Health and Wellness After Preterm Birth

Children's Hospital of Philadelphia (CHOP)

Status: Completed

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

Treatments: Behavioral: Care Coordination after Preterm Birth (CCAPB)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05756634

K23HD102560 (U.S. NIH Grant/Contract)

21-019198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups, including a placebo group

CCAPB (intervention)

Experimental group

Description:

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

Treatment:

Behavioral: Care Coordination after Preterm Birth (CCAPB)

Usual Care

Placebo Comparator group

Description:

Usual care participants will not receive the intervention.

Treatment:

Behavioral: Care Coordination after Preterm Birth (CCAPB)