Mobile Health Strategy for Premature Birth

No longer recruiting at 1 trial location

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: No mobile phone, No prior preterm birth

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile app, PretermConnect, can reduce the risk of another preterm birth by enhancing health care engagement and care coordination. The trial compares this app-based approach to traditional paper-based health education typically provided to mothers. Women who have had a preterm baby and possess a mobile phone suitable for app downloads may qualify for this study. Participants must also have a child currently in the neonatal intensive care unit or have recently had a preterm baby. As an unphased trial, this study allows participants to contribute to innovative research that could improve future care for mothers and babies.

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 the PretermConnect App is safe for use in reducing preterm births?

Research has shown that mobile apps like PretermConnect are designed to assist and educate mothers of premature babies. While specific safety details for the PretermConnect app are not provided in the studies, mobile health apps are generally considered safe. These apps aim to improve health outcomes without introducing new drugs or complex procedures.

The absence of a specific trial phase for PretermConnect indicates a focus on enhancing patient care and education. This suggests a lower risk of side effects compared to trials involving new medications. Overall, digital tools like PretermConnect are typically well-received and aim to provide support and information to help reduce preterm births. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PretermConnect App because it offers a fresh approach to delivering health education for managing premature birth risks. Unlike the traditional paper-based methods, this app provides information directly to a user's smartphone, making it more accessible and engaging. This digital delivery method allows for real-time updates and personalized content, which could lead to better understanding and adherence to health guidelines for expectant mothers. By leveraging technology, this app has the potential to enhance maternal education in a more efficient and user-friendly way.

What evidence suggests that the PretermConnect App is effective for reducing preterm births?

Studies have shown that mobile health apps like PretermConnect can benefit mothers and their preterm babies. In this trial, one group of participants will receive health education through the PretermConnect app. This app is designed to increase patient involvement and improve care coordination, potentially lowering the risk of another preterm birth. Research indicates that digital tools can better meet the needs of mothers and babies compared to traditional methods. By offering timely health education and support, PretermConnect aims to reduce early births and improve infant survival rates. Overall, early findings suggest that mobile health strategies can help reduce risks associated with preterm births. ^{1 2 3 4 6}

Who Is on the Research Team?

C. Jason Wang, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for women aged 16-50 who have had a preterm infant and own a mobile phone. They must be able to read and understand English, with their child previously in neonatal care due to premature birth. Women without prior preterm births or those without a mobile phone are excluded.

Inclusion Criteria

You have a smartphone that can download apps from the Apple App Store or Google Play.

Participants must consent to the study.

I am a woman aged between 16 and 50.

Exclusion Criteria

Women who have not previously had a preterm birth will be excluded as we are trying to reduce the risk of recurrent preterm birth.

For this initial study, those who do not have a mobile phone will be excluded. (This exclusion will not affect the inclusion of minorities as minorities Internet use via mobile platforms is equal to or greater than whites; hence we are not excluding minorities, based on the PEW Research Center study (PEW Internet Spring Tracking Survey, April 17-May 19, 2013)).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive health education via a mobile app or paper-based strategy to reduce the risk of recurrent preterm births

12 months

Regular virtual check-ins via app or paper-based follow-ups

Follow-up

Participants are monitored for outcomes such as inter-pregnancy interval, postpartum depression, and mother-infant bonding

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Use of PretermConnect App

Trial Overview The study tests the PretermConnect App's effectiveness in reducing recurrent preterm births by enhancing patient engagement, care coordination, and adherence to recommended practices compared to traditional paper-based methods.

How Is the Trial Designed?

Group I: PretermConnect App Experimental Treatment 1 Intervention

Participants will receive health education via a mobile app, PretermConnect

Group II: Control Active Control 1 Intervention

Participants will receive paper-based health education as part of standard of care

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

A study observing 19 consultations between parents of preterm infants and pediatricians identified key communication themes such as breastfeeding, discharge criteria, and medication, highlighting the importance of these topics in parent-pediatrician interactions.

Both parents and pediatricians expressed a strong interest in a neonatal mHealth app that could enhance communication, with desired features including the ability to ask questions, track growth, and access hospital-specific information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Digital Communication Technology to Improve Neonatal Care: Two-Part Explorative Needs Assessment. Tenfelde, K., Antheunis, M., Krahmer, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8923031/

PretermConnect: Leveraging mobile technology to mitigate ... PretermConnect contains features intentionally designed to improve specific outcomes for mothers and their preterm infants. These specific outcomes, which are ...

2. withpower.com withpower.com/trial/phase-premature-birth-9-2021-e4826

Mobile Health Strategy for Premature Birth Trial Overview The study tests the PretermConnect App's effectiveness in reducing recurrent preterm births by enhancing patient engagement, care coordination, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04663607

Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth | ... Early preterm birth are deliveries prior to 32 weeks gestation and account for more than 70% of neonatal deaths and 36.1% of overall infant mortality. Women ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33888330/

PretermConnect: Leveraging mobile technology to mitigate ... Healthcare teams can leverage digital strategies to address maternal and infant needs in this postpartum period, both in the neonatal intensive ...

5. mhealth.amegroups.org mhealth.amegroups.org/article/view/115560/html

Mobile applications to support parents in the transition from ... Apps to support parents of infants in the NICU represent an accessible potential solution to mitigate existing disparities in follow up.

6. healthpolicy.fsi.stanford.edu healthpolicy.fsi.stanford.edu/news/preventing-preterm-deliveries-using-digital-approach

Preventing Preterm Deliveries Using a Digital Approach | FSI PretermConnect uses a digital strategy for prevention and follow-up of preterm births in Allegheny County, PA, to optimize the health and well-being of mothers ...