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NCT Number: NCT07787845

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.

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.

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Key information

About this study

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 nurse-midwife postpartum care and doula-coordinated postpartum care, mental health screening and referral, and screening and treatment for iron deficiency anemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of receipt of postpartum care within 2 weeks of delivery

    Time frame: From delivery of infant(s) to 2 weeks postpartum

  2. Rate of receipt of postpartum care within 6 weeks of delivery

    Time frame: From delivery of infant(s) to 6 weeks postpartum

Secondary outcomes

  1. Time to receipt of postpartum care visit within 6 weeks postpartum

    Time frame: From delivery of infant(s) to 6 weeks postpartum

  2. Number of outpatient visits within 6 months postpartum

    Time frame: From delivery of infant(s) to 6 months postpartum

  3. Rate of postpartum depression at 6 months postpartum

    Time frame: At 6 months postpartum

    Measured using the Edinburgh Postnatal Depression Scale (EPDS)

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

    Time frame: At 6 months postpartum

    Measured using the PTSD Checklist for DSM-5 (PCL-5)

  5. Rate of milk expression/breastfeeding initiation

    Time frame: At 6 months postpartum

  6. Duration of exclusive breastfeeding

    Time frame: At 6 months postpartum

  7. Rate of treatment for iron deficiency anemia in the intervention group

    Time frame: From delivery of infant(s) up to 6 weeks postpartum

    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.

  8. Rate of emergency department visits within 12 months postpartum

    Time frame: At 1 year postpartum

  9. Rate of postpartum readmissions within 12 months postpartum

    Time frame: At 1 year postpartum

  10. Average daily expressed breastmilk volume in the NICU in the first 7, 14, or 28 days

    Time frame: 7, 14, 28 days

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Prisma Health-Midlands

Registry information

Official study title

Nurturing, Empowering, Supporting Together (NEST): a Project to Improve Postpartum Birth Outcomes in the NICU.

Acronym: NEST

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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