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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
350
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.
Prisma Health Richland
Columbia, South Carolina, United States
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
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