Prisma Health Richland
Columbia, South Carolina, 29203, United States
NCT Number: NCT07787845
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Columbia, South Carolina, 29203, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From delivery of infant(s) to 2 weeks postpartum
Time frame: From delivery of infant(s) to 6 weeks postpartum
Time frame: From delivery of infant(s) to 6 weeks postpartum
Time frame: From delivery of infant(s) to 6 months postpartum
Time frame: At 6 months postpartum
Measured using the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: At 6 months postpartum
Measured using the PTSD Checklist for DSM-5 (PCL-5)
Time frame: At 6 months postpartum
Time frame: At 6 months postpartum
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.
Time frame: At 1 year postpartum
Time frame: At 1 year postpartum
Time frame: 7, 14, 28 days
University of South Carolina
Other
Nurturing, Empowering, Supporting Together (NEST): a Project to Improve Postpartum Birth Outcomes in the NICU.
Acronym: NEST
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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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