NCT04663607

Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

Randomized Controlled Trial Using Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The investigators hope to learn how to engage pregnant women at risk for preterm births and reduce the incidence of preterm births through this study. The goal of this study is to reduce the risk of recurrent preterm births for the participating mothers and healthy development of their infants. The investigators hope that this study will accomplish the following for the mothers: Utilize technology to strengthen knowledge of healthy behaviors; Improve adherence to both behavioral and medical interventions that specifically aimed at reducing the risk of spontaneous recurrent preterm births; Develop a platform that can capture participant behavior regarding the participant's lifestyle, environment, social factors, and personal health status; Allow participants to be co-creators of content, thus creating a support network. The investigators hope to achieve improvements in the following primary outcome: Inter-pregnancy interval and the following secondary outcomes: postpartum depression, infant-mother bonding and breast milk feeding between the control and the intervention groups. Ultimately, the investigators hope improvements in these outcomes will improve secondary prevention of preterm births and ultimately reduce infant mortality. Additionally, PretermConnect will monitor mothers on their social circumstances, such as housing and food insecurity, family employment status, and perceived importance of recommended care for the baby's and the participant's own health. The investigators also want to observe if a mobile-delivered health management approach can be more effective than a traditional paper-based health management plan in reducing the incidence of subsequent preterm births amongst individuals who have already had at least one preterm birth.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
BEHAVIORAL	Use of PretermConnect App	Participants will receive health education via a mobile app, PretermConnect, in addition to the standard of care, and complete additional surveys on the social determinants of health

Timeline

• Start date: 2021-10-07
• Primary completion: 2025-06-22
• Completion: 2025-07-18
• First posted: 2020-12-11
• Last updated: 2025-09-24

Locations

2 sites across 1 country: United States