Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT06521398

Conditions

Stress Disorders, Post-Traumatic

Premature Birth

Postpartum Depression

Postpartum Anxiety

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Doula Support

Study Details

Brief summary:

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

Conditions

Stress Disorders, Post-Traumatic

Premature Birth

Postpartum Depression

Postpartum Anxiety

Study ID

NCT06521398

Start date

Sep 11, 2024

Status verified date

Oct, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • HUP postpartum patients who are at least 16 years old at the time their newborns' birth
  • Infant born at HUP
  • Preterm birth <34 weeks
  • English language speaking

Exclusion Criteria:

  • Unable to read or sign informed consent
  • Parents of infants transferred into HUP NICU
  • If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks
  • HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Doula Intervention

Participants randomized to the intervention will be offered doula support including care coordination to mental and medical health services in the neonatal intensive care unit (NICU), with a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

no intervention: Control

Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care.

Interventions

Doula Support

Doula support including care coordination to mental and medical health services in the NICU, with a warm handoff to a community doula to continue the support once infants leave the HUP NICU.

Primary outcome measure

  • Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum [ Time Frame: 6 months ]
  • Number of participants who have attendance with a primary care provider by 6 months postpartum [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Heather Burris, MD MPH

(215) 573-4916Burrish@chop.edu

Niesha Darden

dardenn2@chop.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Heather Burris, MD MPH

(215) 573-4916burrish@chop.edu

Niesha Darden

dardenn2@chop.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-10-14.