)
Immunity , Placenta/immunology , Placenta/virology , Pregnancy Complications, Infectious/immunology , Pregnancy Complications, Infectious/virology , Virus Diseases/immunology , Viruses/immunology , Female , Fetus/immunology , Fetus/virology , Humans , Placenta/pathology , Pregnancy , Trophoblasts/immunology , Trophoblasts/virology
16.
Biochim Biophys Acta Mol Basis Dis ; 1867(12): 166248, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1372892

ABSTRACT

The COVID-19 pandemic has infected nearly 178 million people and claimed the lives of over 3.8 million in less than 15 months. This has prompted a flurry of research studies into the mechanisms and effects of SARS-CoV-2 viral infection in humans. However, studies examining the effects of COVID-19 in pregnant women, their placentae and their babies remain limited. Furthermore, reports of safety and efficacy of vaccines for SARS-CoV-2 in pregnancy are limited. This review concisely summarises the case studies and research on COVID-19 in pregnancy, to date. It also reviews the mechanism of infection with SARS-CoV-2, and its reliance and effects upon the renin-angiotensin-aldosterone system. Overall, the data suggest that infection during pregnancy can be dangerous at any time, but this risk to both the mother and fetus, as well as placental damage, increases during the third trimester. The possibility of vertical transmission, which is explored in this review, remains contentious. However, maternal infection with SARS-CoV-2 can increase risk of miscarriage, preterm birth and stillbirth, which is likely due to damage to the placenta.


Subject(s)
COVID-19/metabolism , Fetus/immunology , Infectious Disease Transmission, Vertical/prevention & control , Pregnancy Complications, Infectious/virology , COVID-19/virology , COVID-19 Vaccines/administration & dosage , Female , Fetus/virology , Humans , Infant, Newborn , Pandemics , Placenta/metabolism , Placenta/virology , Pregnancy , Pregnancy Complications, Infectious/immunology , Pregnancy Complications, Infectious/prevention & control , SARS-CoV-2/isolation & purification
17.
Biochim Biophys Acta Mol Basis Dis ; 1867(12): 166244, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1356140

ABSTRACT

The placenta provides a significant physical and physiological barrier to prevent fetal infection during pregnancy. Nevertheless, it is at times breached by pathogens and leads to vertical transmission of infection from mother to fetus. This review will focus specifically on the Zika flavivirus, the HIV retrovirus and the emerging SARS-CoV2 coronavirus, which have affected pregnant women and their offspring in recent epidemics. In particular, we will address how viral infections affect the immune response at the maternal-fetal interface and how the placental barrier is physically breached and discuss the consequences of infection on various aspects of placental function to support fetal growth and development. Improved understanding of how the placenta responds to viral infections will lay the foundation for developing therapeutics to these and emergent viruses, to minimise the harms of infection to the offspring.


Subject(s)
Placenta/virology , Pregnancy Complications, Infectious/virology , Virus Diseases/physiopathology , COVID-19/metabolism , Female , Fetus/virology , HIV Infections/metabolism , HIV-1/pathogenicity , Humans , Infectious Disease Transmission, Vertical/statistics & numerical data , Placenta/metabolism , Pregnancy , Pregnancy Complications, Infectious/epidemiology , SARS-CoV-2/pathogenicity , Zika Virus/pathogenicity , Zika Virus Infection/metabolism
18.
Minerva Obstet Gynecol ; 73(4): 471-481, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1348831

ABSTRACT

Fetal growth restriction is one of the most common obstetric complications, affecting 7-10% of all pregnancies. Affected fetuses are exposed to an adverse environment in utero during a critical time of development and may face long-term health consequences such as increased cardiovascular risk in adulthood. Growth restricted fetuses develop remodeled hearts with signs of systolic and diastolic dysfunction. Cardiac adaptations are more evident in early severe cases, but also present in late onset fetal growth restriction. Cardiovascular remodeling persists into postnatal life, from the neonatal period to adolescence, encompassing an increased susceptibility to adult disease. In this review, we summarize the current evidence on cardiovascular programming associated to fetal growth restriction, its postnatal consequences and potential strategies to reduce their cardiovascular risk.


Subject(s)
Cardiovascular System , Fetal Growth Retardation , Adolescent , Adult , Female , Fetus , Heart , Humans , Infant, Newborn , Pregnancy , Ventricular Remodeling
19.
Reprod Toxicol ; 104: 134-142, 2021 09.
Article in English | MEDLINE | ID: covidwho-1331182

ABSTRACT

AZD1222 (ChAdOx1 nCoV-19) is a COVID-19 vaccine that is not yet licensed for use during pregnancy. To support the inclusion of pregnant and breastfeeding people in AZD1222 clinical studies, a non-clinical developmental and reproductive toxicity study was performed to evaluate its effects on fertility and reproductive processes of female CD-1 mice during the embryofetal development phase, and postnatal outcomes during the littering phase. Immunogenicity assessments were also made in dams, fetuses, and pups. There were no vaccine-related unscheduled deaths throughout the study. Furthermore, there were no vaccine-related effects on female reproduction, fetal or pup survival, fetal external, visceral, or skeletal findings, pup physical development, and no abnormal gross pathology findings in pups or dams. Antibody responses raised in dams were maintained throughout gestation and postnatal periods, and seroconversion in fetuses and pups indicate placental and lactational transfer of immunoglobulins. Together with clinical data from non-pregnant people, these results support the inclusion of pregnant and breastfeeding people in AZD1222 clinical studies.


Subject(s)
Antibodies, Viral/blood , COVID-19 Vaccines/administration & dosage , Immunogenicity, Vaccine , Vaccination , Animals , Biomarkers/blood , COVID-19 Vaccines/toxicity , Female , Fetus/drug effects , Fetus/immunology , Fetus/metabolism , Gestational Age , Lactation/immunology , Lactation/metabolism , Maternal-Fetal Exchange , Mice , Placenta/immunology , Placenta/metabolism , Pregnancy , Prenatal Exposure Delayed Effects , Risk Assessment , Seroconversion
20.
Am J Obstet Gynecol ; 225(1): 33-42, 2021 07.
Article in English | MEDLINE | ID: covidwho-1312880

ABSTRACT

Pregnant and lactating women are considered "therapeutic orphans" because they generally have been excluded from clinical drug research and the drug development process owing to legal, ethical, and safety concerns. Most medications prescribed for pregnant and lactating women are used "off-label" because most of the clinical approved medications do not have appropriate drug labeling information for pregnant and lactating women. Medications that lack human safety data on use during pregnancy and lactation may pose potential risks for adverse effects in pregnant and lactating women as well as risks of teratogenic effects to their unborn and newborn babies. Federal policy requiring the inclusion of women in clinical research and trials led to considerable changes in research design and practice. Despite more women being included in clinical research and trials, the inclusion of pregnant and lactating women in drug research and clinical trials remains limited. A recent revision to the "Common Rule" that removed pregnant women from the classification as a "vulnerable" population may change the culture of drug research and drug development in pregnant and lactating women. This review article provides an overview of medications studied by the Obstetric-Fetal Pharmacology Research Units Network and Centers and describes the challenges in current obstetrical pharmacology research and alternative strategies for future research in precision therapeutics in pregnant and lactating women. Implementation of the recommendations of the Task Force on Research Specific to Pregnant Women and Lactating Women can provide legislative requirements and opportunities for research focused on pregnant and lactating women.


Subject(s)
Drug Development , Lactation , Pregnancy , Pregnant Women , COVID-19/drug therapy , COVID-19/prevention & control , COVID-19 Vaccines , Diabetes, Gestational/drug therapy , Drug Approval/legislation & jurisprudence , Drug Development/legislation & jurisprudence , Female , Fetus/drug effects , Humans , Obstetric Labor, Premature/drug therapy , Pre-Eclampsia/drug therapy , Pregnancy/physiology , Pregnancy Complications/drug therapy , Pregnancy Complications/prevention & control , Pregnancy Complications/virology , SARS-CoV-2/immunology , Teratogenesis
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