SARS-CoV-2 in Pregnancy-The First Wave.

Background and Objectives: COVID-19, a disease caused by SARS-CoV-2, is a public health emergency. Data on the effect of the virus on pregnancy are limited. Materials and Methods: We carried out a retrospective descriptive study, in order to evaluate the obstetric results on pregnant women in which SARS-CoV-2 was detected through RT-PCR of the nasopharyngeal swab, at admission to the maternity hospital. Results: From 16 March to 31 July 2020, 12 SARS-CoV-2 positive pregnant women have been hospitalized. Eleven were hospitalized for initiation or induction of labor, corresponding to 0.64% of deliveries in the maternity hospital. One pregnant woman was hospitalized for threatened abortion, culminating in a stillbirth at 20 weeks of gestation. Regarding the severity of the disease, nine women were asymptomatic and three had mild illness (two had associated cough and one headache). Three had relevant environmental exposure and a history of contact with infected persons. None had severe or critical illness due to SARS-CoV-2. There were no maternal deaths. The following gestational complications were observed: one stillbirth, one preterm labor, one preterm prelabor rupture of membranes, and one fetal growth restriction. Four deliveries were eutocic, two vacuum-assisted deliveries and five were cesarean sections. The indications for cesarean section were obstetric. Conclusions: SARS-CoV-2 infection was found in a minority of hospitalized pregnant women in this sample. Most are asymptomatic or have mild illness, from gestational complications to highlight stillbirth and preterm birth. There were no cases of vertical transmission by coronavirus.

Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study.

OBJECTIVES: Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH. DESIGN: A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months. SETTING: Three Ghanaian (district, regional) and three Kenyan (levels 4-6) healthcare facilities. PARTICIPANTS: Obstetric staff (n=451) working within participating facilities. INTERVENTION: PPH management training courses were conducted with obstetric staff. PRIMARY AND SECONDARY OUTCOME MEASURES: Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility. RESULTS: All participating hospitals adopted the device during the study period and the majority (52%-62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters. CONCLUSIONS: The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package. TRIAL REGISTRATION NUMBERS: NCT04502173; NCT05340777.

Clinical characteristics, obstetric and perinatal outcome of COVID-19 Infection in pregnant women.

OBJECTIVE: To determine clinical characteristics, obstetrics and perinatal outcome of coronavirus disease 2019 infection in pregnant women. METHODS: The cross-sectional study was conducted at the Department of Obstetrics and Gynaecology of the Ruth Pfau Civil Hospital, Karachi, and Dow University of Health Sciences, Karachi, from August 2020 to July 2021, and comprised pregnant women with suspicion of coronavirus disease 2019 infection, who underwent recommended testing, and were found to be positive. Oral swabs for the presence of infection were also taken from the neonate within 24 hours of delivery. Data was analysed using Stata 11. RESULTS: There were 41 women with a mean age of 27±5 years, a mean gestational age of 35±3 weeks, and mean parity 1.2±1.01. Of them, 3(7.3%) women died. Medical complications found along with coronavirus disease 2019 infection were pregnancy-induced hypertension 2(4.8%), eclampsia 4(11%) and diabetes mellitus 2(4.8%). Fever was the most common symptom seen in 12(30%) women, followed by cough 7(20%) and shortness of breath 6(14%). Majority 32(82%) of the women underwent caesarean section. The most common maternal complication was postpartum haemorrhage 6(20%). Also, 36(86%) women required intensive care unit stay for a mean 5±9 days. CONCLUSIONS: Fever, followed by cough and breathlessness, were the most common clinical features. Most common maternal and foetal complication was postpartum haemorrhage and low birth weight, respectively.

The Intestinal Microbiome, Dietary Habits, and Physical and Psychological Resilience in Postpartum Women (preprint)

The population of postpartum women suffering from mental illness is increasing steadily, particularly under conditions of the COVID-19 pandemic. Identifying factors that contribute to resilience in postpartum women is urgently needed to decrease risks of poor physical and psychological functioning. Studies have linked variations in the intestinal microbiota to depression in clinical samples, but the impacts in postpartum women in a Japanese population are unknown. We conducted two studies to examine the links between intestinal microbiota, physical condition, and psychological state in nonclinical, postpartum Japanese women. Our results show that decreasing Lachnospira and alpha diversity of microbiome is related to high mental health risk (i.e., parenting stress and/or depression). Psychological resilience and physical conditions were associated with relative abundances of genera Blautia, Clostridium, Eggerthella . This study contributes to further understanding of the gut-brain axis mechanisms and supports proposals for interventions to enhance resilience in postpartum women.

Maternal and neonatal safety outcomes after SAR-CoV-2 vaccination during pregnancy: a systematic review and meta-analysis.

BACKGROUND AND OBJECTIVE: More than five million individuals died because of problems connected to COVID-19. SARS-Cov-2 poses a particular challenge to expectant mothers, who comprise one of the most vulnerable segments of the population. Our aim is to demonstrate the maternal and neonatal safety of the COVID-19 vaccine during pregnancy. METHODS: We searched PubMed, Cochrane Library, Scopus, Web of Science (WOS), Embase, Ovid, MedRxiv, and BioRxiv databases from inception till December 2021 and then updated it in April 2022. Additionally, we searched ClinicalTrials.gov, Research Square and grey literature. Cohort, case-control studies, and randomized controlled trials detecting the safety of the Covid-19 vaccine during pregnancy were included. We used the Cochrane tool and Newcastle-Ottawa Scale to assess the risk of bias of the included studies and the GRADE scale to assess the quality of evidence. A meta-analysis was conducted using review manager 5.4. RESULTS: We included 13 studies with a total number of 56,428 patients. Our analysis showed no statistically significant difference in the following outcomes: miscarriage (1.56% vs 0.3%. RR 1.23; 95%CI 0.54 to 2.78); length of maternal hospitalization (MD 0.00; 95%CI -0.08 to 0.08); puerperal fever (1.71% vs 1.1%. RR 1.04; 95%CI 0.67 to 1.61); postpartum hemorrhage (4.27% vs 3.52%. RR 0.84; 95%CI 0.65 to 1.09); instrumental or vacuum-assisted delivery (4.16% vs 4.54%. RR 0.94; 95%CI 0.57 to 1.56); incidence of Apgar score ≤ 7 at 5 min (1.47% vs 1.48%. RR 0.86; 95%CI 0.54 to 1.37); and birthweight (MD -7.14; 95%CI -34.26 to 19.99). CONCLUSION: In pregnancy, the current meta-analysis shows no effect of SAR-CoV-2 vaccination on the risk of miscarriage, length of stay in the hospital, puerperal fever, postpartum hemorrhage, birth weight, or the incidence of an Apgar score of ≤ 7 at 5 min.

HIV and SARS-CoV-2 infection in postpartum Kenyan women and their infants (preprint)

ABSTRACT Background HIV may increase SARS-CoV-2 infection risk and COVID-19 severity generally, but data are limited about its impact on postpartum women and their infants. As such, we characterized SARS-CoV-2 infection among mother-infant pairs in Nairobi, Kenya. Methods We conducted a nested study of 53 HIV-uninfected and 51 healthy women living with HIV, as well as their HIV-exposed uninfected (N=41) and HIV-unexposed (N=48) infants, participating in a prospective cohort. SARS-CoV-2 serology was performed on plasma collected between 1 May-31 December 2020 to determine the incidence, risk factors, and symptoms of infection. SARS-CoV-2 RNA PCR and sequencing was also performed on stool samples from seropositive participants. Results SARS-CoV-2 seropositivity was found in 38% of the 104 mothers and in 17% of the 89 infants. There was no significant association between SARS-CoV-2 infection and maternal HIV (Hazard Ratio [HR]=1.51, 95% CI: 0.780-2.94) or infant HIV exposure (HR=1.48, 95% CI: 0.537-4.09). Maternal SARS-CoV-2 was associated with a >10-fold increased risk of infant infection (HR=10.3, 95% CI: 2.89-36.8). Twenty percent of participants had symptoms, but no participant experienced severe COVID-19 or death. Seroreversion occurred in ∼30% of mothers and infants. SARS-CoV-2 sequences obtained from stool were related to contemporaneously circulating variants. Conclusions These data indicate that postpartum Kenyan women and their infants were at high risk for SARS-CoV-2 infection in 2020, and that antibody responses waned rapidly. However, most cases were asymptomatic and healthy women living with HIV did not have a substantially increased risk of infection or severe COVID-19.

Deferred consent in emergency obstetric research: findings from qualitative interviews with women and recruiters in the ACROBAT pilot trial for severe postpartum haemorrhage.

OBJECTIVE: The ACROBAT pilot trial of early cryoprecipitate for severe postpartum haemorrhage used deferred consent procedures. Pretrial discussions with a patient and public involvement group found mixed views towards deferred consent. This study aimed to build an understanding of how the deferred consent procedures worked in practice, to inform plans for a full-scale trial. SETTING: Qualitative interview study within a cluster-randomised pilot trial, involving four London maternity services. PARTICIPANTS: Individual interviews were conducted postnatally with 10 women who had received blood transfusion for severe postpartum haemorrhage and had consented to the trial. We also interviewed four 'recruiters'-two research midwives and two clinical trials practitioners who conducted trial recruitment. RESULTS: Consent procedures in the ACROBAT pilot trial were generally acceptable and the intervention was viewed as low risk, but most women did not remember much about the consent conversation. As per trial protocol, recruiters sought to consent women before hospital discharge, but this time pressure had to be balanced against the need to ensure women were not approached when distressed or very unwell. Extra efforts had to be made to communicate trial information to women due to the exhaustion of their recovery and competing demands for their attention. Participant information was further complicated by explanations about the cluster design and change in transfusion process, even though the consent sought was for access to medical data. CONCLUSION: Our findings indicate that deferred consent procedures raise similar concerns as taking consent when emergency obstetric research is occurring-that is, the risk that participants may conflate research with clinical care, and that their ability to process trial information may be impacted by the stressful nature of recovery and newborn care. A future trial may support more meaningful informed consent by extending the window of consent discussion and ensuring trial information is minimal and easy to understand. TRIAL REGISTRATION NUMBER: ISRCTN12146519.

Safety of third SARS-CoV-2 vaccine (booster dose) during pregnancy.

BACKGROUND: COVID-19 during pregnancy is associated with adverse outcomes for both the mother and fetus. SARS-CoV-2 vaccination has significantly reduced the risk for symptomatic disease. Several studies have reported on the safety of SARS-CoV-2 vaccination during pregnancy, with no adverse effects on the obstetrical outcomes. However, data regarding the obstetrical outcomes following a booster dose of the SARS CoV-2 vaccination during pregnancy have not yet to be published. OBJECTIVE: This study aimed to examine the association between the booster dose of the SARS CoV-2 vaccination during pregnancy and obstetrical outcomes. STUDY DESIGN: This was a retrospective cohort study of women who delivered between July and October 2021 at a large tertiary medical center. We compared women who received the booster vaccination dose during pregnancy with women who were not vaccinated and with those who only received 2 vaccination doses. Primary outcomes were the incidence of preterm labor and of small for gestational age neonates. Secondary outcomes were other maternal and neonatal complications. A secondary analysis investigating the association between the time from vaccination to delivery and the outcomes was also performed. Multivariable logistic regression models were used to adjust for potential confounders. RESULTS: There were 6507 women who met the inclusion criteria: 294 women received 3 doses of the vaccination, 2845 women received only 2 doses, and 3368 were unvaccinated. Patients receiving 3 doses of the vaccine were older and more likely to smoke than unvaccinated patients. No differences were noted among the triple-vaccinated, twice-vaccinated, and unvaccinated groups with regards to preterm birth and the incidence of small for gestational age neonates. Regarding the secondary outcomes, women in the triple-vaccinated group had higher rates of postpartum hemorrhage (9.5% vs 3.21%; P<.001) and gestational diabetes mellitus (12.2% vs 8.3%; P=.02) and were less likely to have hypertensive disorders of pregnancy (0% vs 1.4%; P=.041) than the unvaccinated group. Compared with the twice-vaccinated patients, patients with 3 doses of the vaccine were more likely to experience postpartum hemorrhage (9.5% vs 3.5%; P<.001) and were less likely to have a low umbilical artery pH (0.7% vs 6.1%; P<.001). In the sensitivity analysis comparing patients who delivered within 2 weeks of the third vaccination dose (n=53) with those who delivered at least 6 weeks after vaccination (n=96), there were no differences in the rates of small for gestational age neonates, preterm birth, postpartum hemorrhage, or cesarean delivery. CONCLUSION: Receiving the booster dose of the SARS-CoV-2 vaccination during pregnancy was not associated with adverse obstetrical outcomes when compared with unvaccinated or twice-vaccinated women. However, higher rates of postpartum hemorrhage were observed. Further studies on a larger scale are needed to confirm these findings.

Association of COVID-19 Vaccination in Pregnancy With Adverse Peripartum Outcomes.

Importance: There is limited comparative epidemiological evidence on outcomes associated with COVID-19 vaccination during pregnancy; monitoring pregnancy outcomes in large populations is required. Objective: To evaluate peripartum outcomes following COVID-19 vaccination during pregnancy. Design, Setting, and Participants: Population-based retrospective cohort study in Ontario, Canada, using a birth registry linked with the provincial COVID-19 immunization database. All births between December 14, 2020, and September 30, 2021, were included. Exposures: COVID-19 vaccination during pregnancy, COVID-19 vaccination after pregnancy, and no vaccination. Main Outcomes and Measures: Postpartum hemorrhage, chorioamnionitis, cesarean delivery (overall and emergency cesarean delivery), admission to neonatal intensive care unit (NICU), and low newborn 5-minute Apgar score (<7). Linear and robust Poisson regression was used to generate adjusted risk differences (aRDs) and risk ratios (aRRs), respectively, comparing cumulative incidence of outcomes in those who received COVID-19 vaccination during pregnancy with those vaccinated after pregnancy and those with no record of COVID-19 vaccination at any point. Inverse probability of treatment weights were used to adjust for confounding. Results: Among 97 590 individuals (mean [SD] age, 31.9 [4.9] years), 22 660 (23%) received at least 1 dose of COVID-19 vaccine during pregnancy (63.6% received dose 1 in the third trimester; 99.8% received an mRNA vaccine). Comparing those vaccinated during vs after pregnancy (n = 44 815), there were no significantly increased risks of postpartum hemorrhage (incidence: 3.0% vs 3.0%; aRD, -0.28 per 100 individuals [95% CI, -0.59 to 0.03]; aRR, 0.91 [95% CI, 0.82-1.02]), chorioamnionitis (0.5% vs 0.5%; aRD, -0.04 per 100 individuals [95% CI, -0.17 to 0.09]; aRR, 0.92 [95% CI, 0.70-1.21]), cesarean delivery (30.8% vs 32.2%; aRD, -2.73 per 100 individuals [95% CI, -3.59 to -1.88]; aRR, 0.92 [95% CI, 0.89-0.95]), NICU admission (11.0% vs 13.3%; aRD, -1.89 per 100 newborns [95% CI, -2.49 to -1.30]; aRR, 0.85 [95% CI, 0.80-0.90]), or low Apgar score (1.8% vs 2.0%; aRD, -0.31 per 100 newborns [95% CI, -0.56 to -0.06]; aRR, 0.84 [95% CI, 0.73-0.97]). Findings were qualitatively similar when compared with individuals who did not receive COVID-19 vaccination at any point (n = 30 115). Conclusions and Relevance: In this population-based cohort study in Ontario, Canada, COVID-19 vaccination during pregnancy, compared with vaccination after pregnancy and with no vaccination, was not significantly associated with increased risk of adverse peripartum outcomes. Study interpretation should consider that the vaccinations received during pregnancy were primarily mRNA vaccines administered in the second and third trimester.

Association of SARS-CoV-2 Infection With Serious Maternal Morbidity and Mortality From Obstetric Complications.

Importance: It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity. Objective: To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications. Design, Setting, and Participants: Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study. All patients with SARS-CoV-2 were included and compared with those without a positive SARS-CoV-2 test result who delivered on randomly selected dates over the same period. Exposures: SARS-CoV-2 infection was based on a positive nucleic acid or antigen test result. Secondary analyses further stratified those with SARS-CoV-2 infection by disease severity. Main Outcomes and Measures: The primary outcome was a composite of maternal death or serious morbidity related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2. The main secondary outcome was cesarean birth. Results: Of the 14 104 included patients (mean age, 29.7 years), 2352 patients had SARS-CoV-2 infection and 11 752 did not have a positive SARS-CoV-2 test result. Compared with those without a positive SARS-CoV-2 test result, SARS-CoV-2 infection was significantly associated with the primary outcome (13.4% vs 9.2%; difference, 4.2% [95% CI, 2.8%-5.6%]; adjusted relative risk [aRR], 1.41 [95% CI, 1.23-1.61]). All 5 maternal deaths were in the SARS-CoV-2 group. SARS-CoV-2 infection was not significantly associated with cesarean birth (34.7% vs 32.4%; aRR, 1.05 [95% CI, 0.99-1.11]). Compared with those without a positive SARS-CoV-2 test result, moderate or higher COVID-19 severity (n = 586) was significantly associated with the primary outcome (26.1% vs 9.2%; difference, 16.9% [95% CI, 13.3%-20.4%]; aRR, 2.06 [95% CI, 1.73-2.46]) and the major secondary outcome of cesarean birth (45.4% vs 32.4%; difference, 12.8% [95% CI, 8.7%-16.8%]; aRR, 1.17 [95% CI, 1.07-1.28]), but mild or asymptomatic infection (n = 1766) was not significantly associated with the primary outcome (9.2% vs 9.2%; difference, 0% [95% CI, -1.4% to 1.4%]; aRR, 1.11 [95% CI, 0.94-1.32]) or cesarean birth (31.2% vs 32.4%; difference, -1.4% [95% CI, -3.6% to 0.8%]; aRR, 1.00 [95% CI, 0.93-1.07]). Conclusions and Relevance: Among pregnant and postpartum individuals at 17 US hospitals, SARS-CoV-2 infection was associated with an increased risk for a composite outcome of maternal mortality or serious morbidity from obstetric complications.

Clinical presentation, pregnancy complications and maternal outcomes of SARS-CoV-2 infection in pregnant women during the third wave of COVID-19 in Mumbai, India (preprint)

Importance: Following the outbreak of SARS-CoV-2 infection, it is unclear whether there is any difference in clinical presentation, disease severity, pregnancy complications, and maternal outcomes in pregnant and postpartum women during the third wave of COVID-19 as compared to the earlier two waves of COVID-19. Objective: To assess the clinical presentation, disease severity, pregnancy complications, and maternal outcomes in women affected with COVID-19 during the third wave in India and compare these parameters with the first wave and second wave of COVID-19. Design: Retrospective observational cohort study Setting: Tertiary care, dedicated COVID-19 hospital catering to Mumbai Metropolitan Region, India Participants: A total of 2,028 pregnant and postpartum women were admitted during three-wave periods: first wave - 1 st April 2020 to 31 st January 2021, second wave - 1 st February 2021 to 10 th December 2021; and third wave - 18 th December 2021 to 19 th January 2022. Exposures: SARS-CoV-2 infection in pregnant and post-partum women confirmed by laboratory confirmation of COVID-19 Main Outcomes and Measures: The primary outcome measures were disease severity, pregnancy complications, and maternal mortality during the third wave compared to the first and second waves of COVID-19. Results: : A total of 2028 pregnant and postpartum women with COVID-19 diagnosis were enrolled during the first, second, and third waves of COVID-19. The hospitalization rate of pregnant and post-partum women with COVID-19 during the first four weeks of the third wave was higher than the earlier two waves as 288 women got admitted within 33 days. The number of SARS-CoV-2 infected pregnant and post-partum women with symptoms of COVID-19 were five times higher during the third wave as compared to the first wave (OR=5.1, 95% CI, 3.8-6.7, pConclusions: and Relevance: Decreased severity of COVID-19 and reduced maternal mortality and morbidity were reported in the third wave as compared to the first wave and second wave of COVID-19 in the Mumbai Metropolitan Region, India. Trial Registration: The study is registered with the Clinical Trial Registry of India (Registration no: CTRI/2020/05/025423).

Obstetrical outcomes and maternal morbidities associated with COVID-19 in pregnant women in France: A national retrospective cohort study.

BACKGROUND: To the best of our knowledge, no study has exhaustively evaluated the association between maternal morbidities and Coronavirus Disease 2019 (COVID-19) during the first wave of the pandemic in pregnant women. We investigated, in natural conceptions and assisted reproductive technique (ART) pregnancies, whether maternal morbidities were more frequent in pregnant women with COVID-19 diagnosis compared to pregnant women without COVID-19 diagnosis during the first wave of the COVID-19 pandemic. METHODS AND FINDINGS: We conducted a retrospective analysis of prospectively collected data in a national cohort of all hospitalizations for births ≥22 weeks of gestation in France from January to June 2020 using the French national hospitalization database (PMSI). Pregnant women with COVID-19 were identified if they had been recorded in the database using the ICD-10 (International Classification of Disease) code for presence of a hospitalization for COVID-19. A total of 244,645 births were included, of which 874 (0.36%) in the COVID-19 group. Maternal morbidities and adverse obstetrical outcomes among those with or without COVID-19 were analyzed with a multivariable logistic regression model adjusted on patient characteristics. Among pregnant women, older age (31.1 (±5.9) years old versus 30.5 (±5.4) years old, respectively, p < 0.001), obesity (0.7% versus 0.3%, respectively, p < 0.001), multiple pregnancy (0.7% versus 0.4%, respectively, p < 0.001), and history of hypertension (0.9% versus 0.3%, respectively, p < 0.001) were more frequent with COVID-19 diagnosis. Active smoking (0.2% versus 0.4%, respectively, p < 0.001) and primiparity (0.3% versus 0.4%, respectively, p < 0.03) were less frequent with COVID-19 diagnosis. Frequency of ART conception was not different between those with and without COVID-19 diagnosis (p = 0.28). When compared to the non-COVID-19 group, women in the COVID-19 group had a higher frequency of admission to ICU (5.9% versus 0.1%, p < 0.001), mortality (0.2% versus 0.005%, p < 0.001), preeclampsia/eclampsia (4.8% versus 2.2%, p < 0.001), gestational hypertension (2.3% versus 1.3%, p < 0.03), postpartum hemorrhage (10.0% versus 5.7%, p < 0.001), preterm birth at <37 weeks of gestation (16.7% versus 7.1%, p < 0.001), <32 weeks of gestation (2.2% versus 0.8%, p < 0.001), <28 weeks of gestation (2.4% versus 0.8%, p < 0.001), induced preterm birth (5.4% versus 1.4%, p < 0.001), spontaneous preterm birth (11.3% versus 5.7%, p < 0.001), fetal distress (33.0% versus 26.0%, p < 0.001), and cesarean section (33.0% versus 20.2%, p < 0.001). Rates of pregnancy terminations ≥22 weeks of gestation, stillbirths, gestational diabetes, placenta praevia, and placenta abruption were not significantly different between the COVID-19 and non-COVID-19 groups. The number of venous thromboembolic events was too low to perform statistical analysis. A limitation of this study relies in the possibility that asymptomatic infected women were not systematically detected. CONCLUSIONS: We observed an increased frequency of pregnant women with maternal morbidities and diagnosis of COVID-19 compared to pregnant women without COVID-19. It appears essential to be aware of this, notably in populations at known risk of developing a more severe form of infection or obstetrical morbidities and in order for obstetrical units to better inform pregnant women and provide the best care. Although causality cannot be determined from these associations, these results may be in line with recent recommendations in favor of vaccination for pregnant women.

Clinical and Epidemiological aspects of SARS-CoV-2 infection among pregnant and postpartum women in Mozambique: a prospective cohort study (preprint)

Background: Although there is a significant increase of evidence regarding the prevalence and impact of COVID-19 on maternal and perinatal outcomes, data on the effects of the pandemic on the obstetric population in sub-Saharan African countries are still scarce. Therefore, the study aims were to assess the prevalence and impact of COVID-19 on maternal and neonatal outcomes in the obstetric population at Central Hospital of Maputo (HCM), Mozambique. Methods Prospective cohort study conducted at teaching and referral maternity, HCM, from 20 October 2020 to 22 July 2021. We collected maternal and perinatal outcomes up to six weeks postpartum of eligible women (pregnant and postpartum women - up to the 14th day postpartum) screened for COVID-19 (individual test for symptomatic participants and pool testing for asymptomatic). The primary outcome was maternal death, SARS and UCI admission. We estimated the COVID-19 prevalence and the unadjusted RR (95% CI) for maternal and perinatal outcomes. We used the chi-square or Fisher's exact test to compare qualitative variables (two-sided p-value 

Opportunities and Challenges for Family-Centered Postpartum Care During the COVID-19 Pandemic: A Qualitative Study of Nurse Perspectives (preprint)

Background: The global COVID-19 pandemic has forced the health care sector to make wide-ranging changes to protect patients as well as providers from the risk of infection. Many of these changes are likely to have greatest impact in contexts of care that employ family-centered models, including perinatal and maternity care. Research conducted in prenatal, childbirth and postpartum settings during the pandemic has shown that some of these restrictions have negatively impacted health care practice and outcomes, while others have been beneficial to both providers and patients. The present qualitative study aimed to understand what changes have occurred in postpartum nursing practice during the pandemic, and how these changes have affected nurses, women and families during their stay in the hospital following a new birth. Methods: Structured interviews were completed with 20 postpartum nurses from five hospitals across Texas. The interview protocol was designed to elicit information about changes to hospital policies in postpartum units during the pandemic, nurses’ attitudes about these changes, perceived benefits and challenges for performance of their duties, and perceived effects on patients and their families. Nurses were recruited for the study using a purposive sampling approach. Interviews were conducted by telephone and lasted approximately 30 to 45 minutes. Data were analyzed using a qualitative descriptive approach. Results: Participants reported that their hospitals placed restrictions on the number and mobility of support persons allowed to stay with the mother in the unit and prohibited all other visitation. Some challenges of these policies included reduced opportunities for hands-on learning and an increased number of patients opting for early discharge. Perceived benefits for nursing practice as well as patient outcomes included improved frequency and effectiveness of nurse-family communication, increased father involvement, and greater opportunities for maternal rest, breastfeeding, skin-to-skin care and family bonding. Conclusions: Study findings suggests that some limitations on postpartum hospital visitation may achieve important, family-centered goals. Protected time for family-bonding, maternal rest, breastfeeding, father involvement and individualized education are critical to quality FCC. Research must examine which visitation policies maximize these benefits while preserving patient access to family and social support.

Comprehensive Evaluation of COVID-19 Patient Short- and Long-term Outcomes: Disparities in Healthcare Utilization and Post-Hospitalization Outcomes (preprint)

BackgroundUnderstanding risk factors for short- and long-term COVID-19 outcomes have implications for current guidelines and practice. We study whether early identified risk factors for COVID-19 persist one year later and through varying disease progression trajectories. MethodsThis was a retrospective study of 6,731 COVID-19 patients presenting to Michigan Medicine between March 10, 2020 and March 10, 2021. We describe disease progression trajectories from diagnosis to potential hospital admission, discharge, readmission, or death. Outcomes pertained to all patients: rate of medical encounters, hospitalization-free survival, and overall survival, and hospitalized patients: discharge versus in-hospital death and readmission. Risk factors included patient age, sex, race, body mass index, and 29 comorbidity conditions. ResultsYounger, non-Black patients utilized healthcare resources at higher rates, while older, male, and Black patients had higher rates of hospitalization and mortality. Diabetes with complications, coagulopathy, fluid and electrolyte disorders, and blood loss anemia were risk factors for these outcomes. Diabetes with complications, coagulopathy, fluid and electrolyte disorders, and blood loss were associated with lower discharge and higher inpatient mortality rates. ConclusionsThis study found differences in healthcare utilization and adverse COVID-19 outcomes, as well as differing risk factors for short- and long-term outcomes throughout disease progression. These findings may inform providers in emergency departments or critical care settings of treatment priorities, empower healthcare stakeholders with effective disease management strategies, and aid health policy makers in optimizing allocations of medical resources.

Universal SARS-CoV-2 Testing for Obstetric Inpatient Units Across the United States (preprint)

Background: The purpose of this study was to estimate prevalence of asymptomatic SARS-CoV-2 infection among patients admitted to obstetric inpatient units throughout the United States as detected by universal screening. We sought to describe the relationship between obstetric inpatient asymptomatic infection rates and publicly available surrounding community infection rates. Methods: This was a cross-sectional study in which medical centers reported rates of positive SARS-CoV-2 testing in asymptomatic pregnant and immediate postpartum patients over a 1-3 month time span in 2020. Publicly reported SARS-CoV-2 case rates from the relevant county and state for each center were collected from the COVID Act Now dashboard and the COVID Tracking Project for correlation analysis. Findings: Data were collected from nine health centers, encompassing 18 hospitals. Participating health centers were located in Alabama, California, Illinois, Louisiana, New Jersey, North Carolina, Pennsylvania, Rhode Island, Utah, and Washington State. Each hospital had an active policy for universal SARS-CoV-2 testing on obstetric inpatient unit. A total of 10,147 SARS-CoV-2 tests were administered, of which 124 were positive (1·2%). Positivity rates varied by site, ranging from 0-3·2%. While SARS-CoV-2 infection rates were lower in asymptomatic obstetric inpatient groups than the surrounding communities, there was a positive correlation between positivity rates in obstetric inpatient units and their surrounding county (p=·003, r=·782) and state (p=·007, r=·708). Interpretation: Given the correlation between community and obstetric inpatient rates, the necessity of SARS-CoV-2 related healthcare resource utilization in obstetric inpatient units may be best-informed by surrounding community infection rates. Funding Information: Internal funding was used.Declaration of Interests: None to declare. Ethics Approval Statement: The study was IRB approved or determined exempt at each center.

COVID-19 vaccination during pregnancy: coverage and safety.

BACKGROUND: Concerns have been raised regarding a potential surge of COVID-19 in pregnancy, secondary to the rising numbers of COVID-19 in the community, easing of societal restrictions, and vaccine hesitancy. Although COVID-19 vaccination is now offered to all pregnant women in the United Kingdom; limited data exist on its uptake and safety. OBJECTIVE: This study aimed to investigate the uptake and safety of COVID-19 vaccination among pregnant women. STUDY DESIGN: This was a cohort study of pregnant women who gave birth at St George's University Hospitals National Health Service Foundation Trust, London, United Kingdom, between March 1, 2020, and July 4, 2021. The primary outcome was uptake of COVID-19 vaccination and its determinants. The secondary outcomes were perinatal safety outcomes. Data were collected on COVID-19 vaccination uptake, vaccination type, gestational age at vaccination, and maternal characteristics, including age, parity, ethnicity, index of multiple deprivation score, and comorbidities. Further data were collected on perinatal outcomes, including stillbirth (fetal death at ≥24 weeks' gestation), preterm birth, fetal and congenital abnormalities, and intrapartum complications. Pregnancy and neonatal outcomes of women who received the vaccine were compared with that of a matched cohort of women with balanced propensity scores. Effect magnitudes of vaccination on perinatal outcomes were reported as mean differences or odds ratios with 95% confidence intervals. Factors associated with antenatal vaccination were assessed with logistic regression analysis. RESULTS: Data were available for 1328 pregnant women of whom 140 received at least 1 dose of the COVID-19 vaccine before giving birth and 1188 women who did not; 85.7% of those vaccinated received their vaccine in the third trimester of pregnancy and 14.3% in the second trimester of pregnancy. Of those vaccinated, 127 (90.7%) received a messenger RNA vaccine and 13 (9.3%) a viral vector vaccine. There was evidence of reduced vaccine uptake in younger women (P=.001), women with high levels of deprivation (ie, fifth quintile of the index of multiple deprivation; P=.008), and women of Afro-Caribbean or Asian ethnicity compared with women of White ethnicity (P<.001). Women with prepregnancy diabetes mellitus had increased vaccine uptake (P=.008). In the multivariable model the fifth deprivation quintile (most deprived) (adjusted odds ratio, 0.10; 95% confidence interval, 0.02-0.10; P=.003) and Afro-Caribbean ethnicity (adjusted odds ratio, 0.27; 95% confidence interval, 0.06-0.85; P=.044) were significantly associated with lower antenatal vaccine uptake, whereas prepregnancy diabetes mellitus was significantly associated with higher antenatal vaccine uptake (adjusted odds ratio, 10.5; 95% confidence interval, 1.74-83.2; P=.014). In a propensity score-matched cohort, the rates of adverse pregnancy outcomes of 133 women who received at least 1 dose of the COVID-19 vaccine in pregnancy were similar to that of unvaccinated pregnant women (P>.05 for all): stillbirth (0.0% vs 0.2%), fetal abnormalities (2.2% vs 2.5%), postpartum hemorrhage (9.8% vs 9.0%), cesarean delivery (30.8% vs 34.1%), small for gestational age (12.0% vs 12.8%), maternal high-dependency unit or intensive care admission (6.0% vs 4.0%), or neonatal intensive care unit admission (5.3% vs 5.0%). Intrapartum pyrexia (3.7% vs 1.0%; P=.046) was significantly increased but the borderline statistical significance was lost after excluding women with antenatal COVID-19 infection (P=.079). Mixed-effects Cox regression showed that vaccination was not significantly associated with birth at <40 weeks' gestation (hazard ratio, 0.93; 95% confidence interval, 0.71-1.23; P=.624). CONCLUSION: Of pregnant women eligible for COVID-19 vaccination, less than one-third accepted COVID-19 vaccination during pregnancy, and they experienced similar pregnancy outcomes with unvaccinated pregnant women. There was lower uptake among younger women, non-White ethnicity, and lower socioeconomic background. This study has contributed to the body of evidence that having COVID-19 vaccination in pregnancy does not alter perinatal outcomes. Clear communication to improve awareness among pregnant women and healthcare professionals on vaccine safety is needed, alongside strategies to address vaccine hesitancy. These strategies include postvaccination surveillance to gather further data on pregnancy outcomes, particularly after first-trimester vaccination, and long-term infant follow-up.

Patient blood management and blood conservation - Complimentary concepts and solutions for blood establishments and clinical services in South Africa and beyond.

Blood transfusions come with risks and high costs, and should be utilized only when clinically indicated. Decisions to transfuse are however not always well informed, and lack of clinician knowledge and education on good clinical transfusion practices contribute to the inappropriate use of blood. Low and middle-income countries in particular take much strain in their efforts to address blood safety challenges, demand-supply imbalances, high blood costs as well as high disease burdens, all of which impact blood usage and blood collections. Patient blood management (PBM), which is a patient-focused approach aimed at improving patient outcomes by preemptively diagnosing and correcting anaemia and limiting blood loss by cell salvage, coagulation optimization and other measures, has become a major approach to addressing many of the challenges mentioned. The associated decrease in the use of blood and blood products may be perceived as being in competition with blood conservation measures, which is the more traditional, but primarily product-focused approach. In this article, we hope to convey the message that PBM and blood conservation should not be seen as competing concepts, but rather complimentary strategies with the common goal of improving patient care. This offers opportunity to improve the culture of transfusion practices with relief to blood establishments and clinical services, not only in South Africa and LMICs, but everywhere. With the COVID-19 pandemic impacting blood supplies worldwide, this is an ideal time to call for educational interventions and awareness as an active strategy to improve transfusion practices, immediately and beyond.

COVID-19 Impacts on Perinatal Care and Maternal Mental Health: A Geotemporal Analysis of Healthcare Disruptions and Emotional Well-Being Across the United States (preprint)

Background: Adequate perinatal care is essential for maternal and infant health. The novel coronavirus (COVID-19) pandemic is potentially the largest natural disruption to perinatal care in recent history, but these disruptions have yet to be characterized in a rigorous and systematic manner. Our goal was to document COVID-19 induced disruptions to perinatal care across the United States (US) using analyses sensitive to the temporal and geographical variability of the pandemic, and to examine the impact of these healthcare disruptions on maternal mental health.Methods: We performed an observational cross-sectional study of 1,922 postpartum and 3,868 pregnant individuals during the 2020 COVID-19 pandemic. Perinatal individuals were recruited from 15 academic institutions across the US, resulting in a geographically diverse sample. We conducted (1) descriptive analyses on the prevalence and timing of perinatal care disruptions, (2) group difference analyses to compare perinatal care disruptions depending on when and where individuals gave birth, (3) cross correlations to assess the temporal linkage between perinatal care disruptions and COVID-19 infection rates, and (4) hierarchical linear regressions to evaluate the impact of prenatal care and birth protocol disruptions on maternal psychological health.Findings: The COVID-19 pandemic significantly altered perinatal care across the US, both through restriction of in-person support and by shifting the focus of care. These changes occurred unevenly over time and across geographic locations. Changes in COVID-19 infection rates explained 65 to 78% of the variance in perinatal care disruptions from August 2019 to August 2020. Moreover, disruptions to perinatal care were robustly associated with heightened psychological distress in mothers, even after controlling for mental health history, number of pregnancy complications, and general stress about the COVID-19 pandemic.Interpretation: Our analyses reveal widespread disruptions to perinatal care across the US that fluctuated depending on where and when individuals gave birth, demonstrating reactivity and elasticity of the US healthcare system. In addition to influencing health outcomes, disruptions to perinatal care may also exacerbate mental health concerns during the COVID-19 pandemic.Funding Information: This research was supported by the NYU COVID-19 Research Catalyst rant, R34DA050287-S1, R34DA050287-S2, R34DA050254-01S2, R01MH126468, R01MH125870, the Nathaniel Wharton Fund, the Columbia University Population Research Center, R34DA050255, R34DA050255-01S2, the Fralin Biomedical Research Institute at VTC, the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Numbers UL1TR003015 and KL2TR003016, the University of Utah Center for Clinical and Translational Science COVID-19 Research Award, Virginia Commonwealth University School of Nursing Internal Grants Program, Sarah P. Farrell Legacy Research Endowment-Virginia Commonwealth University, 5R03HD096141-02, R01HD085990, R34DA050283-01S2, the USC Center for the Changing Family, the Stanford Institute for Research in the Social Sciences, R34DA050291, R01MH119070, R01MH117177, R34 DA050272-01S1, R01 MH113883, R01 DA046224, R21 MH111978, and R21 HD090493, R37 MH10149, UH3OD023279, and National Center for Advancing Translational Sciences (NCATS) Grant UL1TR001881Declaration of Interests: The authors report no conflicts of interest.Ethics Approval Statement: This study has received Institutional Review Board approval from theNYU Langone Health IRB as well as the local IRBs at each data collection site. All data was collected in accordance with the Helsinki Declaration.