---
title: Health and Wellness After Preterm Birth
nct_id: NCT05756634
overall_status: COMPLETED
phase: NA
sponsor: "Children's Hospital of Philadelphia"
study_type: INTERVENTIONAL
primary_condition: Preterm Birth
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05756634.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05756634"
ct_last_update_post_date: 2025-11-19
last_seen_at: "2026-05-12T07:23:05.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Health and Wellness After Preterm Birth

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

**NCT ID:** [NCT05756634](https://clinicaltrials.gov/study/NCT05756634)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 67
- **Lead Sponsor:** Children's Hospital of Philadelphia
- **Collaborators:** University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- **Conditions:** Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage, Depression, Weight, Birth
- **Start Date:** 2023-07-17
- **Completion Date:** 2025-10-30
- **CT.gov Last Update:** 2025-11-19

## 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

- **Minimum age:** 14 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **CCAPB (intervention)** (EXPERIMENTAL) — Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.
- **Usual Care** (PLACEBO_COMPARATOR) — Usual care participants will not receive the intervention.

## 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.

## Primary Outcomes

- **Acceptability of the CCAPB intervention** _(time frame: up to 6 months)_ — Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of \> 3 indicating acceptability.

## Secondary Outcomes

- **Patient reported stress.** _(time frame: up to 6 months)_
- **Sleep-related impairment** _(time frame: up to 6 months)_
- **Depression symptoms** _(time frame: up to 6 months)_
- **Autonomous motivation** _(time frame: up to 6 months)_
- **Completion of recommended postpartum care** _(time frame: up to 6 months)_
- **Contraceptive Use** _(time frame: up to 6 months)_
- **Tobacco use** _(time frame: up to 1 month)_
- **Multivitamin use** _(time frame: up to 6 months)_
- **Autonomy Support** _(time frame: up to 6 months)_

## Locations (1)

- Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital of the university of pennsylvania|philadelphia|pennsylvania|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05756634.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05756634*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*