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NESTNCT07787845

The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 7 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Interventions modified
    • Start date changed from estimate of Sep 2026 to Oct 21, 2026
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site details revised
    • Study title revised
    • Study description shortened, about 1 word
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Rate of receipt of postpartum care within 2 weeks of delivery
Timeframe: From delivery of infant(s) to 2 weeks postpartum
Rate of receipt of postpartum care within 6 weeks of delivery
Timeframe: From delivery of infant(s) to 6 weeks postpartum

Secondary (10)

Time to receipt of postpartum care visit within 6 weeks postpartum
Number of outpatient visits within 6 months postpartum
Rate of postpartum depression at 6 months postpartum
Rate of post-traumatic stress disorder (PTSD) symptoms at 6 months postpartum
Rate of milk expression/breastfeeding initiation
Show 5 moreShow less
Duration of exclusive breastfeeding
Rate of treatment for iron deficiency anemia in the intervention group
Rate of emergency department visits within 12 months postpartum
Rate of postpartum readmissions within 12 months postpartum
Average daily expressed breastmilk volume in the NICU in the first 7, 14, or 28 days

Arms and interventions

ControlNo intervention

Participants will receive routine postpartum care by their regular OB provider office and will fill remotely questionnaires at 6 months regarding mental health and breastfeeding practices.

InterventionExperimental

Participants will receive at least weekly doula support while their newborn(s)/ infant(s) is/are admitted in the NICU, for a minimum of 3 visits. Participants will have the option to receive routine postpartum care through their regular OB provider office or by the nurse associated with the study on NICU premises before going back to their regular OB provider. They will remotely fill a mental health questionnaire at 3 months and questionnaires at 6 months regarding mental health, breastfeeding practices, and satisfaction with the program.

Behavioral: Doula-delivered, Nurse-coordinated postpartum support

Sites

1 site in 1 country

  • Prisma Health RichlandColumbia, South Carolina, United States