Post-partum Care in the NICU

NCT05510284 | Completed

• 1 other identifier: 851606
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Period

Outcome Measures

Primary Outcomes (1)

• Time to receipt of postpartum care

  To be analyzed using a wilcoxin rank sum test

  birth until 6 weeks post-partum

Secondary Outcomes (3)

• Comparison of effectiveness of intervention for 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.

  birth until 6 weeks post-partum

• Receipt of Postpartum care

  birth until 6 weeks post-partum

Other Outcomes (9)

• Health related quality of life measured by the CDC Health-Related Quality of Life (HRQOL)

  6 months postpartum

• Depression measured by the Edinburgh Postnatal Depression Scale

  6 months postpartum

• Health care utilization - Number of visits

  Time of birth until 6 months postpartum

Study Arms (2)

Doula Coordinated-Care Arm

ACTIVE COMPARATOR

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

Standard Postpartum Care Arm

NO INTERVENTION

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.

Interventions

Doula-coordinated, midwife-delivered postpartum care OTHER

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.

Doula Coordinated-Care Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start: November 29, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)