Recruiting

Nurse-Coordinated Support

Sponsor:

University of South Carolina

Code:

NCT07787845

Conditions

Doula Support

Postpartum

Postpartum Depression (PPD)

Postpartum Anemia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doula-delivered, Nurse-coordinated postpartum support

Study Details

Brief summary:

The primary objective of this research is to conduct a randomized clinical trial to examine the impact of nurse-coordinated, doula-delivered postpartum support (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 Depression (PPD)

Postpartum Anemia

Study ID

NCT07787845

Start date

Oct 21, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age above 18 at time of delivery of infant
  • English-speaking
  • Medicaid insurance coverage at the time of delivery, either as primary or secondary coverage
  • Delivery before 34 weeks' gestation
  • Infant admitted to the NICU, 10 days old or less

Exclusion Criteria:

  • Stillbirth
  • Infant death in the delivery room
  • Infant with severe congenital anomalies expected to result in death shortly after birth
  • Inability to provide informed consent
  • Inability to visit the infant in the NICU at least once per week
  • More than 10 days postpartum

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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 their regular OB provider office or by the nurse associated with the study on NICU premises before going back to their regular OB provider. They will remotely fill a mental health questionnaire at 3 months and questionnaires at 6 months regarding mental health, breastfeeding practices, and satisfaction with the program.

Interventions

Doula-delivered, Nurse-coordinated postpartum support

Doulas offer continuous emotional and physical support, which can help reduce stress and improve mental health outcomes. Nurses bring specialized knowledge in maternal and newborn care, ensuring that medical and psychosocial needs are addressed holistically. Together, doulas and nurses 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.

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 ]
  • Rate of receipt of postpartum care within 6 weeks of delivery [ Time Frame: From delivery of infant(s) to 6 weeks postpartum ]

Central Contacts and Locations

Locations

Prisma Health Richland

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Research Nurse

803-687-9974gwendoline.helin-milgrom@prismahealth.org

More Information

Sponsor

University of South Carolina

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • preterm
  • doula support
  • mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.