Preterm BirthNCT05756634
Health and Wellness After Preterm Birth
A study testing Care Coordination after Preterm Birth (CCAPB) in people with Preterm Birth and Health Care Utilization, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Health Care Utilization, Tobacco Use
- What is being tested?
- Care Coordination after Preterm Birth (CCAPB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth
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.
Read the 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.
- Conditions
- Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage, Depression, Weight, Birth
- Being tested
- Care Coordination after Preterm Birth (CCAPB)
- Keywords
- Preconception Care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing
- Medical subject headings
- Premature Birth, Patient Acceptance of Health Care, Tobacco Use, Contraception Behavior, Depression, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Coordination after Preterm Birth (CCAPB)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CCAPB (intervention) | Experimental | Intervention participants will receive an intervention focused on health care navigation and motivational enhancement. Receives: Behavioral: Care Coordination after Preterm Birth (CCAPB) |
| Usual Care | Placebo comparator | Usual care participants will not receive the intervention. Receives: Behavioral: Care Coordination after Preterm Birth (CCAPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the CCAPB intervention
Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of > 3 indicating acceptability.
Measured: up to 6 months
Secondary outcomes (9)
Patient reported stress.
Stress will be measured by the validated Perceived Stress Scale (PSS).The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: up to 6 months
Sleep-related impairment
Sleep-related impairment will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment - Short Form 8a.
The Sleep-Related Impairment instrument is a self-reported tool used to document perceived overall sleep-related impairment (or sleep-wake function) over the past seven days. The PROMIS method of scoring uses responses to each item for each participant. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population.
Measured: up to 6 months
Depression symptoms
Depression symptoms will be measured by the Edinburgh Postnatal Depression Scale (EPDS). The 10-question Edinburgh Postnatal Depression Scale (EPDS) is used to identify patients at risk for perinatal depression. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.
Measured: up to 6 months
Autonomous motivation
Autonomous motivation will be measured using the Autonomous Motivation and External Regulation scales of the Treatment Self-Regulation Questionnaire (10 items, range 7 - 70, Cronbach alpha 0.90). This is a self administered questionnaire with a higher score indicating higher emotion regulation strategy.
Measured: up to 6 months
Completion of recommended postpartum care
Completion of recommended postpartum care will be assessed by patient health record review.
Measured: up to 6 months
Contraceptive Use
Contraceptive Use will be measured using an item from the self administered PRAMS questionnaire.
Are you or your husband or partner doing anything now to keep from getting pregnant? No / Yes (if Yes proceed to next)
What kind of birth control are you or your husband using now to keep from getting pregnant?
PRAMS is an ongoing, site-specific, population-based surveillance system designed to identify groups of women and infants at high risk for health problems, to monitor changes in health status, and to measure progress towards goals in improving the health of mothers and infants.
Measured: up to 6 months
Tobacco use
Tobacco use will be assessed by asking participants "Have you smoked any cigarettes in the past 30 days?"
Measured: up to 1 month
Multivitamin use
Multivitamin use will be assessed by asking participants "Are you currently taking a multivitamin?"
Measured: up to 6 months
Autonomy Support
Autonomy support will be measured with the self regulated short form of the Health Care Climate Questionnaire (6 items, range 6 - 42, Cronbach alpha 0.82). Scores on the short form 6-item version are calculated by averaging the individual item scores. Higher average scores represent a higher level of perceived autonomy support.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start17 Jul 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Emily Gregory, MD, MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756634
- Sponsor's protocol ID
- 21-019198
- Other IDs
- K23HD102560
- Status last verified
- Nov 2025
- First submitted
- 20 Feb 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth
- ClinicalTrials.gov ID
- NCT05756634
- Acronym / sponsor ID
- 21-019198
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCAPB (intervention) | Experimental | Behavioral: Care Coordination after Preterm Birth (CCAPB)Intervention participants will receive an intervention focused on health care navigation and motivational enhancement. |
| Usual Care | Placebo comparator | Behavioral: Care Coordination after Preterm Birth (CCAPB)Usual care participants will not receive the intervention. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CCAPB (intervention), Usual Care |
Primary outcome
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.
9 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Gregory, MD, MPH principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination after Preterm Birth (CCAPB) in people with Preterm Birth and Health Care Utilization, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the CCAPB intervention (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.