Remote Pregnancy Monitoring vs In-Clinic NST for Fetal Monitoring

(REACTIVE Trial)

Overseen By Meaghan McCabe, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Multiple gestations, High BMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of remote pregnancy monitoring with traditional in-clinic nonstress tests (NSTs) for expectant mothers. It tests whether using a special belt at home can increase the likelihood of completing fetal monitoring. Participants will either visit a clinic for their NSTs or use the remote monitoring belt at home. Pregnant individuals carrying a single baby between 30 and 35 weeks, who require regular fetal checks, might be suitable for this trial. As an unphased study, this trial explores innovative monitoring methods that could enhance convenience and comfort for expectant mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that remote pregnancy monitoring is safe for fetal monitoring?

Research has shown that remote pregnancy monitoring is generally safe. The system uses a monitoring belt that accurately detects fetal movements 85% of the time. The FDA has approved this technology, providing an extra level of safety assurance. Studies have found that remote monitoring can reduce the risk of a baby not getting enough oxygen at birth. This indicates that the monitoring is both effective and well-tolerated. Overall, FDA approval and positive research findings support the safety of remote monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote pregnancy monitoring because it offers a convenient alternative to traditional in-clinic non-stress tests (NSTs) for fetal monitoring. Unlike standard in-clinic visits, remote monitoring allows expectant mothers to track their baby's health from home using wearable technology, which can save time and reduce stress. This approach not only provides continuous monitoring but also enhances access to care for those with limited ability to attend frequent clinic appointments. By making fetal health tracking more accessible and less disruptive to daily life, remote monitoring could transform prenatal care.

What evidence suggests that remote pregnancy monitoring is effective for fetal monitoring?

This trial will compare Remote Pregnancy Monitoring with In-Clinic NST for fetal monitoring. Research has shown that remote pregnancy monitoring, which participants in this trial may receive, benefits the baby's health. One study found that it can reduce the risk of the baby not receiving enough oxygen at birth and can also lower healthcare costs compared to traditional methods. Another study demonstrated that remote monitoring can reliably provide clear results for nonstress tests (NSTs) in most appointments. Additionally, remote systems have proven to be 85% accurate in detecting fetal movement, making them useful for long-term home monitoring. These findings suggest that remote monitoring is a promising option for expectant mothers. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking pregnant individuals with a single baby, between 30 and 35 weeks along, who need fetal monitoring based on specific health guidelines. It's not for those with multiple babies, BMI over 45 before pregnancy, pacemakers or defibrillators, skin infections near the belly, abnormal amniotic fluid levels or if they plan to give birth within two weeks.

Inclusion Criteria

English speaking

Singleton pregnancy

Able to provide written consent

Exclusion Criteria

Presence of an implanted pacemaker or defibrillator

Multiple gestations

A known amniotic fluid index (AFI) less than 5cm or greater than 25cm on the most recent ultrasound (if available) prior to randomization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either in-clinic NSTs or use of an FDA-approved remote monitoring belt for pregnancy monitoring

10 weeks

Weekly visits (in-person or remote)

Follow-up

Participants are monitored for obstetrics outcomes and neonatal morbidity post-delivery

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Pregnancy Monitoring

Trial Overview The study compares remote nonstress tests (NST) using an FDA-approved Invu monitoring belt to standard in-clinic NSTs for checking baby's health. Participants will be randomly assigned to one of these two methods to see which is more effective at ensuring tests are completed.

How Is the Trial Designed?

Group I: Remote NST Experimental Treatment 1 Intervention

Group II: In-clinic NST - Standard of Care Active Control 1 Intervention

Remote Pregnancy Monitoring is already approved in United States for the following indications:

Approved in United States as INVU Remote Pregnancy Monitoring System for:

• Remote non-stress testing for pregnant women in their 32nd week of gestation or later with a singleton pregnancy

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The remote fetal monitoring network significantly increased the frequency of non-stress tests (NST) in high-risk pregnancies, leading to better monitoring without increasing costs.

This method resulted in lower rates of neonatal asphyxia (10.3% vs. 20.8%) and preterm birth (12.6% vs. 24.5%) compared to traditional monitoring, while not affecting the cesarean section rates, indicating its efficacy and safety in managing high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical value of remote fetal monitoring network in high-risk pregnancy]. Qi, H., Sun, J., Liu, J., et al.[2006]

A portable fetal monitoring device allows pregnant women to conduct non-stress tests (NST) at home, successfully recording fetal heart rate and uterine contractions, with 82.4% of data transmission errors resolved by users re-examining and resending data.

In a study with 40 participants, the device demonstrated high user satisfaction, with 96% expressing interest in using it again for future pregnancies, indicating its efficacy and acceptance for home monitoring of fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal monitor for non-stress-test screening at home. Horio, H., Murakami, M., Chiba, Y., et al.[2016]

The Non-Stress Test (NST) is a simple and effective preliminary screening tool for high-risk pregnancies, allowing busy practitioners to assess fetal well-being in an office setting.

Despite its utility, the NST has a high false-positive rate and requires further research to establish standardization and 'normal' reactivity, suggesting that more frequent testing may be necessary for certain conditions like diabetes and intrauterine growth restriction (IUGR).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nonstress test. Keegan, KA.[2019]

A pilot study involving 10 low-risk pregnant women demonstrated that remote fetal well-being assessments using self-operated monitoring devices are feasible, with 90% successfully completing the modified biophysical profile (mBPP).

Telemedicine visits were significantly shorter (averaging 93.1 minutes) compared to in-person visits (averaging 247.2 minutes), and participants reported high satisfaction, indicating that this approach could enhance maternal-fetal care efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating technologies to provide comprehensive remote fetal surveillance: A prospective pilot study. Nir, O., Dvir, G., Galler, E., et al.[2023]

Self-nonstress testing for fetal heart rates was found to be reliable and accurate, with 100% of self-test tracings deemed satisfactory for interpretation compared to 90% for assisted tests, based on a study involving 60 patients.

This method not only offers convenience for high-risk mothers by allowing them to monitor fetal health at home but also potentially reduces medical costs by about 50% without compromising the quality of fetal assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of self-nonstress test versus assisted nonstress test in the evaluation of fetal well-being. Reece, EA., Hagay, Z., Garofalo, J., et al.[2019]

A study involving 82 pairs of cardiotocography (CTG) recordings found that self-examinations using mobile devices had an 88.4% agreement with professional examinations, indicating that mobile CTG can be a reliable method for monitoring fetal health.

The remote analysis of CTG recordings showed a 97.1% agreement with on-site evaluations, suggesting that remote pregnancy monitoring is both safe and effective, making it a viable option for routine obstetric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic equivalency of mobile CTG devices and remote analysis to conventional on-site nonstress test. Pilarczyk, R., Strózik, M., Hirnle, L.[2020]

The Non-Stress Test (NST) is a simpler, less invasive, and more cost-effective alternative to the Contraction Stress Test (CST), making it suitable for outpatient settings and use by less skilled personnel.

To ensure the NST remains a reliable diagnostic tool, future studies must clearly define interpretative criteria and include additional fetal heart rate information, as clinical decisions may depend on the accuracy and sensitivity of the test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nonstress test. Reassessment of the "gold standard". Ware, DJ., Devoe, LD.[2018]

In a study of 80 compromised fetuses and 259 healthy controls, the addition of approximate entropy (ApEn) to conventional non-stress testing (NST) criteria significantly improved the sensitivity (91.25%) and predictive values for assessing fetal reactivity.

Using ApEn allowed for a quicker analysis of NST data, enabling healthcare providers to make decisions about fetal reactivity within a single 20-minute window without sacrificing accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of fetal heart rate reactivity from a single 20-min window of non-stress testing in compromised fetuses. Park, YS., Hoh, JK., Koh, SK., et al.[2009]

A study involving 72 high-risk pregnant patients demonstrated that home fetal heart rate monitoring is feasible, with a 93% success rate in transmitting nonstress test (NST) data from home to the hospital.

The majority of the transmitted NSTs (98%) were interpretable, indicating that this method of monitoring is reliable and safe for patients in a tertiary perinatal care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal heart rate monitoring at home and transmission by telephone. Gonen, R., Braithwaite, N., Milligan, JE.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9996419/

Effectiveness of Remote Fetal Monitoring on Maternal-Fetal ... Remote fetal monitoring seems to reduce the incidence of neonatal asphyxia and health care costs compared with routine fetal monitoring.

2. ajog.org ajog.org/article/S0002-9378(23)00809-8/fulltext

Real-world benefits of the INVU remote fetal nonstress ... A pattern of reliability and efficiency emerged, successfully obtaining an interpretable nonstress test (NST) in most appointments.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05847790

Remote Pregnancy Monitoring to Improve Access The goal of this clinical trial is to determine the effectiveness of remote nonstress test (NST) compared to in-clinic NSTs in improving fetal testing ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0301211524006924

Continuous remote home monitoring solutions for mother ... The system showed 85 % accuracy in detecting fetal movement, demonstrating effectiveness for long-term home monitoring. Delay et al. 2021 [28](Tested on 120 ...

5. ajogmfm.org ajogmfm.org/article/S2589-9333(20)30031-8/fulltext

Wireless, remote solution for home fetal and maternal heart ... Remote fetal heart rate (FHR) monitoring may improve access to prenatal care, reduce the burden of clinic visits for pregnant women, and allow for connected ...

6. nuvocares.com nuvocares.com/solutions

Remote Fetal Monitoring | Innovative Care Solutions | INVU ... Experience remote fetal monitoring with INVU by Nuvo, offering convenience and peace of mind for expectant mothers while enhancing maternal care through ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02379351

Use Of An In-Home Non-Stress Test Device For Remote ... Non-stress tests (NSTs) are used to monitor the health of babies during pregnancy. These tests are currently conducted in clinics and hospitals. This requires ...