NCT06520566 Holistic Care Partner Program Feasibility and Acceptability
| NCT ID | NCT06520566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Maternal Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2026-08-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 55 participants in total. It began in 2024-07-15 with a primary completion date of 2026-08-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal nurses, Black women/birthing people, and their care partners enrolled in the Holistic Care Partner Program (HCP) to understand the program's feasibility and acceptability. HCP was developed at NYU Langone Health by Blank women-led perinatal nurses to address the effects of obstetric racism and the associated fear of pregnancy and birth faced by Black women and birthing people. Utilizing a mixed-methods approach, the study will focus on understanding HCP's acceptability and feasibility via surveys and qualitative interviews with Black women and birthing people and their partners/support persons to identify strategies and recommendations for intervention improvement. Exploratory analysis of maternal and infant outcomes will be conducted using a propensity score matched historical control group.
Eligibility Criteria
Inclusion Criteria: 1. Identify as Black or within the Black/African Diaspora 2. Enrolled in the HCP program while pregnant or within 6 weeks postpartum 3. Enrolled in the Faculty Group Practice at NYU Langone Health (NYULH) for obstetric care 4. Plan to give birth at NYULH Tisch or gave birth at NYULH Tisch if postpartum at screening. 5. Comfortable reading and/or speaking English (approximately 95% of Black women speak English) 6. Are 18 years or older Exclusion Criteria: 1. Does not identify as Black or within the Black/African Diaspora 2. Did not enroll in the HCP program while pregnant or within 6 weeks postpartum. 3. Not enrolled in the FGP NYULH for obstetric care 4. Does not plan to give birth at NYULH Tisch or did not give birth at NYULH Tisch if postpartum at time of screening. 5. Is not 18 years or older 6. Multiple gestation 7. Significant fetal anomaly requiring exceptional care
Contact & Investigator
Audrey Lyndon, PhD, RNC, FAAN
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06520566 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Maternal Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06520566 currently recruiting?
Yes, NCT06520566 is actively recruiting participants. Contact the research team at al6148@nyu.edu for enrollment information.
Where is the NCT06520566 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06520566 clinical trial?
NCT06520566 is sponsored by NYU Langone Health. The principal investigator is Audrey Lyndon, PhD, RNC, FAAN at NYU Langone Health. The trial plans to enroll 55 participants.