To date, mother‐to‐fetus transmission of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), responsible for the coronavirus disease 2019 (COVID‐19) pandemic, remains controversial. ...Although placental COVID‐19 infection has been documented in some cases during the second‐ and third‐trimesters, no reports are available for the first trimester of pregnancy, and no SARS‐CoV‐2 protein has been found in fetal tissues. We studied the placenta and fetal organs from an early pregnancy miscarriage in a COVID‐19 maternal infection by immunohistochemical, reverse transcription quantitative real‐time polymerase chain reaction, immunofluorescence, and electron microscopy methods. SARS‐CoV‐2 nucleocapsid protein, viral RNA, and particles consistent with coronavirus were found in the placenta and fetal tissues, accompanied by RNA replication revealed by double‐stranded RNA (dsRNA) positive immunostain. Prominent damage of the placenta and fetal organs were associated with a hyperinflammatory process identified by histological examination and immunohistochemistry. The findings provided in this study document that congenital SARS‐CoV‐2 infection is possible during the first trimester of pregnancy and that fetal organs, such as lung and kidney, are targets for coronavirus. The infection and multi‐organic fetal inflammation produced by SARS‐CoV‐2 during early pregnancy should alert clinicians in the assessment and management of pregnant women for possible fetal consequences and adverse perinatal outcomes.
Passive transplacental immunity is crucial for neonatal protection from infections. Data on the correlation between neonatal immunity to SARS-CoV-2 and protection from adverse outcomes is scarce. ...This work aimed to describe neonatal seropositivity in the context of maternal SARS-CoV-2 infection, seropositivity, and neonatal outcomes. This retrospective nested case-control study enrolled high-risk pregnant women with a SARS-CoV-2 RT-PCR positive test who gave birth at the Instituto Nacional de Perinatología in Mexico City and their term neonates. Anti-SARS-CoV-2 IgG antibodies in maternal and cord blood samples were detected using a chemiluminescent assay. In total, 63 mother-neonate dyads (mean gestational age 38.4 weeks) were included. Transplacental transfer of SARS-CoV-2 IgG occurred in 76% of neonates from seropositive mothers. A positive association between maternal IgG levels and Cycle threshold (Ct) values of RT-qPCR test for SARS-CoV-2 with neonatal IgG levels was observed. Regarding neonatal outcomes, most seropositive neonates did not require any mechanical ventilation, and none developed any respiratory morbidity (either in the COVID-19 positive or negative groups) compared to 7 seronegative neonates. Furthermore, the odds of neonatal respiratory morbidity exhibited a tendency to decrease when neonatal IgG levels increase. These results add further evidence suggesting passive IgG transfer importance.
Objective: To analyze the short-term efficacy and safety over menopausal symptoms of three low-dose continuous sequential 17β-estradiol (E)/progesterone (P) parental monthly formulations using novel ...non-polymeric microspheres.
Methods: This was a multicenter, randomized, single blinded study in which peri- and postmenopausal women were assigned to receive a monthly intramuscular injection of 0.5 mg E + 15 mg P (Group A, n = 34), 1 mg E + 20 mg P (Group B, n = 24) or 1 mg E + 30 mg P (Group C, n = 26) for 6 months. Primary efficacy endpoints included mean change in the frequency and severity of hot flushes and the effect over urogenital atrophy symptoms at 3 and 6 months. Safety variables included changes in the rate of amenorrhea, endometrial thickness and histopathology, and local and systemic adverse events.
Results: Compared to baseline at month 6, the three treatment schemes significantly decreased the rate of urogenital atrophy symptoms and the frequency (mean number per day) and severity (mean number graded as moderate and severe per month) of hot flushes. No differences in studied efficacy parameters were observed between studied groups at baseline or at the end of the study. For all groups the most frequent adverse event was pain at the injection site; however they were all rated as mild. At the end of the study peri- and postmenopausal women displayed no significant changes in endometrial thickness or histopathology in all treated groups. The rate of amenorrhea at the end of the study decreased for all studied groups yet was less evident among postmenopausal women as compared to perimenopausal ones.
Conclusions: The three low-dose continuous sequential intramuscular monthly treatments of E/P using novel microsphere technology were effective at reducing menopausal symptoms at short-term with a low rate of adverse events. More long-term and comparative research is warranted to support our positive findings.
As intramuscular progesterone administration is associated with local intolerance, the purpose of this work was to determine the local tolerability of a new progesterone microsphere suspension, ...administered by intramuscular injection.
An observational, longitudinal, prospective, analytical, multicenter, active pharmacovigilance study was conducted. Two hundred and seven progesterone microsphere administrations were evaluated. Patients evaluated pain, burning sensation, pruritus and dysesthesia. Physicians evaluated erythema, pallor, petechia, ecchymosis, bleeding, edema, induration, abscess, macule, papule, vesicle and pustule. Local tolerability was evaluated using a visual analog scale (100-mm line) on the day of administration, and subsequently on days 3 and 7. Local symptoms were evaluated by patients and local signs by the attending physicians.
On the day of application, 68.4% of the administered doses were associated with 'absent' or 'mild' pain, rising to 91.2% on the 7th day; 83.0% of doses were associated with 'absence' of or a 'mild' burning sensation on the day of administration, rising to 99.5% on day 7. On administration day, 13.2% reported 'mild' erythema and 1.0% 'moderate' erythema, and 3.9% of doses had 'mild' induration and 0.5% 'moderate' induration, which increased to 16.6 and 2.9% on day 3, respectively. The values for pallor, ecchymosis, bleeding, edema and pustule were lower than 10 mm (of 100 mm) on the application day and behaved similarly in subsequent days. There were no reports of petechia, abscess, macule, papule or vesicle with the dose application.
Progesterone microspheres were well tolerated without serious or unexpected adverse effects.
Veralipride is a nonhormonal option for the treatment of vasomotor symptoms of menopause. Incidence of adverse events in a Mexican population and drug compliance according to correct use were ...evaluated.
We carried out a longitudinal, prospective, and analytical study in Mexican women who received veralipride to treat symptoms of menopause from 2011 to 2012. There were 386 treatment cycles; 272 were assigned to dosing schedule 1, which included 20 days of treatment with 10 days of suspension, and 114 were assigned to dosing schedule 2, which included 5 days of treatment and 2 days of suspension.
A total of 57 adverse events were registered during the 386-month treatment. For the 20 × 10 dosing schedule, the highest incidence was observed for anxiety (2.2%), drowsiness, and weakness (1.5%); for the 5 × 2 dosing schedule, the highest incidence was observed for drowsiness (5.3%) and headache (2.6%). The Hamilton Depression Rating Scale was used to assess the presence and severity of depression; improvement was noted. The Unified Parkinson's Disease Rating Scale was used to assess neurological movement disorders; no adverse neurological events were detected. Based on the assessments of both women and physicians, the highest frequency was observed for "very satisfied" (45.5% and 52.3%, respectively), followed by "satisfied" (23.9% and 27.3%, respectively).
Both dosing schedules show acceptable safety profiles for up to 6 months of use when used according to the contraindications in the current prescribing information for standard use (2012) and recent medical literature.
The perinatal consequences of SARS-CoV-2 infection are still largely unknown. This study aimed to describe the features and outcomes of pregnant women with or without SARS-CoV-2 infection after the ...universal screening was established in a large tertiary care center admitting only obstetric related conditions without severe COVID-19 in Mexico City. This retrospective case-control study integrates data between April 22 and May 25, 2020, during active community transmission in Mexico, with one of the highest COVID-19 test positivity percentages worldwide. Only pregnant women and neonates with a SARS-CoV-2 result by quantitative RT-PCR were included in this study. Among 240 pregnant women, the prevalence of COVID-19 was 29% (95% CI, 24% to 35%); 86% of the patients were asymptomatic (95% CI, 76%-92%), nine women presented mild symptoms, and one patient moderate disease. No pregnancy baseline features or risk factors associated with severity of infection, including maternal age > 35 years, Body Mass Index >30 kg/m2, and pre-existing diseases, differed between positive and negative women. The median gestational age at admission for both groups was 38 weeks. All women were discharged at home without complications, and no maternal death was reported. The proportion of preeclampsia was higher in positive women than negative women (18%, 95% CI, 10%-29% vs. 9%, 95% CI, 5%-14%, P<0.05). No differences were found for other perinatal outcomes. SARS-CoV-2 test result was positive for nine infants of positive mothers detected within 24h of birth. An increased number of infected neonates were admitted to the NICU, compared to negative neonates (44% vs. 22%, P<0.05) and had a longer length of hospitalization (2 2-18 days vs. 2 2-3 days, P<0.001); these are potential proxies for illness severity. This report highlights the importance of COVID-19 detection at delivery in pregnant women living in high transmission areas.
COVID-19 symptoms vary widely among pregnant women. We aimed to assess the most frequent symptoms amongst pregnant women with SARS-CoV-2 infection in a tertiary hospital in Mexico City.
A ...cross-sectional study of pregnant women attending the National Institute of Perinatology in Mexico City was performed. All women who attended the hospital, despite their symptoms, were tested for SARS-CoV-2. A multivariate-age-adjusted logistic regression was used to assess the association between the main outcome and each characteristic of the clinical history.
A total of 1880 women were included in the data analysis. Among all women, 30.74% (
= 578) had a positive PCR for SARS-CoV-2 from which 2.7 (
= 50) were symptomatic. Symptoms associated with a positive PCR result were headache (
=.01), dyspnea (
=.043), and myalgia (
=.043).
At universal screening for SARS-CoV-2, one-third of the population had a positive result, while those symptoms associated with a positive PCR were headache, dyspnea, and myalgia.
(1) This study aimed to evaluate characteristics, perinatal outcomes, and placental pathology of pregnant women with or without SARS-CoV-2 infection in the context of maternal PCR cycle threshold ...(CT) values. (2) This was a retrospective case-control study in a third-level health center in Mexico City with universal screening by RT-qPCR. The association of COVID-19 manifestations, preeclampsia, and preterm birth with maternal variables and CT values were assessed by logistic regression models and decision trees. (3) Accordingly, 828 and 298 women had a negative and positive test, respectively. Of those positive, only 2.6% of them presented mild to moderate symptoms. Clinical characteristics between both groups of women were similar. No associations between CT values were found for maternal features, such as pre-gestational BMI, age, and symptomatology. A significantly higher percentage of placental fibrinoid was seen with women with low CTs (<25; p < 0.01). Regarding perinatal outcomes, preeclampsia was found to be significantly associated with symptomatology but not with risk factors or CT values (p < 0.01, aOR = 14.72). Moreover, 88.9% of women diagnosed with COVID-19 at <35 gestational weeks and symptomatic developed preeclampsia. (4) The data support strong guidance for pregnancies with SARS-CoV-2 infection, in particular preeclampsia and placental pathology, which need further investigation.
COVID-19 symptoms vary widely among pregnant women. We aimed to assess the most frequent symptoms amongst pregnant women with SARS-CoV-2 infection in a tertiary hospital in Mexico City.
A ...cross-sectional study of pregnant women attending the National Institute of Perinatology in Mexico City was performed. All women who attended the hospital, despite their symptoms, were tested for SARS-CoV-2. A multivariate-age-adjusted logistic regression was used to assess the association between the main outcome and each characteristic of the clinical history.
A total of 1880 women were included in the data analysis. Among all women, 30.74% (n = 578) had a positive PCR for SARS-CoV-2 from which 2.7 (n = 50) were symptomatic. Symptoms associated with a positive PCR result were headache (p=.01), dyspnea (p=.043), and myalgia (p=.043).
At universal screening for SARS-CoV-2, one-third of the population had a positive result, while those symptoms associated with a positive PCR were headache, dyspnea, and myalgia.
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