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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doula Coordinated-Care Arm | Active Comparator | 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. |
|
| Standard Postpartum Care Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doula-coordinated, midwife-delivered postpartum care | Other | 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life measured by the CDC Health-Related Quality of Life (HRQOL) | A 14 item survey scoring between 0 and 30, in which a higher score represents a worse health related quality of life | 6 months postpartum |
| Depression measured by the Edinburgh Postnatal Depression Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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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 |
Scored 0 through 30, with 30 indicating a worse outcome |
| 6 months postpartum |
| Health care utilization - Number of visits | PhenXToolkit- 270101 Heathcare utilization and access survery | Time of birth until 6 months postpartum |
| Breastfeeding- ever | PhenXToolkit-50101 BreasfeedingOutcomes: ever received breastmilk | 6 months postpartum |
| Breastfeeding- length of time exclusive breastmilk | PhenXToolkit-50101 BreasfeedingOutcomes: length of time exclusive breastmilk | 6 months postpartum |
| Breastfeeding- age at stopping breastmilk | PhenXToolkit-50101 BreasfeedingOutcomes:age at stopping breastmilk receipt (if relevant)) | 6 months postpartum |
| Diet | Dietary Screener Questionaire (DSQ) 30-items NHANES (Outcome: Cups of fruits or vegetables per day, [more is better]) | 6 months postpartum |
| Physical activity | International physical activity questionnaire - short form (Scored as Total physical activity, expressed as minutes per week) | 6 months postpartum |
| Posttraumatic stress disorder symptoms (PTSD) | PTSD Checklist for DSM-5 (PCL-5), Scored 0 to 40 with a 40 indicating a worse outcome. | 6 months postpartum |