Post-partum Care in the NICU

Study Overview
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Brief Summary
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This is a pilot randomized control trial to demonstrate the feasibility of a novel model of dyad-centered, doula-coordinated, midwife-delivered postpartum care located in the NICU in a large urban hospital.

Official Title
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Post-partum Care in the NICU

Conditions
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Postpartum Period

Intervention / Treatment
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* Other: Doula-coordinated, midwife-delivered postpartum care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm birth <34 weeks Signed medical record release form Exclusion Criteria: Unable to read or sign informed consent If the medical team believes that the infant may die or be transferred to another hospital in upcoming weeks PI Discretion
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Doula Coordinated-Care Arm<br>Postpartum care will be doula-coordinated. The doula will meet with the mother at least once a week during their infant's NICU stay, with a minimum of 3 meetings. Participants will be given the option of seeing the study nurse midwife or their own provider. If the participant opts to see the nurse midwife, they can meet in a private office located in the NICU. The doula, as typical of the doula role, will coordinate any needed community services in the transition to home. | Other: Doula-coordinated, midwife-delivered postpartum care<br>* A doula will coordinate all postpartum care and provide support to the participant. A midwife will be available on-site in the NICU to provide postpartum care.<br>|
| No Intervention: Standard Postpartum Care Arm<br>In this arm participants will receive usual postpartum care. They will be discharged from the hospital while their baby is still in the NICU and a plan will be made to for follow-up with their provider as an outpatient at some point in the next 6 weeks. The study coordinator will provide the participant with a community postpartum resources list. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to receipt of postpartum care | To be analyzed using a wilcoxin rank sum test | birth until 6 weeks post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of effectiveness of intervention for mothers with public vs private insurance | Time to receipt of postpartum care will be compared between mothers with public vs private insurance | birth until 6 weeks post-partum | 
| Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older. | Time to receipt of postpartum care will be compared between mothers with infants with a gestational age of less than or equal to 28 6/7 weeks vs a gestational age greater than or equal to 29 weeks | birth until 6 weeks post-partum | 
| Receipt of Postpartum care | Binary (yes/no), fishers exact test | birth until 6 weeks post-partum |