Clinical Trials Logo

Clinical Trial Summary

Remote postpartum blood pressure monitoring program with text messages has been shown to increase adherence to recommended postpartum blood pressure checks among those with hypertension at discharge from birth hospitalization, but these programs require medically trained professionals to respond to each individual text message. A bluetooth-enabled blood pressure cuff that synchs automatically a smartphone application that leverages Artificial Intelligence to provide tailored recommendations based on recorded blood pressure measurements--and can also provide on-demand education on hypertension--may be less costly way to provide similar support.


Clinical Trial Description

Preeclampsia or gestational hypertension-described as hypertension in pregnancy-affects up to 10% of all pregnancies and is a main driver of maternal morbidity in Rhode Island and the United States. The rates of hypertension in pregnancy have disproportionately affected women of color and may explain why racial minorities have higher maternal morbidity. The American College of Obstetricians and Gynecologists has called for novel interventions to improve health equity and maternal morbidity outcomes among women hypertension in pregnancy. Technology-based interventions (i.e. remote blood pressure monitoring, telehealth visits, text-based communication) have improved access to care but, to date, have not yet demonstrated an effect on reducing maternal morbidity outcomes. It is possible that the lack of effect on maternal morbidity is due to the simplicity of the technology-based interventions previously employed (i.e. text message-based systems). Advanced digital health interventions on blood pressure--namely remote blood pressure monitoring through Bluetooth-enabled blood pressure cuffs and incorporation of a commercially available smartphone application that includes education and patient support as part of a "hypertension in pregnancy pathway"-may more effectively improve perinatal health equity compared to standard SMS-based messaging by reducing perinatal morbidity/mortality among women of color hypertension during their pregnancy. The investigators propose a pilot randomized control trial to examine the feasibility, acceptability, and preliminary estimates of effects of smartphone application-based (app-based) Bluetooth enabled remote blood pressure monitoring (intervention group) when compared to a SMS (short message system such as text message) based remote blood pressure monitoring group (control group). The investigators' long-term goal is to use the most cost-effective intervention (app-based vs SMS-based remote blood pressure monitoring) to improve health equity and maternal morbidity outcomes for pregnant women with hypertension during pregnancy who live in Rhode Island and beyond. The investigators plan to use pilot data from this proposal to support an efficacy trial powered to detect differences in maternal morbidity outcomes between app-based remote blood pressure monitoring and routine care with SMS monitoring. In addition, this proposal stems from a hospital-wide effort at Women & Infants Hospital (WIH) to reduce racial disparities among women of color in terms of frequency of severe maternal morbidity (SMM). SMM is a metric created by the Centers for Disease Control and Prevention that includes blood transfusion as well as adverse outcomes ranging from arrhythmia to eclampsia to intubation. SMM associated with hypertension is driven by asymptomatic postpartum hypertension. This is easily identified and managed prior to becoming SMM when patients adhere to recommended blood pressure checks after discharge. Excluding blood transfusion (which does not pertain to hypertension), the overall rate of SMM among women with hypertension during pregnancy who deliver at WIH is 6.6%. However, there is a significant difference along racial and ethnic lines: the rate of SMM in the setting of hypertension among black women is 6.8% compared to 4.5% among white women, and the rate of SMM in the setting of preeclampsia is 9.4% among Hispanic women compared to 4.9% among non-Hispanic women. The overall dual aim of the initiative is to reduce the disparity in rates of SMM among those with hypertension between black and white women and between Hispanic and non-Hispanic women by at least 33% by December 31, 2022. As part of WIH's equity initiative, automatic blood pressure cuffs (non Bluetooth enabled) will be provided to consenting women with hypertension at discharge from delivery hospitalization as part of routine care. In this study, rates of SMM before the hospital-wide implementation of SMS-based remote blood pressure monitoring will be compared to those after. Thus, for this proposal, this proposal exploring whether app-based remote blood pressure monitoring is required to decrease maternal morbidity compared to standard care with remote SMS blood pressure monitoring. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05595629
Study type Interventional
Source Women and Infants Hospital of Rhode Island
Contact
Status Completed
Phase N/A
Start date November 7, 2022
Completion date August 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT03510286 - Validation of a PrCr Dipstick Diagnostic Test in Ghana
Recruiting NCT03313024 - Berlin-Brandenburg Pregnancy Cohort
Active, not recruiting NCT04990141 - Molecular Screening Method for Preeclampsia (PREMOM)
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT05999851 - Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy N/A
Recruiting NCT02923206 - Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis N/A
Completed NCT02854501 - Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Completed NCT02384226 - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Terminated NCT02558023 - The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine Phase 3
Completed NCT02554604 - Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
Withdrawn NCT05016440 - Lisinopril for Renal Protection in Postpartum Preeclamptic Women N/A
Not yet recruiting NCT02541110 - Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler N/A
Recruiting NCT02337049 - Preeclampsia Subtypes and Surrogate Markers of CVD Risk N/A
Recruiting NCT02247297 - Pancreatic Stone Protein (PSP) in Pregnant Women
Completed NCT02238704 - Cornell University-Micronutrient Initiative Calcium Supplementation Study N/A
Completed NCT01195441 - Prediction and Prevention of Preeclampsia by First Trimester Ultrasound N/A
Withdrawn NCT01179542 - The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR N/A
Completed NCT00456118 - Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Recruiting NCT00117546 - Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia Phase 4
Completed NCT00787241 - Platelet Count Trends in Pre-eclamptic Parturients N/A