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Behavioural Intervention

Doula Intervention for Postpartum Anxiety (PeliCaN Trial)

N/A
Waitlist Available
Led By Heather Burris, MD MPH
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* HUP postpartum patients who are at least 16 years old at the time their newborns' birth
* Infant born at HUP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

Who is the study for?
This trial is for new mothers experiencing postpartum depression, anxiety, or PTSD after giving birth prematurely. Participants should be from a high-risk, low-income background and will receive care in the NICU of the Hospital of the University of Pennsylvania.
What is being tested?
The study tests a support program involving doulas (trained companions for new mothers) who provide emotional and practical support during and after NICU stay. It's randomized, meaning by chance some get doula support while others don't.
What are the potential side effects?
Since this trial involves non-medical intervention with doula support, there are no direct medical side effects expected. However, participants may experience varying levels of emotional impact due to the nature of personal support.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum
Number of participants who have attendance with a primary care provider by 6 months postpartum
Secondary study objectives
Difference in Depression scores at 6 months postpartum
Receipt of ACOG-recommended postpartum care by patient's designated provider

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Doula InterventionExperimental Treatment1 Intervention
Participants randomized to the intervention will be offered doula support including care coordination to mental and medical health services in the neonatal intensive care unit (NICU), with a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
Group II: ControlActive Control1 Intervention
Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care.

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,043 Previous Clinical Trials
42,889,607 Total Patients Enrolled
Heather Burris, MD MPHPrincipal InvestigatorUniversity of Pennsylvania
~13 spots leftby Aug 2027
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