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.

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT07787845
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doula-coordinated, Midwife-delivered postpartum care — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control
    Participants will receive routine postpartum care by their regular OB provider office and will fill remotely questionnaires at 6 months regarding mental health and breastfeeding practices.
  • Experimental: Intervention
    Participants will receive at least weekly doula support while their newborn(s)/ infant(s) is/are admitted in the NICU, for a minimum of 3 visits. Participants will have the option to receive routine postpartum care through by their regular OB provider office or by the nurse and nurse-midwife associated with the study on NICU premises. They will remotely fill a mental health questionnaire at 3 months and questionnaires at 6 months regarding breastfeeding practices and satisfaction with the program.

Primary Outcome Measure

Rate of receipt of postpartum care within 2 weeks of delivery [ Time Frame: From delivery of infant(s) to 2 weeks postpartum ]

Locations (1)

FacilityCityStateZIPSite coordinators
Prisma Health RichlandColumbiaSouth Carolina29203
Research Nurse
[email protected]
803-687-9974

Find similar trials in Columbia, SC

By research site
Prisma Health Richland· Columbia, SC

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