Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

Not Applicable

• Conditions: Preterm Birth
• Interventions: Behavioral: Use of PretermConnect App

• Registration Number: NCT04663607
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Study Start: 2021-10-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 256

Inclusion Criteria

1. Individuals with a mobile phone capable of downloading apps from the Apple App Store or Google Play.
2. Participants must consent to the study.
3. Women whose child is in the neonatal intensive care unit/nursery because the infant was born preterm.
4. Women 16-50 years of age
5. Women who can read, write and understand English

Site-specific additional recruitment criteria

1. UPMC Children's Hospital of Pittsburgh: Mothers whose babies have been in the neonatal intensive care unit for more than one month.
2. UPMC Magee-Womens Hospital: Mothers who have had a preterm baby of <36 weeks.

Exclusion Criteria

1. 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)).
2. Women who have not previously had a preterm birth will be excluded as we are trying to reduce the risk of recurrent preterm birth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PretermConnect App	Use of PretermConnect App	Participants will receive health education via a mobile app, PretermConnect

Primary Outcome Measures

Name	Time	Method
Interpregnancy interval	12-months	Time interval from most recent birth to next conception

Secondary Outcome Measures

Name	Time	Method
Breastmilk feeding	12-months	Number of participants feeding baby breastmilk by bottle or breast
Mother-infant bonding	12-months	Score on mother-infant bonding questionnaire (score range is 10-50; higher scores indicate higher level of bonding)
Postpartum depression	12-months	Number of participants that screen for postpartum depression

Trial Locations

Locations (2)

UPMC Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States