Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

Trial ID or NCT#

NCT04663607

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 16 Years to 50 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 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. 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.
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Investigator(s)

Paul J. Wang, MD
Paul J. Wang, MD
Cardiac electrophysiologist
John R. and Ai Giak L. Singleton Director, Professor of Medicine (Cardiovascular Medicine) and, by courtesy, of Bioengineering
C. Jason Wang, MD, PhD

View on ClinicalTrials.gov