Doula Support, Postpartum, Postpartum Anaemia, Postpartum Depression (PPD)
Conditions
Keywords
preterm, doula support, mental health
Brief summary
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.
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 nurse-midwife postpartum care and doula-coordinated postpartum care, mental health screening and referral, and screening and treatment for iron deficiency anemia.
Interventions
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.
Sponsors
Prisma Health-Midlands
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of receipt of postpartum care within 2 weeks of delivery | From delivery of infant(s) to 2 weeks postpartum |
| Rate of receipt of postpartum care within 6 weeks of delivery | From delivery of infant(s) to 6 weeks postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to receipt of postpartum care visit within 6 weeks postpartum | From delivery of infant(s) to 6 weeks postpartum | — |
| Number of outpatient visits within 6 months postpartum | From delivery of infant(s) to 6 months postpartum | — |
| Rate of postpartum depression at 6 months postpartum | At 6 months postpartum | Measured using the Edinburgh Postnatal Depression Scale (EPDS) |
| Rate of post-traumatic stress disorder (PTSD) symptoms at 6 months postpartum | At 6 months postpartum | Measured using the PTSD Checklist for DSM-5 (PCL-5) |
| Rate of milk expression/breastfeeding initiation | At 6 months postpartum | — |
| Duration of exclusive breastfeeding | At 6 months postpartum | — |
| Rate of treatment for iron deficiency anemia in the intervention group | 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. |
| Rate of emergency department visits within 12 months postpartum | At 1 year postpartum | — |
| Rate of postpartum readmissions within 12 months postpartum | At 1 year postpartum | — |
| Average daily expressed breastmilk volume in the NICU in the first 7, 14, or 28 days | 7, 14, 28 days | — |
Countries
United States
Outcome results
None listed