Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04663607
• Other study ID #: 54976
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 256
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	UPMC Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Children's Hospital of Philadelphia, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interpregnancy interval	Time interval from most recent birth to next conception	12-months
Secondary	Breastmilk feeding	Number of participants feeding baby breastmilk by bottle or breast	12-months
Secondary	Postpartum depression	Number of participants that screen for postpartum depression	12-months
Secondary	Mother-infant bonding	Score on mother-infant bonding questionnaire (score range is 10-50; higher scores indicate higher level of bonding)	12-months