Remote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).

BACKGROUND: Pregnant women at high risk for developing a hypertensive disorder of pregnancy require frequent antenatal assessments, especially of their blood pressure. This expends significant resources for both the patient and healthcare system. An alternative to in-clinic assessments is a remote blood pressure monitoring strategy, in which patients self-record their blood pressure at home using a validated blood pressure machine. This has the potential to be cost-effective, increase patient satisfaction, and reduce outpatient visits, and has had widespread uptake recently given the increased need for remote care during the ongoing COVID-19 pandemic. However robust evidence supporting this approach over a traditional face-to-face approach is lacking, and the impact on maternal and foetal outcomes has not yet been reported. Thus, there is an urgent need to assess the efficacy of remote monitoring in pregnant women at high risk of developing a hypertensive disorder of pregnancy. METHODS: The REMOTE CONTROL trial is a pragmatic, unblinded, randomised controlled trial, which aims to compare remote blood pressure monitoring in high-risk pregnant women with conventional face-to-face clinic monitoring, in a 1:1 allocation ratio. The study will recruit patients across 3 metropolitan Australian teaching hospitals and will evaluate the safety, cost-effectiveness, impact on healthcare utilisation and end-user satisfaction of remote blood pressure monitoring. DISCUSSION: Remote blood pressure monitoring is garnering interest worldwide and has been increasingly implemented following the COVID-19 pandemic. However, robust data regarding its safety for maternofoetal outcomes is lacking. The REMOTE CONTROL trial is amongst the first randomised controlled trials currently underway, powered to evaluate maternal and foetal outcomes. If proven to be as safe as conventional clinic monitoring, major potential benefits include reducing clinic visits, waiting times, travel costs, and improving delivery of care to vulnerable populations in rural and remote communities. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).

COVID-19 and Hypertensive Disorders of Pregnancy (HDP): A Portuguese Multicentric Retrospective Cohort Study of HDP in SARS-CoV-2 Infected Patients.

BACKGROUND:  An increased incidence of hypertensive disorders of pregnancy (HDP) has been reported among pregnant women infected by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pathogen behind coronavirus disease-19 (COVID-19). Although it is primarily a respiratory infection, the extra-pulmonary manifestations of COVID-19 mimic those found in preeclampsia (PE). Moreover, the two conditions share common risk factors and pathological mechanisms, hindering the ability to understand the interaction between them. Current literature on this topic is controversial and as there is an overlap of clinical and laboratory findings, HDP can be an overreported outcome in pregnant women with COVID-19. The aim of our study is to assess whether there is an association between maternal SARS-CoV-2 infection and HDP. METHODS: We designed a multicenter retrospective cohort study with data collected from five maternity hospitals in Almada, Porto, Lisboa, Penafiel and Coimbra, Portugal, between March 2020 and March 2021. We obtained a sample of 789 pregnant women who were followed up or delivered their babies in one of the participating centers. Each pregnant woman who tested positive for SARS-CoV-2 on a real-time polymerase chain reaction test -- exposure group (n= 263), was paired with two negative pregnant women (1:2), who received the same antenatal care and had similar gestational age and parity -- control group (n=526). Data were collected on maternal characteristics, medical history, obstetric outcomes, and delivery.  Outcomes: The primary outcome of our study is to assess the incidence of HDP in pregnant women infected and not infected by SARS-CoV-2. The secondary outcomes of our study are to assess the incidence of HDP across all COVID-19 severity subgroups and to assess whether SARS-CoV-2 infection in pregnancy modified the odds of a set of risk factors developing HDP.  Results: There was a slightly increased, but not statistically significant, incidence of PE (relative risk, RR, 1.33; 95% confidence interval, CI 0.68-2.57) in the SARS-CoV-2 positive group. There was no statistically significant association between having COVID-19 in pregnancy and developing PE/eclampsia/ hemolysis, elevated liver enzymes, and low platelets, HELLP syndrome [X2(1) = 0.732; p = 0.392] as well as developing gestational hypertension (GH) [X2(1) = 0.039; p = 1]. There was no statistically significant association [X2(2) = 0.402; p = 0.875), [X2(2) = 1.529; p = 0.435] between COVID-19 severity and incidence of HDP. The SARS-CoV-2 infection did not modify the odds of each maternal risk factor causing HDP.  Conclusion: Our study did not demonstrate an association between maternal COVID-19 and HDP. We did not observe a significantly increased incidence of HDP in pregnant women infected by SARS-CoV-2. As current literature is controversial on this topic, clinicians should be aware that HDP is a possible complication of maternal SARS-CoV-2 infection and further research studies urge to better assess the association between COVID-19 in pregnancy and HDP.

A Prospective Analysis of Vitamin D Levels in Pregnant Women Diagnosed with Gestational Hypertension after SARS-CoV-2 Infection.

The great majority of existing studies suggests that the prognosis and outcomes of SARS-CoV-2 infections are improved with adequate vitamin D levels, with or without supplementation. Simultaneously, whether vitamin D supplementation during pregnancy lessens the chance of developing gestational hypertension is controversial. The objective of the present research was to evaluate whether vitamin D levels during pregnancy differ substantially among pregnant women who develop gestational hypertension following SARS-CoV-2 infection. The current research was designed as a prospective cohort following the pregnant women admitted to our clinic with COVID-19 until 36 weeks of gestation. Total vitamin D (25(OH)D) levels were measured in the three study groups in which pregnant women with COVID-19 during pregnancy and a diagnosis of hypertension after 20 weeks of gestation were considered the group of cases (GH-CoV). The second group (CoV) included those with COVID-19 and no hypertension, while the third group (GH) included those with hypertension and no COVID-19. It was observed that 64.4% of SARS-CoV-2 infections in the group of cases occurred during the first trimester, compared to 29.2% in the first trimester among the controls who did not develop GH. Normal vitamin D levels were measured at admission in a significantly higher proportion of pregnant women without GH (68.8% in the CoV group vs. 47.9% in the GH-CoV group and 45.8% in the GH group). At 36 weeks of gestation, the median values of 25(OH)D in the CoV group was 34.4 (26.9-39.7) ng/mL compared to 27.9 (16.2-32.4) ng/mL in the GH-CoV group and 29.5 ng/mL (18.4-33.2) in the GH group, while the blood pressure measurements remained over 140 mmHg among the groups who developed GH. There was a statistically significant negative association between serum 25(OH)D levels and systolic blood pressure (rho = -0.295; p-value = 0.031); however, the risk of developing GH was not significantly higher among pregnant women with COVID-19 if the vitamin D levels were insufficient (OR = 1.19; p-value = 0.092) or deficient (OR = 1.26; p-value = 0.057). Although insufficient or deficient vitamin D among pregnant women with COVID-19 was not an independent risk factor for the development of GH, it is likely that an association between first-trimester SARS-CoV-2 infection and low vitamin D plays a key role in developing gestational hypertension.

Obstetric Emergency Update: Severe Acute Respiratory Syndrome COVID-19 and Hypertension.

The purpose of this article is to bring attention to 2 topics of significant importance to the care of pregnant women and women who have recently given birth. Coronavirus disease 2019 and hypertension can have a significant impact on morbidity and mortality for these pregnant and postpartum women. Although women in their childbearing years are for the most part young and healthy, it is critically important to recognize that these patients have more stringent guidelines for vital signs and laboratory values, which should be noticed as abnormal for rapid treatment as necessary.

Eclampsia and Postpartum Depression in the Setting of Recurrent Prenatal COVID-19.

Current research suggests COVID-19 in pregnancy is associated with poor maternal and fetal outcomes, although the exact mechanisms remain unclear, and the approach to the management of affected patients presents a distinct challenge to clinicians. We present a case of gestational hypertension, eclampsia, and postpartum depression in a 39-year-old gravida 4, para 0030 (G4P0) pregnant patient following multiple prenatal severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infections. After a case of coronavirus disease-19 (COVID-19) during her first trimester, the patient received a two-dose mRNA vaccine against SARS-CoV-2. Despite vaccination, she again contracted COVID-19 during her third trimester of pregnancy. She subsequently developed gestational hypertension at 38 weeks necessitating a cesarean section at 38+4 weeks. The patient delivered a healthy neonate, however, her postpartum course was complicated by eclampsia and postpartum depression. This case bolsters current literature and emphasizes the necessity of continued research into the effects of COVID-19 in pregnant and postpartum women.

Overlapping Presentations of HELLP Syndrome and COVID-19.

Introduction: Haemolysis, elevated liver enzymes and low platelet count (HELLP) syndrome is a leading cause of maternal mortality. The emergence of coronavirus disease 2019 (COVID-19) has led to challenges in diagnosing HELLP syndrome due to overlapping clinical and laboratory presentations. We report a case of HELLP syndrome complicated by COVID-19 infection. Case Description: An otherwise healthy pregnant 31-year-old woman presented with fever, myalgia and headache. She was found to be COVID-positive with laboratory signs of HELLP syndrome. Symptoms and laboratory findings trended toward normal after delivery confirming the diagnosis of HELLP syndrome. Discussion: A prompt diagnosis of HELLP syndrome is essential to avoid maternal and fetal complications. Clinicians should be aware of the similarities in presentation between HELLP syndrome and COVID-19 for timely diagnosis and treatment. LEARNING POINTS: SARS-CoV-2 preferentially binds to ACE2 which is expressed in extrapulmonary tissue including placental tissue.COVID-19, HELLP syndrome and preeclampsia may have similar characteristics including elevated blood pressures, liver dysfunction, cardiopulmonary complaints and hypercoagulability.The temporal relationship of symptomatic improvement with delivery and after delivery may better differentiate HELLP syndrome from COVID-19.

Review of dietary intervention studies that utilized online tools for pregnant or postpartum women

Objective: Due to the prolonged social restrictions implemented during the novel COVID-19 pandemic, there is a need to develop effective dietary intervention methods for pregnant/postpartum women without meeting in-person. We conducted a literature review on online dietary intervention studies on pregnant/postpartum women.

Pregnancy and Birth Outcomes during the Early Months of the COVID-19 Pandemic: The MOACC-19 Cohort.

The new coronavirus, SARS-CoV-2, is devastating for specific groups of patients, but currently there is not enough information concerning its effects on pregnant women. The purpose of this study is to identify the impact of SARS-CoV-2 infection on pregnancy and the consequences that it could cause. We studied a cohort of pregnant ladies who were tested for SARS-CoV-2 infection by RT-PCR and classified as infected or not infected. The recruitment was carried out in the HUMV hospital, a third-level hospital located in Santander, northern Spain. It started on 23 March 2020 and ended on 14 October 2020. Data from our cohort were compared to another cohort recruited in 2018 at the same hospital. We found that gestational hypertension, placental abruptio, and home exposure to an infected person, among other variables, could be associated with SARS-CoV-2 infection. In conclusion, we consider pregnant women a high-risk group of patients towards a possible SARS-CoV-2 infection, especially those who present with conditions such as gestational hypertension or obesity; moreover, we think that SARS-CoV-2 infection could increase the possibilities of having an abruptio placentae, although this result was found in only a few women, so it requires further confirmation.

Preeclampsia and COVID-19: results from the INTERCOVID prospective longitudinal study.

BACKGROUND: It is unclear whether the suggested link between COVID-19 during pregnancy and preeclampsia is an independent association or if these are caused by common risk factors. OBJECTIVE: This study aimed to quantify any independent association between COVID-19 during pregnancy and preeclampsia and to determine the effect of these variables on maternal and neonatal morbidity and mortality. STUDY DESIGN: This was a large, longitudinal, prospective, unmatched diagnosed and not-diagnosed observational study assessing the effect of COVID-19 during pregnancy on mothers and neonates. Two consecutive not-diagnosed women were concomitantly enrolled immediately after each diagnosed woman was identified, at any stage during pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed until hospital discharge using the standardized INTERGROWTH-21st protocols and electronic data management system. A total of 43 institutions in 18 countries contributed to the study sample. The independent association between the 2 entities was quantified with the risk factors known to be associated with preeclampsia analyzed in each group. The outcomes were compared among women with COVID-19 alone, preeclampsia alone, both conditions, and those without either of the 2 conditions. RESULTS: We enrolled 2184 pregnant women; of these, 725 (33.2%) were enrolled in the COVID-19 diagnosed and 1459 (66.8%) in the COVID-19 not-diagnosed groups. Of these women, 123 had preeclampsia of which 59 of 725 (8.1%) were in the COVID-19 diagnosed group and 64 of 1459 (4.4%) were in the not-diagnosed group (risk ratio, 1.86; 95% confidence interval, 1.32-2.61). After adjustment for sociodemographic factors and conditions associated with both COVID-19 and preeclampsia, the risk ratio for preeclampsia remained significant among all women (risk ratio, 1.77; 95% confidence interval, 1.25-2.52) and nulliparous women specifically (risk ratio, 1.89; 95% confidence interval, 1.17-3.05). There was a trend but no statistical significance among parous women (risk ratio, 1.64; 95% confidence interval, 0.99-2.73). The risk ratio for preterm birth for all women diagnosed with COVID-19 and preeclampsia was 4.05 (95% confidence interval, 2.99-5.49) and 6.26 (95% confidence interval, 4.35-9.00) for nulliparous women. Compared with women with neither condition diagnosed, the composite adverse perinatal outcome showed a stepwise increase in the risk ratio for COVID-19 without preeclampsia, preeclampsia without COVID-19, and COVID-19 with preeclampsia (risk ratio, 2.16; 95% confidence interval, 1.63-2.86; risk ratio, 2.53; 95% confidence interval, 1.44-4.45; and risk ratio, 2.84; 95% confidence interval, 1.67-4.82, respectively). Similar findings were found for the composite adverse maternal outcome with risk ratios of 1.76 (95% confidence interval, 1.32-2.35), 2.07 (95% confidence interval, 1.20-3.57), and 2.77 (95% confidence interval, 1.66-4.63). The association between COVID-19 and gestational hypertension and the direction of the effects on preterm birth and adverse perinatal and maternal outcomes, were similar to preeclampsia, but confined to nulliparous women with lower risk ratios. CONCLUSION: COVID-19 during pregnancy is strongly associated with preeclampsia, especially among nulliparous women. This association is independent of any risk factors and preexisting conditions. COVID-19 severity does not seem to be a factor in this association. Both conditions are associated independently of and in an additive fashion with preterm birth, severe perinatal morbidity and mortality, and adverse maternal outcomes. Women with preeclampsia should be considered a particularly vulnerable group with regard to the risks posed by COVID-19.

Effectiveness of a Virtual Exercise Program During COVID-19 Confinement on Blood Pressure Control in Healthy Pregnant Women.

BACKGROUND: The situation caused by COVID-19 has led to movement restrictions for the majority of the population due to the confinement established by the health authorities. This new situation has changed people's habits and significantly affected the pregnant population. Decreased exercise and increased psychophysical stress are associated with excessive weight gain, diabetes, and gestational cardiovascular complications that affect the mother, fetus, and newborn. Recent research shows that the dynamics of maternal blood pressure is one of the most important control factors during pregnancy. Thus, prevention of these type of pathologies through interventions without maternal-fetal risks is important. OBJECTIVES: To examine the influence of a virtual exercise program on maternal blood pressure during pregnancy. MATERIALS AND METHODS: A randomized clinical trial design was used (NCT04563065). Data from 72 pregnant women without obstetric contraindications under confinement conditions in the Madrid area were collected. Women were randomly assigned to the intervention (IG) or control group (CG). They previously signed informed consent forms. A moderate exercise program was performed as an intervention from 8-10 to 38-39 weeks of pregnancy. Systolic (SBP) and diastolic (DBP) maternal blood pressure were measured during the first, second and third trimesters of pregnancy, as well as before and immediately after delivery in both study groups. RESULTS: No differences in systolic and diastolic blood pressure during the first, second and third trimesters were found between groups. Significant differences in SBP were found immediately before delivery (IG = 119.83 ± 10.16 vs. CG = 125.6 ± 10.91; p = 0.047) and immediately after delivery (IG = 115.00 ± 11.18 vs. CG = 122.24 ± 15.71; p = 0.045). CONCLUSIONS: Results show lower SBP values for the IG during delivery than CG. A virtual exercise program throughout pregnancy during COVID-19 confinement can help to control systolic blood pressure before and immediately after delivery in healthy pregnant women.