Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

NCT04663607 | Completed

• 1 other identifier: 54976
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Interpregnancy interval

  Time interval from most recent birth to next conception

  12-months

Secondary Outcomes (3)

• Breastmilk feeding

  12-months

• Postpartum depression

  12-months

• Mother-infant bonding

  12-months

Study Arms (2)

Control

NO INTERVENTION

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

PretermConnect App

EXPERIMENTAL

Participants will receive health education via a mobile app, PretermConnect

Behavioral: Use of PretermConnect App

Interventions

Use of PretermConnect App BEHAVIORAL

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

PretermConnect App

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: Individuals who have recently delivered a preterm infant
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals with a mobile phone capable of downloading apps from the Apple App Store or Google Play.
• Participants must consent to the study.
• Women whose child is in the neonatal intensive care unit/nursery because the infant was born preterm.
• Women 16-50 years of age
• Women who can read, write and understand English
• Site-specific additional recruitment criteria
• UPMC Children's Hospital of Pittsburgh: Mothers whose babies have been in the neonatal intensive care unit for more than one month.
• UPMC Magee-Womens Hospital: Mothers who have had a preterm baby of \<36 weeks.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• University of Pittsburgh Medical Center: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• C. Jason Wang, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR OF PEDIATRICS (GENERAL PEDIATRICS) AND HEALTH POLICY

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: October 7, 2021
• Primary Completion: June 22, 2025
• Study Completion: July 18, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)