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 | Not Yet Recruiting

• 1 other identifier: 2369411
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

preterm; doula support; mental health

Outcome Measures

Primary Outcomes (2)

• Rate of receipt of postpartum care within 2 weeks of delivery

  From delivery of infant(s) to 2 weeks postpartum

• Rate of receipt of postpartum care within 6 weeks of delivery

  From delivery of infant(s) to 6 weeks postpartum

Secondary Outcomes (10)

• Time to receipt of postpartum care visit within 6 weeks postpartum

  From delivery of infant(s) to 6 weeks postpartum

• Number of outpatient visits within 6 months postpartum

  From delivery of infant(s) to 6 months postpartum

• Rate of postpartum depression at 6 months postpartum

  At 6 months postpartum

• Rate of post-traumatic stress disorder (PTSD) symptoms at 6 months postpartum

  At 6 months postpartum

• Rate of milk expression/breastfeeding initiation

  At 6 months postpartum

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Behavioral: Doula-coordinated, Midwife-delivered postpartum care

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Midlands: collaborator

Study Sites (1)

Prisma Health Richland

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Premature Birth; Psychological Well-Being

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)