NCT05756634

Health and Wellness After Preterm Birth

Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.

Detailed description

Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within 4 weeks of birth.The primary outcome of this study is acceptability and feasibility of the intervention and study procedures as measured by the Acceptability of Intervention Measure, participant completion of study data collection, and interventionist completion of planned intervention modules.

Conditions

• Preterm Birth
• Health Care Utilization
• Tobacco Use
• Contraceptive Usage
• Depression
• Weight, Birth

Interventions

Type	Name	Description
BEHAVIORAL	Care Coordination after Preterm Birth (CCAPB)	For participants randomized to CCAPB, the care coordinator will follow a manualized intervention to support care planning, health care access, and wellbeing. Contact with participants will be initiated as soon as possible after enrollment, and will continue until six months after enrollment.

Timeline

• Start date: 2023-07-17
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2023-03-06
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States