Connected MOM Plus for Pre-eclampsia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve the use of a program called Connected MOM Plus, particularly for those facing challenges in accessing healthcare. Connected MOM Plus supports pregnant individuals by focusing on managing pre-eclampsia, a condition that causes high blood pressure during pregnancy. The trial compares two groups: one receives extra help to use Connected MOM Plus, while the other follows the standard approach. Participants may be a good fit if they have access to a smartphone, understand English or Spanish, and plan to deliver at an Ochsner hospital while living nearby.
As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance healthcare access for pregnant individuals.
What prior data suggests that this protocol is safe for improving uptake and utilization of Connected MOM?
Research has shown that the Connected MOM program is generally safe and well-tolerated by participants. One study found that participants in the Connected MOM program were twice as likely to complete important postpartum blood pressure checks compared to those receiving traditional care. Another study demonstrated a 20% reduction in pregnancy complications, such as severe pre-eclampsia (a condition that causes high blood pressure during pregnancy) and early births, when remote blood pressure monitoring was used as part of the Connected MOM approach. These findings suggest that the program is not only safe but also effective in improving pregnancy outcomes.12345
Why are researchers excited about this trial?
Researchers are excited about the Connected MOM Plus for pre-eclampsia because it offers a unique approach by integrating navigator support to help patients enroll and use the Connected MOM program effectively. Unlike traditional management, which may rely heavily on standard prenatal care and medication, this approach emphasizes personalized support and technology to monitor and manage the condition more closely. The potential for improved patient engagement and real-time monitoring could make a significant difference in managing pre-eclampsia, leading to better outcomes for both mothers and babies.
What evidence suggests that Connected MOM Plus is effective for improving healthcare access in pre-eclampsia?
Research has shown that the Connected MOM program can improve health for pregnant women and their babies. One study found that participants were twice as likely to complete important blood pressure checks after giving birth compared to those receiving traditional care. Another study demonstrated that the program reduced early births by 20% by identifying hidden high blood pressure, which is not easily detected. Participants also recorded twice as many blood pressure readings, leading to better monitoring. In this trial, participants in the "Intervention - CM+" arm will receive navigator support to enroll in and use Connected MOM Plus, while those in the "Control - CM" arm will follow the standard protocol for offering Connected MOM. Overall, these findings suggest that Connected MOM Plus could effectively manage pre-eclampsia and improve pregnancy outcomes.13567
Who Is on the Research Team?
Emily W Harville, PhD
Principal Investigator
Tulane University Weatherhead School of Public Health
Are You a Good Fit for This Trial?
This trial is for pregnant or recently postpartum individuals who may be at risk for high blood pressure disorders like preeclampsia, especially those with limited access to healthcare. Specific inclusion and exclusion criteria are not detailed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive support and coaching to use the Connected MOM program during pregnancy
Postpartum Monitoring
Participants' blood pressure is monitored postpartum, and they attend at least one postpartum visit
Follow-up
Participants are monitored for maternal and infant health outcomes after the postpartum period
What Are the Treatments Tested in This Trial?
Interventions
- Connected MOM +
Trial Overview
The study is testing a program called Connected MOM Plus, which helps monitor blood pressure during pregnancy and after birth using remote technology. The goal is to see if this approach improves care compared to usual practices.
How Is the Trial Designed?
2
Treatment groups
Active Control
Navigator support to enroll and use Connected MOM
Standard protocol for offering Connected MOM
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tulane University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Ochsner Health System
Collaborator
Citations
Pre-eclampsia | Nature Reviews Disease Primers
Women who survive pre-eclampsia have reduced life expectancy, with increased risks of stroke, cardiovascular disease and diabetes,
Connected MOM: Taking an Innovative Approach to ...
On average, 30 readings are documented for each individual enrolled in the Connected MOM program, about double the data collected from only in- ...
Implementation Models for Blood Pressure Monitoring in ...
Connected MOM program improves maternal and infant health outcomes. se composite maternal outcome pre-eclampsia without severe features (~5%), ...
New advances in prediction and surveillance of preeclampsia
Preeclampsia affects 3–5% of all pregnant women with an upward trend. has a low positive predictive value to predict preeclampsia-related ...
Ochsner Connected MOM: A Digital Medicine Program
Connected MOM participants were twice as likely to complete a postpartum blood pressure check as women in traditional care.
Health Impacts of Pre-eclampsia: A Comprehensive Analysis ...
Neonatal outcomes included higher rates of preterm birth, low birth weight, and NICU admissions. Long-term mothers with a history of pre- ...
A randomized controlled trial comparing remote blood ...
there was an almost 20 percent decrease in pregnancy complications such as severe preeclampsia and preterm births before 35 weeks' gestation.
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