Post-partum Care in the NICU (PeliCaN)

This is a pilot randomized control trial to demonstrate the feasibility of a novel model of dyad-centered, doula-coordinated, midwife-delivered postpartum care located in the NICU in a large urban hospital.

Study Overview

• Status: Completed
• Conditions: Postpartum Period
• Intervention / Treatment: Other: Doula-coordinated, midwife-delivered postpartum care

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preterm birth <34 weeks
• Signed medical record release form

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 in upcoming weeks
• PI Discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Doula Coordinated-Care Arm; Postpartum care will be doula-coordinated. The doula will meet with the mother at least once a week during their infant's NICU stay, with a minimum of 3 meetings. Participants will be given the option of seeing the study nurse midwife or their own provider. If the participant opts to see the nurse midwife, they can meet in a private office located in the NICU. The doula, as typical of the doula role, will coordinate any needed community services in the transition to home.	Other: Doula-coordinated, midwife-delivered postpartum care; A doula will coordinate all postpartum care and provide support to the participant. A midwife will be available on-site in the NICU to provide postpartum care.
No Intervention: Standard Postpartum Care Arm; In this arm participants will receive usual postpartum care. They will be discharged from the hospital while their baby is still in the NICU and a plan will be made to for follow-up with their provider as an outpatient at some point in the next 6 weeks. The study coordinator will provide the participant with a community postpartum resources list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to receipt of postpartum care	To be analyzed using a wilcoxin rank sum test	birth until 6 weeks post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of effectiveness of intervention for mothers with public vs private insurance	Time to receipt of postpartum care will be compared between mothers with public vs private insurance	birth until 6 weeks post-partum
Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older.	Time to receipt of postpartum care will be compared between mothers with infants with a gestational age of less than or equal to 28 6/7 weeks vs a gestational age greater than or equal to 29 weeks	birth until 6 weeks post-partum
Receipt of Postpartum care	Binary (yes/no), fishers exact test	birth until 6 weeks post-partum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life measured by the CDC Health-Related Quality of Life (HRQOL)	A 14 item survey scoring between 0 and 30, in which a higher score represents a worse health related quality of life	6 months postpartum
Depression measured by the Edinburgh Postnatal Depression Scale	Scored 0 through 30, with 30 indicating a worse outcome	6 months postpartum
Health care utilization - Number of visits	PhenXToolkit- 270101 Heathcare utilization and access survery	Time of birth until 6 months postpartum
Breastfeeding- ever	PhenXToolkit-50101 BreasfeedingOutcomes: ever received breastmilk	6 months postpartum
Breastfeeding- length of time exclusive breastmilk	PhenXToolkit-50101 BreasfeedingOutcomes: length of time exclusive breastmilk	6 months postpartum
Breastfeeding- age at stopping breastmilk	PhenXToolkit-50101 BreasfeedingOutcomes:age at stopping breastmilk receipt (if relevant))	6 months postpartum
Diet	Dietary Screener Questionaire (DSQ) 30-items NHANES (Outcome: Cups of fruits or vegetables per day, [more is better])	6 months postpartum
Physical activity	International physical activity questionnaire - short form (Scored as Total physical activity, expressed as minutes per week)	6 months postpartum
Posttraumatic stress disorder symptoms (PTSD)	PTSD Checklist for DSM-5 (PCL-5), Scored 0 to 40 with a 40 indicating a worse outcome.	6 months postpartum

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 851606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No