Postpartum Care in the NICU Multi-Site

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.

• Postpartum Doula Support in the NICU (Behavioral): 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.

Primary outcomes

• Receipt of Comprehensive Postpartum Care (Composite) [From birth through 12 weeks postpartum]: 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.

Secondary outcomes

• Secondary Effectiveness Outcome - Long-Term Hypertension Management [From birth through six months postpartum]: 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.
• Secondary Effectiveness Outcome - Depression Symptoms Score [From birth through six months postpartum]: 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.
• Feasibility - Feasibility of Intervention Measure (FIM) [Birth to end of study, approximately 3 years]: 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.
• Feasibility - Average Enrollment [From birth to end of study, approximately 3 years]: 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.
• Acceptability of the PeliCaN Doula Intervention (AIM) [End of study, approximately 3 years]: 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.
• Fidelity of PeliCaN Doula Intervention Delivery [6 months through end of study, approximately 5 years]: 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.

Other outcomes

• Receipt of Mental Health Services When Desired and Recommended [Enrollment through 6 months postpartum]: 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.
• Infant NICU Length of Stay [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]: 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.
• Maternal Urgent Care, Emergency Department, and Hospitalization Visits [Birth through 6 months postpartum]: 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.
• Generalized Anxiety Disorder Symptoms (GAD-7) [6 months postpartum]: 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.
• Receipt of Desired Contraception [6 months postpartum]: 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.
• Follow-Up Visit with Primary Care Provider [6 months postpartum]: 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.
• Late Postpartum Blood Pressure Assessment by 12 Weeks [Birth through 12 weeks postpartum]: 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.
• Perceived Social Support During NICU Hospitalization (MSPSS) [Baseline (enrollment) and 6 months postpartum]: 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.

Sex: Female, ages: 18 Years to any

Trial Participant Inclusion Criteria:

* Postpartum individual with an infant currently hospitalized in a participating NICU
* Infant born at less than 34 weeks gestational age, OR infant with a diagnosis associated with a median NICU length of stay of 4 weeks or more (e.g., congenital diaphragmatic hernia, gastroschisis)
* Age 18 years or older at the time of enrollment
* Able to communicate in English or Spanish
* No plans for infant adoption
* No restrictions to visiting their infant(s) in the NICU due to a significant social service issue (e.g., incarceration)
* The clinical team anticipates that their infant, or at least one of their infants if multiples, will remain in the NICU for a minimum of two additional weeks (to avoid anticipated infant palliative care and planned transfers).

Semi-Structured Interview Inclusion Criteria:

* All eligible intervention study participants
* NICU nurses
* Obstetric providers who cared for PeliCaN intervention participants
* English or Spanish as their preferred language

Trial Participant Exclusion Criteria:

* Unable to read or sign informed consent
* If the medical team believes that the infant may die or be transferred to another hospital within 1 week

Semi-Structured Interview Exclusion Criteria:

\- None

• Burris HH, Darden N, Power M, Walker L, Ledyard R, Reiter J, Lewey J, Trout KK, Tan M, Gregory EF, DeMauro SB, Lorch SA, Christ L, Handley SC, Montoya-Williams D, Durnwald C. Postpartum care in the neonatal intensive care unit, PeliCaN: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Jul;7(7):101689. doi: 10.1016/j.ajogmf.2025.101689. Epub 2025 Jun 16. PMID 40334984
• Baumann LJ, Darden N, Ledyard R, Parker MG, Power ME, Walker L, Durnwald CP, Burris HH. Breastfeeding Continuation at 6 Months among Mother-Infant Dyads Participating in the Postpartum Care in the NICU (PeliCaN) Pilot Trial. J Perinatol. 2026 Apr;46(4):646-648. doi: 10.1038/s41372-026-02616-x. Epub 2026 Mar 6. No abstract available. PMID 41792421
• Scott K, Miller E, Culhane JF, Greenspan J, Handley SC, Lo JY, Knake LA, McKenney KM, Nelin TD, Gregory EF, Dysart K, Burris HH. Length of gestation and postpartum visit attendance. Pregnancy (Hoboken). 2026 May;2(3):e70306. doi: 10.1002/pmf2.70306. Epub 2026 May 13. PMID 42282853
• Mari KE, Hoke MK, Darden N, Burris HH. Postpartum care receipt among parents of infants admitted to a freestanding children's hospital neonatal intensive care unit (NICU). J Perinatol. 2026 Mar;46(3):460-466. doi: 10.1038/s41372-025-02476-x. Epub 2025 Nov 17. PMID 41249594
• Scott K, Ledyard RF, Darden N, Durnwald C, Handley SC, Nelin TD, Power M, Sinclair TR, Burris HH. Postpartum care receipt among parents of preterm infants admitted to the neonatal intensive care unit. Am J Obstet Gynecol MFM. 2025 May;7(5):101659. doi: 10.1016/j.ajogmf.2025.101659. Epub 2025 Mar 1. No abstract available. PMID 40032179
• Tan MT, Darden N, Peterson K, Trout KK, Christ L, Handley SC, Kornfield SL, Power ME, Montoya-Williams D, Lewey J, Gregory EF, Lorch SA, DeMauro SB, Levine LD, Burris HH. Bringing postpartum care to the NICU-An opportunity to improve health in a high-risk obstetric population. J Perinatol. 2023 Jan;43(1):1-2. doi: 10.1038/s41372-022-01525-z. Epub 2022 Oct 5. No abstract available. PMID 36198771
• Corson CL, Martin AE, Darden N, Walker L, Power ME, Durnwald CP, Handley SC, Burris HH. Facilitating Postpartum Care with a Doula and Certified Nurse Midwife in the Neonatal Intensive Care Unit: A Qualitative Analysis of Maternal Experiences. Pregnancy (Hoboken). 2025 Nov;1(6):e70179. doi: 10.1002/pmf2.70179. Epub 2025 Nov 14. PMID 41536527

• Heather H Burris, MD, MPH, Principal investigator, Children's Hospital of Philadelphia

NIH grants: R01HD121939