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The Goal is to Examine the Impact of Doula-coordinated, Midwife-delivered Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.

NCT07787845 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-08-26

No results posted yet for this study

Summary

The primary objective of this research is to conduct a randomized clinical trial to examine the impact of doula-coordinated, midwife-delivered postpartum care (intervention arm) on postpartum health care utilization, health outcomes, and patient-reported experiences compared with standard postpartum care (control arm) among individuals with preterm births \<34 weeks' gestation requiring neonatal intensive care unit (NICU) admission.

Conditions

  • Doula Support
  • Postpartum
  • Postpartum Anaemia
  • Postpartum Depression (PPD)

Interventions

BEHAVIORAL

Doula-coordinated, Midwife-delivered postpartum care

Doulas offer continuous emotional and physical support, which can help reduce stress and improve mental health outcomes. Nurse-midwives bring specialized knowledge in maternal and newborn care, ensuring that medical and psychosocial needs are addressed holistically. Together, doulas and midwives can enhance the quality of postpartum care, promote maternal well-being, and potentially reduce the incidence of SMM and mortality. This integrated approach can also facilitate better coordination of care and support for birthing individuals.

Sponsors & Collaborators

  • Prisma Health-Midlands

    collaborator OTHER

  • University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-08-31
Completion
2030-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787845 on ClinicalTrials.gov