Doula SupportNESTNCT07787845
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
A study testing Doula-delivered, Nurse-coordinated postpartum support in people with Doula Support and Postpartum, run by University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Doula Support, Postpartum, Postpartum Depression (PPD)
- What is being tested?
- Doula-delivered, Nurse-coordinated postpartum support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2026to Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prisma Health Richland
Columbia, South Carolina, 29203
Research Nurse, 803-687-9974, gwendoline.helin-milgrom@prismahealth.org
About this study
Official title: Nurturing, Empowering, Supporting Together (NEST): a Project to Improve Postpartum Birth Outcomes in the NICU.
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.
Read the detailed description
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.
- Being tested
- Doula-delivered, Nurse-coordinated postpartum support
- Keywords
- preterm, doula support, mental health
- Medical subject headings
- Depression, Postpartum, Premature Birth, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula-delivered, Nurse-coordinated postpartum supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 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. Receives: Behavioral: Doula-delivered, Nurse-coordinated postpartum support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of receipt of postpartum care within 2 weeks of delivery
Measured: From delivery of infant(s) to 2 weeks postpartum
Rate of receipt of postpartum care within 6 weeks of delivery
Measured: From delivery of infant(s) to 6 weeks postpartum
Secondary outcomes (10)
Time to receipt of postpartum care visit within 6 weeks postpartum
Measured: From delivery of infant(s) to 6 weeks postpartum
Number of outpatient visits within 6 months postpartum
Measured: 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)
Measured: 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)
Measured: At 6 months postpartum
Rate of milk expression/breastfeeding initiation
Measured: At 6 months postpartum
Duration of exclusive breastfeeding
Measured: 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.
Measured: From delivery of infant(s) up to 6 weeks postpartum
Rate of emergency department visits within 12 months postpartum
Measured: At 1 year postpartum
Rate of postpartum readmissions within 12 months postpartum
Measured: At 1 year postpartum
Average daily expressed breastmilk volume in the NICU in the first 7, 14, or 28 days
Measured: 7, 14, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start21 Oct 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doula SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Health-Midlands
- Responsible party
- Principal investigator, Nansi Boghossian, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787845
- Sponsor's protocol ID
- 2369411
- Acronym
- NEST
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No