Health and Wellness After Preterm Birth

NCT05756634 | Completed

• 2 other identifiers: 21-019198K23HD102560
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Preconception Care; Interconception care; Postpartum care; Preventive health care; Care coordination; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Acceptability of the CCAPB intervention

  Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of \> 3 indicating acceptability.

  up to 6 months

Secondary Outcomes (9)

• Patient reported stress.

  up to 6 months

• Sleep-related impairment

  up to 6 months

• Depression symptoms

  up to 6 months

• Autonomous motivation

  up to 6 months

• Completion of recommended postpartum care

  up to 6 months

Study Arms (2)

CCAPB (intervention)

EXPERIMENTAL

Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.

Behavioral: Care Coordination after Preterm Birth (CCAPB)

Usual Care

PLACEBO COMPARATOR

Usual care participants will not receive the intervention.

Behavioral: Care Coordination after Preterm Birth (CCAPB)

Interventions

Care Coordination after Preterm Birth (CCAPB) BEHAVIORAL

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.

CCAPB (intervention); Usual Care

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Age 14 - 45
• History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may including: low preventive care utilization, tobacco use, obesity, depression or anxiety, history of unmet contraceptive needs, chronic or pregnancy-associated hypertension or diabetes. )
• Intention to seek pediatric care at one of two pediatric primary care sites
• Medicaid insurance

You may not qualify if:

• History of sterilization procedure.
• Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
• Limited English proficiency.
• History of organ failure or malignancies.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Premature Birth; Patient Acceptance of Health Care; Tobacco Use; Contraception Behavior; Depression; Birth Weight

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Reproductive Behavior; Behavioral Symptoms; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Gregory, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 6, 2023
• Study Start: July 17, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)