Clinical Research Directory
Browse clinical research sites, groups, and studies.
Postpartum Care in the NICU Multi-Site
Sponsor: Children's Hospital of Philadelphia
Summary
Parents of infants admitted to the neonatal intensive care unit (NICU) face unique challenges in caring for their own health after giving birth. The demands of having a critically ill infant often make it difficult or impossible to attend postpartum care appointments, and research shows that NICU mothers are significantly more likely than other new mothers to develop postpartum depression and other health conditions, including hypertensive disorders of pregnancy. However, these conditions frequently go undetected and untreated because standard postpartum care systems are not designed to address the needs of NICU mothers, who often prioritize being present in the NICU over their own needs. The PeliCaN (Postpartum Care in the NICU) Multi-Site trial will test whether trained postpartum doulas supporting mothers directly in the NICU can help close postpartum care gaps. Study doulas will provide emotional support, help mothers monitor their blood pressure, screen for postpartum depression, assist with scheduling and attending postpartum care visits, and connect families to community resources while their infant is in the NICU and after discharge for up to 6 months. The study team will enroll approximately 756 mothers across 13 NICUs in the Metro-Philadelphia area. Participating NICUs will be randomly assigned to groups on a stepped-wedge schedule to begin offering the doula intervention. Mothers enrolled before their site begins the doula intervention will receive standard postpartum care and support; mothers enrolled after their site transitions to the intervention period will receive doula support. All participants will complete surveys at enrollment and at 6 months after birth and will have their medical records reviewed. The study's main goals are to determine whether having a doula in the NICU helps mothers to receive recommended comprehensive postpartum care within the first 12 weeks after birth and will assess whether doula support reduces symptoms of postpartum depression and increases maternal transition to primary adult care by 6 months postpartum. The study will also examine the experience of implementing doulas in the NICU across multiple hospital sites among intervention participants and NICU staff members.
Official title: Postpartum Care in the NICU (PeliCaN), a Cluster Randomized Controlled Trial of Doula Support and Healthcare Navigation
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
756
Start Date
2027-01-01
Completion Date
2031-06-30
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Postpartum Doula Support in the NICU
Participants enrolled when sites are active in the intervention period will receive support from a trained postpartum doula embedded in the NICU. Doulas provide in-person emotional support and psychosocial assistance, facilitate maternal blood pressure monitoring and escalation of abnormal readings to obstetric providers, administer the Edinburgh Postnatal Depression Scale (EPDS) at 1, 2, and 4 months postpartum and escalate positive screens to the clinical team, coordinate postpartum healthcare including scheduling and attendance at the postpartum visit, and support care transitions to primary care and cardiology as needed. Doula contact will begin within 3 days of enrollment and continues for 6 months postpartum, with in-person visits and virtual support during the NICU hospitalization and virtual-only support after infant discharge.
Locations (14)
Christiana Hospital
Newark, Delaware, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Children's Hospital of Philadelphia King of Prussia Hospital
King of Prussia, Pennsylvania, United States
Lancaster General Health Women & Babies Hospital
Lancaster, Pennsylvania, United States
Riddle Hospital
Media, Pennsylvania, United States
Jefferson Einstein Montgomery Hospital
Norristown, Pennsylvania, United States
Paoli Hospital
Paoli, Pennsylvania, United States
Lankenau Medical Center
Penn Wynne, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Chester County Hospital
West Chester, Pennsylvania, United States