An interventional study of Postpartum Doula Support in the NICU in Postpartum, Postpartum Depression (PPD) and Hypertension Disorders in Pregnancy, sponsored by Children's Hospital of Philadelphia. Not yet recruiting at 14 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
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.
Background:
Approximately 10-15% of all births in the United States result in neonatal intensive care unit (NICU) admission annually. Parents of NICU infants face a multitude of stressors that place them at elevated risk for postpartum morbidities and mortality. For example, NICU mothers are 3 to 4 times more likely to develop postpartum depression (PPD) than mothers of well infants, and nearly 3 times more likely to experience hypertensive disorders of pregnancy (HDP), including postpartum preeclampsia, a leading cause of maternal mortality in the United States. The demands of having an infant in the NICU mean that these same mothers are among the least likely to receive timely, comprehensive postpartum care. Evidence shows that NICU mothers attend postpartum visits at substantially lower rates than the general obstetric population, missing the primary opportunity for depression screening, blood pressure monitoring, and connection to ongoing care.
Intervention:
The PeliCaN intervention is a structured postpartum doula support program embedded directly in the NICU. Trained, NICU-informed postpartum doulas will support mothers during the study intervention period in each participating NICU. Doula support will begin within 3 days of enrollment (target: within 10 days of birth) and will continue for 6 months postpartum. During the infant's NICU hospitalization, doula contact will take place in-person at the bedside as well as virtually via phone, text, and video connections. Following infant discharge, support will continue virtually for up to 6 months.
The PeliCaN doula intervention includes: (1) emotional and informational support throughout the NICU stay and transition home; (2) postpartum depression screening using the Edinburgh Postnatal Depression Scale (EPDS) at 1, 2, and 4 months postpartum, with standardized escalation to NICU social workers and obstetric clinicians for any score ≥10 or positive response to Item #10 (suicidal ideation); (3) blood pressure monitoring facilitation in the NICU using validated home BP monitors, with a structured escalation protocol for readings meeting established hypertensive thresholds; and (4) postpartum healthcare coordination, including assistance scheduling and attending postpartum visits, navigating transition to primary care as well as coordinating referrals and visits with cardiology and mental health providers as needed.
Study doulas do not provide clinical care and do not replace any member of the mothers' obstetric clinical team. Rather, doulas serve as a sustained, trusted support person for the mother's own health during a period when maternal needs are routinely deprioritized.
Study Design:
PeliCaN Multi-Site is a type-1 hybrid, effectiveness-implementation stepped-wedge cluster randomized controlled trial. Thirteen NICUs within the Children's Hospital of Philadelphia (CHOP) Newborn Care Network will be randomized into clustered groups of four (two NICUs will be co-randomized). All sites begin in the usual care (control) condition and cross over to the intervention condition at pre-set time points across the study period, such that by the end of the trial all sites will have offered the doula intervention. This design controls for secular trends and allows for within-site pre-post comparisons in addition to between-arm comparisons.
The study is adequately powered, and funded, to enroll approximately 765 participants (378 intervention / 378 usual care) across all sites but are approved to enroll up to 900 participants. Eligible participants are postpartum individuals aged 18 or older with an infant currently hospitalized in a participating NICU, who gave birth at less than 34 weeks gestational age or whose infant has a diagnosis associated with a NICU length of stay of 4 or more weeks, and who are able to communicate in English or Spanish. Participants will be enrolled within 14 days of birth.
Aims:
Aim 1 (Primary Effectiveness): To determine the effectiveness of PeliCaN doula support vs usual care to improve receipt of recommended postpartum healthcare, i.e., (a) screening for depression (EPDS) and (b) screening and management of hypertension (BP) during an infant's NICU hospitalization, as well as (c) attendance at a postpartum visit within 12 weeks.
Aim 2 (Secondary Effectiveness): At 6 months postpartum, to examine effectiveness of PeliCaN vs usual care to (a) decrease depression symptoms and (b) increase transition to primary care clinician or cardiologist for long-term BP management among mothers with hypertensive disorders diagnosed during pregnancy.
Aim 3 (Implementation): To examine the feasibility; (b) acceptability; and (c) fidelity of PeliCaN through mixed methods aimed at understanding perspectives of several key parties (mothers, doulas, NICU staff, and postpartum healthcare clinicians).
Data Collection:
All participants complete a baseline survey at enrollment and a 6-month follow-up survey. Surveys will assess health-related quality of life, social support, healthcare utilization, and demographic and socioeconomic information. Electronic health record data will be abstracted for all participants to confirm postpartum visit attendance and ascertain key covariates including, obstetric diagnoses, medication prescriptions, postpartum care utilization, and infant health information. Doula tracking logs will capture all doula encounters, postpartum depression screening, blood pressure readings, and escalation actions for intervention participants.
Safety Monitoring:
An independent Data Safety Monitoring Board (DSMB) composed of experts in maternal-fetal medicine, perinatal mental health, and biostatistics will review study safety data at biannual meetings. The DSMB will operate under a formal charter and has authority to recommend study modification or early termination if safety concerns arise. The study team will maintain a structured safety monitoring plan with defined escalation procedures for positive EPDS screens and hypertensive emergencies, site-specific clinical escalation contacts, and standardized adverse event reporting to the Institutional Review Board (IRB) and NIH.
536 studies on the registry are indexed under Depression, Postpartum; 126 are open to participants now.
This study's planned enrollment of 756 is above the median of 105 across 430 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Children's Hospital of Philadelphia is the lead sponsor of 488 studies on the registry; 91 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
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Trial Participant Inclusion Criteria:
Semi-Structured Interview Inclusion Criteria:
Trial Participant Exclusion Criteria:
Semi-Structured Interview Exclusion Criteria:
- None
NICU sites during their intervention period. Enrolled participants receive postpartum doula support beginning within 3 days of enrollment and continuing for 6 months postpartum.
Behavioral: Postpartum Doula Support in the NICU
NICU sites during their control period. Enrolled participants receive standard clinical care without study doula support.
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.
Receipt of Comprehensive Postpartum Care (Composite)
The primary outcome is the number of subjects who meet the following definition of positive comprehensive postpartum care receipt assessed across three Yes/No components. All three must be "Yes" for a participant to receive a composite score indicating comprehensive postpartum care was received. 1. Depression screening (EPDS or equivalent) completed at 1, 2, and 4 months postpartum at all timepoints during which the infant remains hospitalized in the NICU. 2. For mothers without HDP: blood pressure check completed within 3-10 days postpartum AND at the standard postpartum visit (4-8 weeks) or for mothers with HDP: adherence to blood pressure monitoring, antihypertensive medication receipt, and follow-up per maternal discharge instructions for the duration of the NICU stay. 3. Attendance at a comprehensive postpartum visit with an obstetric provider within 84 days (12 weeks) of birth, confirmed by electronic health record abstraction and self-report.
Time frame: From birth through 12 weeks postpartum
Secondary Effectiveness Outcome - Long-Term Hypertension Management
Transition to ongoing cardiovascular care (mothers with HDP only): Whether the participant has been connected to an adult primary care provider or cardiologist for ongoing blood pressure management by 6 months postpartum, ascertained by self-report on the 6-month follow-up survey and confirmed by EHR abstraction. Participants will receive a Yes/No score, where "Yes" will indicate that they either attended a healthcare visit with their primary care provider or with a cardiologist by the six-month visit for ongoing hypertension management.
Time frame: From birth through six months postpartum
Secondary Effectiveness Outcome - Depression Symptoms Score
The secondary effectiveness outcome assesses the impact of the PeliCaN doula intervention on longer-term maternal depression symptoms at 6 months. Clinically significant depressive symptoms at 6 months postpartum, measured using the PROMIS Depression 8-item short form administered on the 6-month follow-up survey. The PROMIS Depression short form is a patient-reported measure of depressive symptoms over the past 7 days, each item rated on a 5-point Likert scale (raw score range 8-40) and summed, with raw scores converted to standardized T-scores (range 38.2-81.3) where higher scores indicate greater depression severity.
Time frame: From birth through six months postpartum
Feasibility - Feasibility of Intervention Measure (FIM)
Feasibility will be quantitively assessed via stakeholder perceptions of intervention suitability for everyday use in the NICU, measured using the Feasibility of Intervention Measure (FIM), a validated 4-item self-report scale scored on a 5-point Likert scale (mean score range 1-5; higher scores indicate greater perceived feasibility), administered via structured survey to doulas, NICU nurses, and obstetric clinicians at each participating site. Results will be complimented by semi-structured qualitative interviews with a purposive sample of participants, doulas, and site clinical leaders.
Time frame: Birth to end of study, approximately 3 years
Feasibility - Average Enrollment
Feasibility will be assessed by measuring the average time spent by each doula per enrolled mother per week, in minutes, derived from the Doula Tracking Log across the 6-month intervention period. Doula time spent with participants will be examined by site and by respondent role.
Time frame: From birth to end of study, approximately 3 years
Acceptability of the PeliCaN Doula Intervention (AIM)
Acceptability assessed using the Acceptability of Intervention Measure (AIM), a validated 4-item self-report scale measuring stakeholder perceptions that the content of the PeliCaN doula intervention is satisfactory, scored on a 5-point Likert scale (mean score range 1-5; higher scores indicate greater acceptability). Administered via structured survey to doulas, NICU nurses, and obstetric clinicians at each participating site. Results examined by site, respondent role, and intervention period and will be complimented by semi-structured qualitative interviews with a purposive sample of participants, doulas, and site clinical leaders.
Time frame: End of study, approximately 3 years
Fidelity of PeliCaN Doula Intervention Delivery
Intervention fidelity measured as the average percentage of completed weekly doula contacts among all enrolled intervention participants across the 6-month intervention period. A weekly contact is defined as any documented in-person, phone, or video encounter between the doula and the participant logged in the REDCap Doula Tracking Log. The fidelity metric is calculated per doula and per site as the proportion of expected weekly contacts that were completed, averaged across all enrolled participants and all weeks of the intervention period. Secondary fidelity indicators include the proportion of participants who received EPDS screening at each protocol-specified timepoint and the proportion who received blood pressure monitoring facilitation at designated timepoints.
Time frame: 6 months through end of study, approximately 5 years
Receipt of Mental Health Services When Desired and Recommended
Binary (Yes/No) indicator of whether the participant received mental health services (therapy, psychiatry) when such treatment was either desired by the participant or recommended by their healthcare professional during the study period. Ascertained by self-report on the 6-month follow-up survey. This measure captures whether the doula intervention facilitates follow-through on mental health referrals rather than referral alone.
Time frame: Enrollment through 6 months postpartum
Infant NICU Length of Stay
Continuous measure of the total number of days the infant was hospitalized in the NICU from birth to discharge, transfer, or death. Ascertained by electronic health record abstraction from infant electronic medical record review. Examined as a secondary outcome to assess whether doula-facilitated maternal care coordination influences the clinical trajectory of the NICU hospitalization.
Time frame: From the date of enrollment to the date of infant discharge, transfer, or death from any cause, whichever came first, assessed for up to three years
Maternal Urgent Care, Emergency Department, and Hospitalization Visits
Count and type of maternal urgent care visits, emergency department visits, and unplanned hospitalizations occurring in the postpartum period through 6 months. Ascertained by participant self-report on the 6-month follow-up survey and confirmed by electronic health record abstraction. Outcomes examined include any utilization (Yes/No), total number of visits, and visit type. Postpartum hypertensive emergencies and psychiatric crises will be captured within this measure.
Time frame: Birth through 6 months postpartum
Generalized Anxiety Disorder Symptoms (GAD-7)
Anxiety symptom severity assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7), a validated self-report measure scored 0-21. Scores of 5, 10, and 15 represent mild, moderate, and severe anxiety thresholds, respectively. Administered on the 6-month follow-up surveys. Both continuous total scores and the proportion of participants meeting threshold for moderate-to-severe anxiety (GAD-7 ≥10) will be examined.
Time frame: 6 months postpartum
Receipt of Desired Contraception
Binary (Yes/No) indicator of whether the participant received their preferred method of contraception by 6 months postpartum, among participants who reported desiring contraception. Ascertained by self-report on the 6-month follow-up survey. This measure captures whether the doula intervention supports participants in accessing family planning services as part of comprehensive postpartum care.
Time frame: 6 months postpartum
Follow-Up Visit with Primary Care Provider
Participant-reported status of follow-up with a primary care provider (PCP) in the postpartum period, categorized as: (1) visit already completed, (2) visit planned/scheduled, or (3) no visit planned. Ascertained by self-report on the 6-month follow-up survey. Examined as an indicator of whether the doula intervention supports broader healthcare engagement beyond the obstetric postpartum visit.
Time frame: 6 months postpartum
Late Postpartum Blood Pressure Assessment by 12 Weeks
Binary (Yes/No) indicator of whether the participant had a blood pressure measurement performed by a healthcare provider by 12 weeks (84 days) postpartum. Distinct from the primary outcome BP component, which requires BP checks at 3-10 days and 4-8 weeks; this measure captures any documented late postpartum BP assessment regardless of timing within the 12-week window. Ascertained by electronic health record abstraction and self-report.
Time frame: Birth through 12 weeks postpartum
Perceived Social Support During NICU Hospitalization (MSPSS)
Perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), a validated 12-item self-report measure yielding a continuous total score (range 12-84) and three subscale scores (family, friends, and significant other support) on a 7-point Likert scale. Higher scores indicate greater perceived support. Administered at baseline (reflecting support during the NICU stay) and on the 6-month follow-up survey. Change in MSPSS scores from baseline to 6 months will be examined.
Time frame: Baseline (enrollment) and 6 months postpartum
Plan to share: Yes — De-identified individual participant data underlying results reported in primary publications will be shared. Data will be deposited in the NICHD Data and Specimen Hub (DASH) or an equivalent NIH-approved repository no later than the time of primary publication or within 12 months of the primary completion date, whichever comes first.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning at the time of primary publication; available for a minimum of 5 years thereafter.
Access criteria: Data access will be granted to qualified investigators via a data use agreement (DUA).
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