MedPath

Post-partum Care in the NICU

Not Applicable
Completed
Conditions
Postpartum Period
Interventions
Other: Doula-coordinated, midwife-delivered postpartum care
Registration Number
NCT05510284
Lead Sponsor
University of Pennsylvania
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
37
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Doula Coordinated-Care ArmDoula-coordinated, midwife-delivered postpartum carePostpartum 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.
Primary Outcome Measures
NameTimeMethod
Time to receipt of postpartum carebirth until 6 weeks post-partum

To be analyzed using a wilcoxin rank sum test

Secondary Outcome Measures
NameTimeMethod
Receipt of Postpartum carebirth until 6 weeks post-partum

Binary (yes/no), fishers exact test

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

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

Comparison of effectiveness of intervention for mothers with public vs private insurancebirth until 6 weeks post-partum

Time to receipt of postpartum care will be compared between mothers with public vs private insurance

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

© Copyright 2025. All Rights Reserved by MedPath