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Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

Primary Purpose

Preterm Birth

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of PretermConnect App
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • UPMC Magee-Womens Hospital
  • UPMC Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PretermConnect App

Arm Description

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

Participants will receive health education via a mobile app, PretermConnect

Outcomes

Primary Outcome Measures

Interpregnancy interval
Time interval from most recent birth to next conception

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2020
Last Updated
November 17, 2022
Sponsor
Stanford University
Collaborators
University of Pittsburgh Medical Center, Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT04663607
Brief Title
Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth
Official Title
Randomized Controlled Trial Using Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of Pittsburgh Medical Center, Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive paper-based health education as part of standard of care
Arm Title
PretermConnect App
Arm Type
Experimental
Arm Description
Participants will receive health education via a mobile app, PretermConnect
Intervention Type
Behavioral
Intervention Name(s)
Use of PretermConnect App
Intervention Description
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
Primary Outcome Measure Information:
Title
Interpregnancy interval
Description
Time interval from most recent birth to next conception
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Breastmilk feeding
Description
Number of participants feeding baby breastmilk by bottle or breast
Time Frame
12-months
Title
Postpartum depression
Description
Number of participants that screen for postpartum depression
Time Frame
12-months
Title
Mother-infant bonding
Description
Score on mother-infant bonding questionnaire (score range is 10-50; higher scores indicate higher level of bonding)
Time Frame
12-months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Individuals who have recently delivered a preterm infant
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)). Women who have not previously had a preterm birth will be excluded as we are trying to reduce the risk of recurrent preterm birth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Jason Wang, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

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