Telehealth for Maternal Health

Recruiting at 5 trial locations

Overseen By Kacie Simpson, BS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Diabetes, Hypertension, Heart disease, 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: 1

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of providing postpartum care for new mothers. One group will use a telehealth model called Telehealth MOM (Telehealth Multi-Component Optional Model), which includes remote monitoring of blood pressure and temperature, along with a virtual visit with a nurse shortly after birth. The other group will receive enhanced standard care, featuring in-person visits and education on symptoms to watch for. Women between 16-35 weeks pregnant who speak English, Spanish, or Marshallese may be suitable candidates, particularly if they have experienced a healthy pregnancy without serious complications. As an unphased trial, this study offers a unique opportunity to explore innovative postpartum care methods and potentially enhance the postpartum experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Telehealth MOM model is safe for postpartum care?

Research shows that telehealth is generally safe and effective for new mothers after childbirth. Studies have found that using telehealth to monitor conditions like high blood pressure postpartum can be effective without major safety concerns. The Telehealth Multi-Component Optional Model (MOM) includes tools like a blood pressure cuff and thermometer for remote monitoring. This setup allows a nurse to detect problems early by reviewing readings and contacting the patient if necessary. Although specific safety data for this exact model is not yet available, telehealth has been safely used in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Multi-Component Optional Model (MOM) because it offers a proactive and tech-driven approach to postpartum care. Unlike the traditional standard of care, which relies mainly on postpartum visits and patient-initiated contact, Telehealth MOM incorporates daily remote monitoring of vital signs using a blood pressure cuff and thermometer. This allows for early detection of potential health issues and timely interventions, which could improve outcomes for new mothers. Additionally, the inclusion of an early postpartum telehealth visit ensures more immediate support, potentially reducing complications during a critical recovery period.

What evidence suggests that this trial's treatments could be effective for postpartum care?

This trial will compare the Telehealth Multi-Component Optional Model (MOM) with Enhanced Standard of Care (ESoC) for postpartum care. Research has shown that telehealth can ease access to postpartum care for new mothers, especially those who struggle with traditional care. Participants in the Telehealth MOM arm will use telehealth tools, such as monitoring health signs from home and having early online visits, to identify problems sooner. This method enables healthcare providers to monitor factors like blood pressure and respond quickly if needed. Early evidence suggests that telehealth for postpartum care can improve health by providing timely support and information, making it a promising option for new mothers, particularly those who face challenges with in-person visits. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer Callaghan-Koru, PhD

Principal Investigator

University of Arkansas

Pearl McElfish, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-44, between 16-35 weeks gestation, who can communicate in English, Spanish, or Marshallese. It's not for those with certain severe medical conditions like uncontrolled diabetes, end-stage renal disease, ICU stays during pregnancy, or those with mental disabilities affecting decision-making.

Inclusion Criteria

Pregnant women between 16-35 weeks gestation

Participants may have either a vaginal birth or cesarean section birth

Exclusion Criteria

Type 1 diabetes on an insulin pump followed closely by endocrinology

End stage renal disease followed closely by nephrology

Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Postpartum Monitoring

Participants in the Telehealth MOM arm will monitor blood pressure and temperature twice a day for 14 days post-discharge, with remote monitoring by a Registered Nurse.

2 weeks

Remote monitoring

Postpartum Visit

Participants receive a comprehensive postpartum visit around 6 weeks postpartum.

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the postpartum visit.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth Multi-Component Optional Model (MOM)

Trial Overview The study compares two postpartum care models for diverse women: Telehealth MOM, which is a comprehensive telehealth approach, and an enhanced standard of care. It aims to find the best way to deliver postpartum care, especially for racial minorities and rural residents.

How Is the Trial Designed?

Group I: Telehealth MOM Experimental Treatment 1 Intervention

Telehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum.

Group II: Enhanced Standard of Care Active Control 1 Intervention

Enhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers.

Telehealth Multi-Component Optional Model (MOM) is already approved in United States for the following indications:

Approved in United States as Telehealth MOM for:

• Postpartum care
• Maternal health monitoring
• Hypertension management

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Telehealth is increasingly being used in obstetric care, providing essential tools for obstetricians and gynecologists to enhance prenatal, intrapartum, and postpartum care, particularly in rural areas.

It is especially beneficial in the postpartum period for supporting breastfeeding and addressing postpartum depression, improving overall maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth in Maternity Care. Brown, HL., DeNicola, N.[2021]

The implementation of telehealth during the COVID-19 pandemic significantly increased attendance at postpartum visits, with a 90% higher likelihood of attendance compared to the pre-telehealth period (82.9% vs 72.4%).

Telehealth also led to a higher rate of postpartum depression screening (86.3% vs 65.1%), but it was associated with a decrease in the selection of long-acting reversible contraception or permanent sterilization options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact on postpartum care by telehealth: a retrospective cohort study. Arias, MP., Wang, E., Leitner, K., et al.[2023]

A review of 28 randomized controlled trials and 14 observational studies involving 44,894 participants found that telehealth strategies for maternal care generally resulted in similar or better clinical outcomes and patient satisfaction compared to traditional in-person care.

Telehealth interventions, particularly for mental health and diabetes management during pregnancy, were effective in supplementing in-person care, but the impact on health equity and potential harms remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Strategies for the Delivery of Maternal Health Care : A Rapid Review. Cantor, AG., Jungbauer, RM., Totten, AM., et al.[2022]

A survey of postpartum women using telehealth for blood pressure monitoring showed that 95% preferred this remote care method, indicating high acceptability and satisfaction with the technology.

The majority of participants found the telehealth system easy to use and integrate into their lives, with minimal privacy concerns, suggesting it is a safe and effective option for managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perceptions, opinions and satisfaction of telehealth with remote blood pressure monitoring postpartum. Thomas, NA., Drewry, A., Racine Passmore, S., et al.[2022]

A study of 664 pregnant women in Hong Kong revealed that nearly 50% preferred face-to-face consultations over telehealth, with only 12.2% favoring telehealth for routine prenatal checkups, indicating a strong preference for in-person care.

However, acceptance of telehealth increased with gestation and postpartum, particularly for non-physical examination tasks, suggesting that telehealth could be a viable option for certain services, especially if legal concerns are addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and Challenges of Telehealth Obstetric Clinics Among Pregnant Women in Hong Kong: Cross-Sectional Questionnaire Study. Cheung, KW., Au, TS., Wai, JKO., et al.[2023]

Implementing individualized postpartum care with telemedicine during the COVID-19 pandemic significantly increased postpartum contact from 48.0% to 64.6%, indicating improved access to care for new mothers.

While contraceptive use rose dramatically from 49.7% to 84.7% post-intervention, there was a concerning decline in exclusive breastfeeding rates from 75.1% to 46.6%, suggesting a need for enhanced telehealth support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the individualized postpartum care with telemedicine during the COVID-19 pandemic at tertiary hospital in Thailand. Sothornwit, J., Kaewrudee, S., Somboonporn, W., et al.[2023]

Telehealth has significantly improved access to care for pregnant and postpartum women, enhancing education, disease monitoring, and specialty care, which is crucial for addressing social determinants of health (SDOH) that negatively affect their outcomes.

The Moms2B program, designed to reduce disparities in pregnancy outcomes for underserved women, successfully transitioned from in-person to virtual services, demonstrating the effectiveness of telehealth in improving SDOH even before and during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Telehealth Approaches to Address Social Determinants of Health and Improve Pregnancy and Postpartum Outcomes. Dixon-Shambley, K., Gabbe, PT.[2023]

Telehealth is increasingly recognized as a valuable tool in postpartum care, helping to address racial disparities and transportation barriers while improving access to essential health resources.

Key areas where telemedicine is utilized include lactation support, blood pressure monitoring, diabetes screening, mental health services, weight loss programs, and contraception access, highlighting its potential to enhance postpartum health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging as a Means to Engage Patients in the Postpartum Period. Gomez, HB., Hoffman, MK.[2023]

A study involving 19 pregnant women tested the feasibility of using voice technology to deliver perinatal health information through short podcasts, showing promise for improving maternal and infant health outcomes.

Participants highlighted the importance of customization, privacy, and convenience in voice interactions, suggesting that future interventions should focus on accurate, succinct content and allow for family engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Perinatal Health Information via a Voice Interactive App (SMILE): Mixed Methods Feasibility Study. Militello, L., Sezgin, E., Huang, Y., et al.[2021]

Telehealth with remote monitoring significantly reduced postpartum readmissions from 3.7% to 0.5% and improved quality-adjusted life years, indicating its efficacy in managing postpartum hypertensive disorders.

The average cost of telehealth per patient was $309, making it cost-effective compared to standard monitoring, with potential annual savings of approximately $31 million for the healthcare system in the U.S. if implemented widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of telehealth with remote patient monitoring for postpartum hypertension. Niu, B., Mukhtarova, N., Alagoz, O., et al.[2022]

The implementation of a telehealth and education model between two hospitals in southwestern Colombia led to a significant 29% reduction in perinatal mortality rates after the intervention, indicating improved maternal and perinatal care quality.

Additionally, the intervention resulted in fewer cases of postpartum hemorrhage requiring blood transfusions and a decrease in eclampsia rates, showcasing the effectiveness of telemedicine in enhancing obstetric emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of a telehealth and education program with maternal and perinatal outcomes in a low-resource region in Colombia. Escobar, MF., Echavarria, MP., Vasquez, H., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06095960

Telehealth Multi-Component Optional Model (MOM) Study The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40976453/

Protocol for a randomized controlled trial of the telehealth ... The telehealth MOM study: Protocol for a randomized controlled trial of the telehealth multi-component optimal model (MOM) of postpartum care.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06095960/telehealth-multi-component-optional-model-mom-study

Telehealth Multi-Component Optional Model (MOM) Study The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442500076X

Improving maternal postpartum access to care through ... The IMPACT study provides an innovative approach to postpartum care, utilizing telemedicine to enhance access and education for underserved populations.

5. news.uams.edu news.uams.edu/2023/04/19/uams-awarded-15-million-for-study-comparing-approaches-to-postpartum-care/

UAMS Awarded $15 Million for Study Comparing ... The study will compare two postpartum care models — the Telehealth Multicomponent Optimal Model (Telehealth MOM) and enhanced standard of care ...

6. liebertpub.com liebertpub.com/doi/10.1177/15409996251378322

Patterns of Telehealth Use During Pregnancy and ... Objective: This study assesses telehealth use during pregnancy and postpartum among commercially insured women with live birth from 2019 to ...