scholarly journals Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Dorien Lanssens ◽  
◽  
Inge M. Thijs ◽  
Wilfried Gyselaers

Abstract Background Observational data from the retrospective, non-randomized Pregnancy REmote MOnitoring I (PREMOM I) study showed that remote monitoring (RM) may be beneficial for prenatal observation of women at risk for gestational hypertensive disorders (GHD) in terms of clinical outcomes, health economics, and stakeholder perceptions. PREMOM II is a prospective, randomized, multicenter follow-up study that was performed to explore these promising results. Methods After providing written consent, 3922 pregnant women aged ≥18 years who are at increased risk of developing GHD will be randomized (1:1:1 ratio) to (a) conventional care (control group), (b) a patient self-monitoring group, and (c) a midwife-assisted RM group. The women in each group will be further divided (1:1 ratio) to evaluate the outcomes of targeted or non-targeted (conventional) antihypertensive medication. Women will be recruited in five hospitals in Flanders, Belgium: Ziekenhuis Oost-Limburg, Universitaire Ziekenhuis Antwerpen, Universitaire Ziekenhuis Leuven, AZ Sint Jan Brugge–Oostende, and AZ Sint Lucas Brugge. The primary outcomes are: (1) numbers and types of prenatal visits; (2) maternal outcomes; (3) neonatal outcomes; (4) the applicability and performance of RM; and (5) compliance with RM and self-monitoring. The secondary outcomes are: (1) cost-effectiveness and willingness to pay; (2) patient-reported outcome measures (PROMS) questionnaires on the experiences of the participants; and (3) the maternal and perinatal outcomes according to the type of antihypertensive medication. Demographic, and maternal and neonatal outcomes are collected from the patients’ electronic records. Blood pressure and compliance rate will be obtained from an online digital coordination platform for remote data handling. Information about the healthcare-related costs will be obtained from the National Coordination Committee of Belgian Health Insurance Companies (Intermutualistisch Agentschap). PROMS will be assessed using validated questionnaires. Discussion To our knowledge, this is the first randomized trial comparing midwife-assisted RM and self-monitoring of prenatal blood pressure versus conventional management among women at increased risk of GHD. Positive results of this study may lead to a practical framework for caregivers, hospital management, and payers to introduce RM into the prenatal care programs of high-risk pregnancies. Trial registration This study was registered on clinicaltrials.gov, identification number NCT04031430. Registered 24 July 2019, https://clinicaltrials.gov/ct2/show/NCT04031430?cond=premom+ii&draw=2&rank=1.

2017 ◽  
Vol 37 (5) ◽  
pp. 576-578 ◽  
Author(s):  
Susie Q. Lew ◽  
Neal Sikka ◽  
Clinton Thompson ◽  
Teena Cherian ◽  
Manya Magnus

We examined participant uptake and utilization of remote monitoring devices, and the relationship between remote biometric monitoring (RBM) of weight (Wt) and blood pressure (BP) with self-monitoring requirements. Participants on peritoneal dialysis (PD) (n = 269) participated in a Telehealth pilot study of which 253 used remote monitoring of BP and 255 for Wt. Blood pressure and Wt readings were transmitted in real time to a Telehealth call center, which were then forwarded to the PD nurses for real-time review. Uptake of RBM was substantial, with 89.7% accepting RBM, generating 74,266 BP and 52,880 Wt measurements over the study period. We found no significant correlates of RBM uptake with regard to gender, marital, educational, socio-economic or employment status, or baseline experience with computers; frequency of use of BP RBM by Black participants was less than non-Black participants, as was Wt RBM, and participants over 55 years old were more likely to use the Wt RBM than their younger counterparts. Having any review of the breach by a nurse was associated with reduced odds of a subsequent BP breach after adjusting for sex, age, and race. Remote biometric monitoring was associated with adherence to self-monitoring BP and Wt requirements associated with PD. Remote biometric monitoring was feasible, allowing for increased communication between patient and PD clinical staff with real-time patient data for providers to act on to potentially improve adherence and outcomes.


2018 ◽  
Vol 03 (02/03) ◽  
pp. 068-078
Author(s):  
Lalita Nemani

Abstract Hypertension in pregnancy is defined as systolic blood pressure (SBP) ≥ 140 mm Hg or diastolic blood pressure (DBP) ≥ 90 mm Hg or both on two different occasions at least 6 hours apart. Severe hypertension is SBP ≥ 160 mm Hg or DBP ≥ 110 mm Hg. Hypertension is the most common medical problem in pregnancy and one of the major causes of maternal and perinatal mortality and morbidity. Hypertensive disorders in pregnancy (HDP) are classified as (1) chronic hypertension, (2) chronic hypertension with superimposed preeclampsia, (3) preeclampsia-eclampsia, and (4) gestational hypertension. HDP contributes to increased risk of hypertension, stroke, and maternal cardiovascular disease (CVD) in later life. HDP can be considered as a failed cardiovascular stress test identifying women susceptible to CVD in later life. Further research is required to identify the mechanisms in HDP that contribute to CVD in later life so as to initiate appropriate prevention measures.


Hypertension ◽  
2020 ◽  
Vol 75 (6) ◽  
pp. 1439-1446 ◽  
Author(s):  
Chang Seong Kim ◽  
Kyung-Do Han ◽  
Hong Sang Choi ◽  
Eun Hui Bae ◽  
Seong Kwon Ma ◽  
...  

Data regarding health behavior-related factors and systolic or diastolic blood pressure to evaluate the association between blood pressure and kidney cancer are lacking. Using nationally representative data from the Korean National Health Insurance System, 9 746 445 participants without kidney cancer between January 1, 2006 and December 31, 2009 were followed up until December 31, 2017 to obtain data regarding cancer incidence. Participants were categorized, according to blood pressure, as normal (<120/80 mm Hg), elevated (120–129/<80 mm Hg), and hypertensive (≥130/80 mm Hg) with or without antihypertensive medication, according to the 2017 American College of Cardiology and American Heart Association blood pressure guidelines. Kidney cancer was noted in 11 083 participants during the 8-year follow-up. Participants with hypertension were at higher risk for kidney cancer than those without hypertension. Participants with hypertension using medication had a higher cancer risk than those not using medication and those with elevated blood pressure. The risk of kidney cancer significantly increased with higher systolic or diastolic blood pressure, in a dose-dependent manner, even after adjusting for antihypertensive medication use. Therefore, hypertension and high systolic or diastolic blood pressure, compared with normal blood pressure, were associated with an increased risk of kidney cancer.


Hypertension ◽  
2020 ◽  
Vol 76 (6) ◽  
pp. 1945-1952
Author(s):  
Michael E. Ernst ◽  
Enayet K. Chowdhury ◽  
Lawrence J. Beilin ◽  
Karen L. Margolis ◽  
Mark R. Nelson ◽  
...  

High office blood pressure variability (OBPV) in midlife increases the risk of cardiovascular disease (CVD), but the impact of OBPV in older adults without previous CVD is unknown. We conducted a post hoc analysis of ASPREE trial (Aspirin in Reducing Events in the Elderly) participants aged 70-years and older (65 for US minorities) without history of CVD events at baseline, to examine risk of incident CVD associated with long-term, visit-to-visit OBPV. CVD was a prespecified, adjudicated secondary end point in ASPREE. We estimated OBPV using within-individual SD of mean systolic BP from baseline and first 2 annual visits. Cox proportional hazards regression was used to calculate hazard ratios (HR) and 95% CI for associations with CVD events. In 16 475 participants who survived to year 2 without events, those in the highest tertile of OBPV had increased risk of CVD events after adjustment for multiple covariates, when compared with participants in the lowest tertile (HR, 1.36 [95% CI, 1.08–1.70]; P =0.01). Similar increased risk was observed for ischemic stroke (HR, 1.56 [95% CI, 1.04–2.33]; P =0.03), heart failure hospitalization, or death (HR, 1.73 [95% CI, 1.07–2.79]; P =0.02), and all-cause mortality (HR, 1.27 [95% CI, 1.04–1.54]; P =0.02). Findings were consistent when stratifying participants by use of antihypertensive drugs, while sensitivity analyses suggested the increased risk was especially for individuals whose BP was uncontrolled during the OBPV estimation period. Our findings support increased OBPV as a risk factor for CVD events in healthy older adults with, or without hypertension, who have not had such events previously. Registration— URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT01038583; URL: https://www.isrctn.com ; Unique identifiers: ISRCTN83772183.


10.2196/17271 ◽  
2020 ◽  
Vol 8 (8) ◽  
pp. e17271
Author(s):  
Karin Rolanda Jongsma ◽  
Josephus F M van den Heuvel ◽  
Jasmijn Rake ◽  
Annelien L Bredenoord ◽  
Mireille N Bekker

Background Hypertensive disorders of pregnancy (HDP) are a primary cause of adverse maternal and neonatal outcomes worldwide. For women at risk of hypertensive complications, guidelines recommend frequent surveillance of blood pressure and signs of preeclampsia. Clinic visits range from every 2 weeks to several times a week. Given the wide ubiquity of smartphones and computers in most countries and a growing attention for self-management, digital technologies, including mobile health (mHealth), constitute a promising component of monitoring (self-measured) blood pressure during pregnancy. Currently, little is known about the experiences of women using such platforms and how mHealth can be aligned with their needs and preferences. Objective The objectives were twofold: (1) to explore the experiences of Dutch women who had an increased risk of HDP with a blended care approach (mHealth combined with face-to-face care) for remote self-monitoring of blood pressure and preeclampsia symptoms and (2) to formulate recommendations for the use and integration of mHealth in clinical care. Methods Alongside a prospective blended care study (SAFE@home study) that monitors pregnant women at increased risk of HPD with mHealth technology, a mixed methods study was conducted, including questionnaires (n=52) and interviews (n=11). Results were analyzed thematically. Results Of the 4 themes, 2 themes were related to the technologies themselves (expectations, usability), and 2 themes were related to the interaction and use of mHealth (autonomy and responsibilities of patients, responsibilities of health care professionals). First, the digital platform met the expectations of patients, which contributed to user satisfaction. Second, the platform was considered user-friendly, and patients favored different moments and frequencies for measuring their blood pressure. Third, patient autonomy was mentioned in terms of increased insight about their own condition and being able to influence clinical decision making. Fourth, clinical expertise of health care professionals was considered essential to interpret the data, which translates to subsequent responsibilities for clinical management. Data from the questionnaires and interviews corresponded. Conclusions Blended care using an mHealth tool to monitor blood pressure in pregnancy was positively evaluated by its users. Insights from participants led to 7 recommendations for designing and implementing similar interventions and to enhance future, morally sound use of digital technologies in clinical care.


2019 ◽  
Vol 8 (4) ◽  
pp. 435-441 ◽  
Author(s):  
Xiujuan Su ◽  
Yan Zhao ◽  
Zhijuan Cao ◽  
Yingying Yang ◽  
Tony Duan ◽  
...  

Background The effect of isolated maternal hypothyroxinaemia (IMH) on pregnancy complications and neonatal outcomes in human beings is still controversial. Methods This was a retrospective cohort study based on the electronic medical register system. The records of women with a singleton pregnancy who sought antenatal examination between January 2014 and December 2015 at Shanghai First Maternity and Infant Hospital were extracted from the electronic medical records system. Thyroid-stimulating hormone (TSH), free thyroxine (fT4) and anti-thyroperoxidase autoantibody (TPO-Ab) was measured before 20 gestational weeks, and a multiple logistic regression model was used to estimate the odds ratios of pregnancy complications and neonatal outcomes between euthyroid women and those with isolated hypothyroxinaemia. Results A total of 8173 women were included in this study, of whom 342 (4.18%) were diagnosed with IMH. Regression analysis showed that IMH diagnosed in the second trimester (13–20 weeks) was associated with an increased risk of hypertensive disorders of pregnancy (OR = 2.66, 95% CI: 1.38–5.10) and placenta abruption (OR = 3.64, 95% CI: 1.07–12.41), but not with preterm delivery (OR = 1.09, 95% CI: 0.50–2.40), small or large gestational age of infant (OR = 0.91, 95% CI: 0.39–2.12; OR = 1.16, 95% CI: 0.72–1.86), macrosomia (OR = 1.71, 95% CI: 0.95–3.07), gestational diabetes mellitus (OR = 1.36, 95% CI: 0.86–2.15) and placenta previa (OR = 1.62, 95% CI: 0.39–7.37). Conclusion IMH could be a risk factor for hypertensive disorders of pregnancy.


Author(s):  
Michael E. Ernst ◽  
Joanne Ryan ◽  
Enayet K. Chowdhury ◽  
Karen L. Margolis ◽  
Lawrence J. Beilin ◽  
...  

Background Blood pressure variability (BPV) in midlife increases risk of late‐life dementia, but the impact of BPV on the cognition of adults who have already reached older ages free of major cognitive deficits is unknown. We examined the risk of incident dementia and cognitive decline associated with long‐term, visit‐to‐visit BPV in a post hoc analysis of the ASPREE (Aspirin in Reducing Events in the Elderly) trial. Methods and Results ASPREE participants (N=19 114) were free of dementia and significant cognitive impairment at enrollment. Measurement of BP and administration of a standardized cognitive battery evaluating global cognition, delayed episodic memory, verbal fluency, and processing speed and attention occurred at baseline and follow‐up visits. Time‐to‐event analysis using Cox proportional hazards regression models were used to calculate hazard ratios (HR) and corresponding 95% CI for incident dementia and cognitive decline, according to tertile of SD of systolic BPV. Individuals in the highest BPV tertile compared with the lowest had an increased risk of incident dementia and cognitive decline, independent of average BP and use of antihypertensive drugs. There was evidence that sex modified the association with incident dementia (interaction P =0.02), with increased risk in men (HR, 1.68; 95% CI, 1.19–2.39) but not women (HR, 1.01; 95% CI, 0.72–1.42). For cognitive decline, similar increased risks were observed for men and women (interaction P =0.15; men: HR, 1.36; 95% CI, 1.16–1.59; women: HR, 1.14; 95% CI, 0.98–1.32). Conclusions High BPV in older adults without major cognitive impairment, particularly men, is associated with increased risks of dementia and cognitive decline. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01038583; isrctn.com . Identifier: ISRCTN83772183.


2018 ◽  
Vol 37 (2) ◽  
pp. 159-163
Author(s):  
Merita Vuniqi-Krasniqi ◽  
Qëndresë Daka

Introduction: Many studies have demonstrated an increased risk of obstetrical and neonatal complications after assisted reproductive techniques treatment compared to spontaneously conceived pregnancies. There are no data regarding these outcomes in Kosovo. The aim of our study was, to compare maternal, obstetric and neonatal parameters of in-vitro fertilization (IVF) conceived pregnancies complicated with hypertensive disorders (HD) versus uncomplicated spontaneous conceived pregnancies in Kosovo.Material and Methods: This observational study was undertaken at the Department of Gynaecology, University Clinical Centre of Kosova, during a two year period. A total of 104 pregnant women were included in the study. Maternal, obstetrical and neonatal parameters in both groups were assessed and compared. Statistical analysis was performed using SPSS 22.0 statistical software.Results:  that conceived through IVF and had HD during pregnancy were older (p=0.0001), primipara (p=0.007), had multiple pregnancies (p=0.0001) and had worse obstetrical outcomes including cervix insufficiency (p=0.0001), premature rupture of membranes (p=0.0001), and delivery type (p=0.003) compared to women that conceived spontaneously. The only statistically significant differences in neonatal outcomes were in the Apgar1st (p=0.012) and Apgar5th (p=0.004) scores that were higher among babies born from mothers that conceived through IVF and had HD during pregnancy.Conclusions: Results of our study are in line with the results from other countries in regards to maternal demographic profile, except education level and employment, and obstetrical outcomes. However, there were no differences in regards to neonatal outcomes between the two groups of babies other than in the Apgar 1st and Apgar 5th scores.  


2020 ◽  
Vol 33 (7) ◽  
pp. 660-669
Author(s):  
Jan S Erkamp ◽  
Madelon L Geurtsen ◽  
Liesbeth Duijts ◽  
Irwin K M Reiss ◽  
Annemarie G M G J Mulders ◽  
...  

Abstract BACKGROUND Gestational diabetes mellitus is associated with increased risks of gestational hypertension and preeclampsia. We hypothesized that high maternal glucose concentrations in early pregnancy are associated with adverse placental adaptations and subsequently altered uteroplacental hemodynamics during pregnancy, predisposing to an increased risk of gestational hypertensive disorders. METHODS In a population-based prospective cohort study from early pregnancy onwards, among 6,078 pregnant women, maternal early-pregnancy non-fasting glucose concentrations were measured. Mid and late pregnancy uterine and umbilical artery resistance indices were assessed by Doppler ultrasound. Maternal blood pressure was measured in early, mid, and late pregnancy and the occurrence of gestational hypertensive disorders was assessed using hospital registries. RESULTS Maternal early-pregnancy glucose concentrations were not associated with mid or late pregnancy placental hemodynamic markers. A 1 mmol/l increase in maternal early-pregnancy glucose concentrations was associated with 0.71 mm Hg (95% confidence interval 0.22–1.22) and 0.48 mm Hg (95% confidence interval 0.10–0.86) higher systolic and diastolic blood pressure in early pregnancy, respectively, but not with blood pressure in later pregnancy. Also, maternal glucose concentrations were not associated with the risks of gestational hypertension or preeclampsia. CONCLUSIONS Maternal early-pregnancy non-fasting glucose concentrations within the normal range are associated with blood pressure in early pregnancy, but do not seem to affect placental hemodynamics and the risks of gestational hypertensive disorders.


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