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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurturing, Empowering, Supporting Together (NEST): a Project to Improve Postpartum Birth Outcomes in the NICU.
- ClinicalTrials.gov ID
- NCT07787845
- Acronym / sponsor ID
- NEST / 2369411
- Keywords
- preterm, doula support, mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Prisma Health-Midlands
- Study start
- 21 Oct 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Doula-delivered, Nurse-coordinated postpartum supportParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula-delivered, Nurse-coordinated postpartum supportDoulas 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. | Behavioural | Intervention |
Primary outcome
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
10 secondary outcomes
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
Time frame: At 6 months postpartum
Rate of post-traumatic stress disorder (PTSD) symptoms at 6 months postpartum
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Doula Support
Not yet recruiting
Postpartum Care in the NICU Multi-Site Breastfeeding
Postpartum Complication, Postpartum
Not yet recruiting
Postpartum Care in the NICU Multi-Site
Postpartum, Postpartum Depression (PPD)
Recruiting
Deconstructing Maternal Burdens: Doulas and the Community Unite for Health
Pregnancy, Post Partum
Active, not recruiting
Well-Mama Community Doula Navigator Study
Pregnancy Related
Recruiting
Understanding the Role of Doulas in Supporting People With PMADs
Maternal Health, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.