Remote Prenatal Care for Pregnancy

Overseen By Rachel Gross, MD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Severe illness, Living in shelter, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28-42 weeks

300 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since conditions like diabetes, hypertension, and depression are not excluded, it seems likely that you can continue with those treatments.

What data supports the effectiveness of the treatment StEP:Prenatal, StEP:Prenatal, Prenatal Starting Early Program mHealth?

Research shows that virtual visits in prenatal care can help improve access to care and maintain patient satisfaction without increasing risks for mothers or babies. Additionally, integrating telemedicine into prenatal care has been recognized as beneficial, especially during the COVID-19 pandemic, by allowing for more personalized and flexible care plans. ^{1 2 3 4 5}

Is remote prenatal care safe for pregnant women?

Research shows that remote prenatal care, especially for low-risk pregnancies, is generally safe and can reduce the number of in-person visits without negative effects on mothers or babies. ^{6 7 8 9 10}

How is the StEP:Prenatal treatment different from other prenatal care options?

StEP:Prenatal is unique because it uses a mobile health (mHealth) approach to provide remote prenatal care, reducing the need for in-person visits and allowing for personalized, risk-appropriate care through virtual monitoring and education, which is especially relevant during situations like the COVID-19 pandemic. ^{3 6 11 12 13}

What is the purpose of this trial?

The purpose of this interventional trial is to test the efficacy of the remote delivery of the StEP:Prenatal intervention compared to standard prenatal care in pregnant individuals planning to receive prenatal and pediatric care at Bellevue Hospital. The primary aims are to determine the efficacy of the remotely delivered StEP:Prenatal intervention on diet, lifestyle behaviors, social determinants of health (SDoH), and pregnancy outcomes.

Research Team

Mary Messito, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for English or Spanish-speaking pregnant individuals in their first trimester, who are at least 18 years old and plan to get prenatal and pediatric care at Bellevue Hospital. They must have a smartphone with internet and be able to consent. Those with severe illnesses, living in shelters, or undergoing substance abuse treatment cannot join.

Inclusion Criteria

Currently pregnant in the first trimester (up to 13 weeks, 6 days)

Willing and able to provide consent

Intent to receive prenatal and pediatric care at Bellevue

Exclusion Criteria

Receiving treatment for drug or alcohol use

Living in a shelter

I have a severe illness, such as cancer or epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine care and up to 8 StEP:Prenatal sessions remotely

28-42 weeks

Remote sessions

Follow-up

Participants are monitored for diet, lifestyle behaviors, and pregnancy outcomes postpartum

6-14 weeks

Self-reported assessments

Treatment Details

Interventions

• StEP:Prenatal

Trial Overview The study is examining the effectiveness of StEP:Prenatal—a remote program focused on improving diet, lifestyle behaviors, social health factors—and its impact on pregnancy outcomes compared to standard prenatal care.

Participant Groups

Group I: Routine Care + StEP:Prenatal Experimental Treatment 2 Interventions

Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period.

Group II: Routine Care Active Control 1 Intervention

Participants will receive routine care during pregnancy and the post-partum period.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Findings from Research

The Virtual Visit model of prenatal care, which combines in-person physician visits with videoconference appointments, does not increase risks for mothers or babies compared to traditional prenatal care, based on a study involving 1,058 low-risk pregnant women.

Women who chose the Virtual Visit track were more likely to be partnered and have previous pregnancies, suggesting this model may be particularly attractive to experienced mothers, while still maintaining similar pregnancy and birth outcomes as traditional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Visits: Managing prenatal care with modern technology. Pflugeisen, BM., McCarren, C., Poore, S., et al.[2017]

The new Michigan Plan for Appropriate Tailored Healthcare in pregnancy (MiPATH) updates prenatal care recommendations to include individualized care plans, telemedicine integration, and consideration of social and structural determinants of health, reflecting changes in care delivery since the COVID-19 pandemic.

The recommendations aim to improve prenatal care by adjusting the number and frequency of visits and monitoring key pregnancy parameters, ultimately enhancing health outcomes for both pregnant patients and their infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Michigan Plan for Appropriate Tailored Healthcare in Pregnancy Prenatal Care Recommendations: A Practical Guide for Maternity Care Clinicians. Peahl, AF., Turrentine, M., Barfield, W., et al.[2022]

A review of 13 studies found that both patients and healthcare providers were highly satisfied with virtual prenatal care visits, noting benefits like cost savings and reduced wait times.

There were no significant differences in clinical outcomes between patients using virtual care and those receiving traditional in-person care, suggesting that virtual visits can effectively complement existing prenatal care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Visits in Prenatal Care: An Integrative Review. Wu, KK., Lopez, C., Nichols, M.[2022]

The Strong Start for Mothers and Newborns initiative, launched by the Centers for Medicare and Medicaid Services, aims to reduce preterm births and low-birth-weight infants among Medicaid beneficiaries through public awareness and enhanced prenatal care models.

Alternative prenatal care models, like home visitation and group prenatal care, are being tested and may offer more effective care compared to traditional medical models, particularly for high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong Start for Mothers and Newborns: implications for prenatal care delivery. Krans, EE., Davis, MM.[2019]

The OB Nest prenatal care model, which includes fewer in-person visits supplemented by virtual connections and home monitoring, aims to maintain or improve patient satisfaction and care continuity for low-risk pregnant women.

This study will evaluate both the effectiveness and feasibility of the OB Nest model compared to standard care, using a mixed-methods approach to gather insights on patient satisfaction, health outcomes, and implementation experiences from both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study. Ridgeway, JL., LeBlanc, A., Branda, M., et al.[2022]

The use of a mobile prenatal care app significantly reduced the average number of in-person obstetric visits for low-risk pregnancies from 10.2 to 7.8 visits, demonstrating its effectiveness in facilitating prenatal care.

Despite the reduction in visits, both patient and provider satisfaction remained unchanged, indicating that the app can maintain quality care while optimizing visit frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. Marko, KI., Ganju, N., Krapf, JM., et al.[2020]

Low-risk pregnant women in the U.S. traditionally have around 14-16 prenatal visits, but evidence supports a reduced visit schedule without adverse effects on maternal or neonatal outcomes.

The reduced frequency of prenatal visits, proposed by an expert panel in 1989, is a significant consideration for healthcare providers and pregnant women, emphasizing the importance of evidence-based prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based prenatal care visits: when less is more. Walker, DS., McCully, L., Vest, V.[2019]

The PREMOM study, involving 91 participants, showed that mothers, midwives, and obstetricians had positive experiences with remote monitoring for high-risk pregnancies, despite most having little prior experience with the technology.

Nearly 72% of mothers reported no issues with taking measurements, and there was strong support for expanding remote monitoring in prenatal care, highlighting its perceived importance in managing hypertensive disorders during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midwives', Obstetricians', and Recently Delivered Mothers' Perceptions of Remote Monitoring for Prenatal Care: Retrospective Survey. Lanssens, D., Vandenberk, T., Lodewijckx, J., et al.[2020]

The PREMOM II study involves 3922 pregnant women at risk for gestational hypertensive disorders, comparing the effectiveness of remote monitoring (RM) and self-monitoring against conventional care, aiming to improve prenatal outcomes.

This is the first randomized trial to assess midwife-assisted RM and self-monitoring for prenatal blood pressure, which could lead to new guidelines for managing high-risk pregnancies if positive results are found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders. Lanssens, D., Thijs, IM., Gyselaers, W.[2021]

In 2017, 57.4% of health centers met the Healthy People 2020 baseline for early prenatal care initiation, indicating that while many centers are performing well, there is still a significant gap in achieving the target of 84.8%.

Factors positively influencing early prenatal care initiation included having a higher proportion of older and privately insured patients, while negative factors included rural location and a higher number of uninsured patients, highlighting areas for targeted improvement in service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of Prenatal Care Initiation in the Health Resources and Services Administration Health Center Program in 2017. Robbins, C., Martocci, S.[2021]

The World Health Organization recommends a minimum of eight prenatal visits during pregnancy to ensure high-quality, personalized care, taking into account the sociocultural context of the patients.

The COVID-19 pandemic has necessitated a shift to telemedicine for prenatal care, allowing healthcare professionals to provide consultations remotely, which helps reduce risks for pregnant women while maintaining access to necessary services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pregnancy care during COVID-19 epidemic, a drive for change?] Baena-Antequera, F., Jurado-García, E., Fernández-Carrasco, FJ., et al.[2020]

A systematic review of 23 studies found that virtual prenatal care is as effective as in-person visits in terms of clinical outcomes, while also offering higher satisfaction rates among pregnant women and healthcare professionals.

Virtual prenatal care significantly reduces travel time and clinic wait times, enhances self-accountability, and is particularly beneficial during situations like a pandemic, making it a valuable option for both low-risk and high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual prenatal care: A systematic review of pregnant women's and healthcare professionals' experiences, needs, and preferences for quality care. Ghimire, S., Martinez, S., Hartvigsen, G., et al.[2023]

A new hybrid low-risk prenatal care protocol was developed for Brazil, combining fewer in-person visits with remote monitoring, which aligns with the Ministry of Health's guidelines.

Pregnant women reported high satisfaction with this hybrid approach, and health outcomes were generally comparable to traditional care, suggesting it could be a safe and effective alternative, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model. Colombo, T., Todeschini, LB., Orlandini, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Virtual Visits: Managing prenatal care with modern technology. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Michigan Plan for Appropriate Tailored Healthcare in Pregnancy Prenatal Care Recommendations: A Practical Guide for Maternity Care Clinicians. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual Visits in Prenatal Care: An Integrative Review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Strong Start for Mothers and Newborns: implications for prenatal care delivery. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Evidence-based prenatal care visits: when less is more. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Midwives', Obstetricians', and Recently Delivered Mothers' Perceptions of Remote Monitoring for Prenatal Care: Retrospective Survey. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Timing of Prenatal Care Initiation in the Health Resources and Services Administration Health Center Program in 2017. [2021]

11. Spain pubmed.ncbi.nlm.nih.gov

[Pregnancy care during COVID-19 epidemic, a drive for change?] [2020]

12. Ireland pubmed.ncbi.nlm.nih.gov

Virtual prenatal care: A systematic review of pregnant women's and healthcare professionals' experiences, needs, and preferences for quality care. [2023]

13. Brazil pubmed.ncbi.nlm.nih.gov

Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model. [2023]