256 Participants Needed

Mobile Health Strategy for Premature Birth

Recruiting at 1 trial location
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: Stanford 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?

Preterm births are defined as delivery prior to 37 weeks gestation and account for 35% of infant deaths in the first year of life. 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 who have delivered a preterm infant and who have a short pregnancy interval (time between giving birth and subsequent conception) have an increased risk of preterm birth in subsequent pregnancies. The investigators hope to understand if a mobile health strategy can be used to reduce spontaneous preterm births via improved patient engagement, care coordination, and adherence to recommended care vs a traditional paper-based health strategy.

Will I have to stop taking my current medications?

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

Is the PretermConnect app safe for use in humans?

The PretermConnect app is designed to educate and support mothers of premature babies, and while specific safety data isn't mentioned, it is generally considered safe as it focuses on providing information and support rather than medical treatment.12345

How is the PretermConnect app treatment different from other treatments for premature birth?

The PretermConnect app is unique because it uses mobile technology to educate and support mothers of premature infants, helping them prioritize their health and their babies' health. Unlike traditional treatments, it provides remote monitoring and social support, aiming to reduce social disadvantages and improve outcomes for both mothers and infants.34567

What data supports the effectiveness of the PretermConnect App treatment for premature birth?

Research suggests that mobile apps like PretermConnect can help reduce social disadvantages by providing remote monitoring, social support, and education, which may prevent recurrent premature births and lower infant mortality rates.34567

Who Is on the Research Team?

CJ

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.
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: PretermConnect AppExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

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

Citations

PretermConnect: Leveraging mobile technology to mitigate social disadvantage in the NICU and beyond. [2022]
Mobile applications for prematurity: a systematic review protocol. [2023]
Randomized controlled trial on effectiveness of mHealth (mobile/smartphone) based Preterm Home Care Program on developmental outcomes of preterms: Study protocol. [2019]
Using Digital Communication Technology to Improve Neonatal Care: Two-Part Explorative Needs Assessment. [2023]
Outcome's Classification in Mobile Applications Tailored to Parents of Premature Infants: A Systematic Review. [2023]
Smartphone-based prenatal education for parents with preterm birth risk factors. [2023]
Software development process of Neotree - a data capture and decision support system to improve newborn healthcare in low-resource settings. [2023]
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