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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.

ConditionsDoula SupportPostpartumPostpartum AnaemiaPostpartum Depression (PPD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

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

Measured using the Edinburgh Postnatal Depression Scale (EPDS)

Time frame
At 6 months postpartum
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Carolina

Lead sponsor

Prisma Health-Midlands

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: