An interventional study of Doula-delivered, Nurse-coordinated postpartum support in Doula Support, Postpartum and Postpartum Depression (PPD), sponsored by University of South Carolina. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of South Carolina · Not applicable, Interventional, and Prevention
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.
This study will employ a randomized controlled trial design. Participants will be recruited from Prisma Health Richland Hospital and may be enrolled during late pregnancy (including individuals on bed rest), in a postpartum unit, or while their infant is admitted to the NICU. Inclusion criteria will be English speaking individuals ≥18 years old on Medicaid insurance, who delivered a baby \<34 weeks' gestation, and whose baby will be admitted to the NICU. The control arm of the trial will receive standard postpartum care, while the intervention arm will receive doula postpartum support and nurse-coordinated postpartum care, mental health screening and referral, and consistent follow-up for iron deficiency anemia.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 350 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Behavioral: 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.
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
Time to receipt of postpartum care visit within 6 weeks postpartum
Time frame: From delivery of infant(s) to 6 weeks postpartum
Number of outpatient visits within 6 months postpartum
Time frame: From delivery of infant(s) to 6 months postpartum
Rate of postpartum depression at 6 months postpartum
Measured using the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: At 6 months postpartum
Rate of post-traumatic stress disorder (PTSD) symptoms at 6 months postpartum
Measured using the PTSD Checklist for DSM-5 (PCL-5)
Time frame: At 6 months postpartum
Rate of milk expression/breastfeeding initiation
Time frame: At 6 months postpartum
Duration of exclusive breastfeeding
Time frame: At 6 months postpartum
Rate of treatment for iron deficiency anemia in the intervention group
Participants whose last hemoglobin (Hb) measurement during the delivery hospitalization was \<10 g/dL will undergo repeat Hb assessment at approximately 2 weeks postpartum. Participants with a postpartum Hb \<9 g/dL will undergo iron studies to evaluate for iron deficiency. Management of iron deficiency anemia, including oral or intravenous iron therapy as clinically indicated, will be provided in accordance with current clinical guidelines and the treating clinician's judgment.
Time frame: From delivery of infant(s) up to 6 weeks postpartum
Rate of emergency department visits within 12 months postpartum
Time frame: At 1 year postpartum
Rate of postpartum readmissions within 12 months postpartum
Time frame: At 1 year postpartum
Average daily expressed breastmilk volume in the NICU in the first 7, 14, or 28 days
Time frame: 7, 14, 28 days
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Aug 2029, 34 months after the start.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 34 months is above that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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