2000 Participants NeededMy employer runs this trial

Connected MOM Plus for Pre-eclampsia

EW
SM
Overseen BySherri M Longo, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Tulane University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

EW

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

Plan to deliver at a participating Ochsner hospital
Reside in a zip code served by the participating clinics
Have a participating Ochsner-employed provider
See 2 more

Exclusion Criteria

Provider feels that study participation is not in patient's best interest
Does not understand English or Spanish well enough to follow recommendations
Plans to move from the study area served by the participating clinics

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive support and coaching to use the Connected MOM program during pregnancy

6-9 months
Weekly blood pressure measurements

Postpartum Monitoring

Participants' blood pressure is monitored postpartum, and they attend at least one postpartum visit

4-6 weeks
At least 1 postpartum visit

Follow-up

Participants are monitored for maternal and infant health outcomes after the postpartum period

4 weeks

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

Group I: Intervention - CM+Active Control1 Intervention
Group II: Control - CMActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials
129
Recruited
259,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Ochsner Health System

Collaborator

Trials
97
Recruited
91,900+

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 ...

5.

connectedhealth.ochsner.org

connectedhealth.ochsner.org/connected-mom

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.