Health and Wellness After Preterm Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-17

Study Completion Date

2025-10-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CCAPB (intervention)

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

Group Type EXPERIMENTAL

Care Coordination after Preterm Birth (CCAPB)

Intervention Type 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.

Usual Care

Usual care participants will not receive the intervention.

Group Type PLACEBO_COMPARATOR

Care Coordination after Preterm Birth (CCAPB)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes