Clinical trial NCT05756634: Health and Wellness After Preterm Birth
Official title: Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-03-06
Enrollment: 96
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of the CCAPB intervention
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient reported stress.
timeFrame: up to 6 months
measure: Sleep-related impairment
timeFrame: up to 6 months
measure: Depression symptoms
timeFrame: up to 6 months
measure: Autonomous motivation
timeFrame: up to 6 months
measure: Completion of recommended postpartum care
timeFrame: up to 6 months
measure: Contraceptive Use
timeFrame: up to 6 months
measure: Tobacco use
timeFrame: up to 1 month
measure: Multivitamin use
timeFrame: up to 6 months
measure: Autonomy Support
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Emily Gregory, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: