Doula Support for Postpartum Care

(PeliCaN Trial)

Not yet recruiting at 13 trial locations
HH
KE
Overseen ByKatey E Mari, PhD, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

HH

Heather H Burris, MD, MPH

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for mothers who have just given birth and whose babies are admitted to the NICU in one of 13 hospitals in Metro-Philadelphia. It aims to include those at risk for postpartum depression, anxiety, or high blood pressure after delivery.

Inclusion Criteria

No plans for infant adoption
My baby was born before 34 weeks or has a serious condition needing long NICU care.
Able to communicate in English or Spanish
See 8 more

Exclusion Criteria

Unable to read or sign informed consent for trial participants
If the medical team believes that the infant may die or be transferred to another hospital within 1 week for trial participants
There are no eligibility requirements for this interview.

What Are the Treatments Tested in This Trial?

Interventions

  • Postpartum Doula Support in the NICU

Trial Overview

The study tests if having a trained postpartum doula support mothers directly in the NICU improves their health care after giving birth. Some mothers will get standard care; others will receive extra help from doulas with emotional support, health checks, and connecting to resources.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (Doula Support)Experimental Treatment1 Intervention
Group II: Usual Care (Control)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

Main Line Health

Collaborator

Trials
22
Recruited
6,900+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Thomas Jefferson Health

Collaborator

Virtua Health

Collaborator

Trials
4
Recruited
2,900+