Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07873190
NA

Postpartum Care in the NICU Multi-Site

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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