Postpartum Period
Conditions
Brief summary
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.
Interventions
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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to receipt of postpartum care | birth until 6 weeks post-partum | To be analyzed using a wilcoxin rank sum test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of effectiveness of intervention for mothers with public vs private insurance | birth until 6 weeks post-partum | Time to receipt of postpartum care will be compared between mothers with public vs private insurance |
| Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older. | birth until 6 weeks post-partum | 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 |
| Receipt of Postpartum care | birth until 6 weeks post-partum | Binary (yes/no), fishers exact test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding- length of time exclusive breastmilk | 6 months postpartum | PhenXToolkit-50101 BreasfeedingOutcomes: length of time exclusive breastmilk |
| Breastfeeding- age at stopping breastmilk | 6 months postpartum | PhenXToolkit-50101 BreasfeedingOutcomes:age at stopping breastmilk receipt (if relevant)) |
| Health related quality of life measured by the CDC Health-Related Quality of Life (HRQOL) | 6 months postpartum | A 14 item survey scoring between 0 and 30, in which a higher score represents a worse health related quality of life |
| Physical activity | 6 months postpartum | International physical activity questionnaire - short form (Scored as Total physical activity, expressed as minutes per week) |
| Posttraumatic stress disorder symptoms (PTSD) | 6 months postpartum | PTSD Checklist for DSM-5 (PCL-5), Scored 0 to 40 with a 40 indicating a worse outcome. |
| Diet | 6 months postpartum | Dietary Screener Questionaire (DSQ) 30-items NHANES (Outcome: Cups of fruits or vegetables per day, \[more is better\]) |
| Depression measured by the Edinburgh Postnatal Depression Scale | 6 months postpartum | Scored 0 through 30, with 30 indicating a worse outcome |
| Health care utilization - Number of visits | Time of birth until 6 months postpartum | PhenXToolkit- 270101 Heathcare utilization and access survery |
| Breastfeeding- ever | 6 months postpartum | PhenXToolkit-50101 BreasfeedingOutcomes: ever received breastmilk |
Countries
United States
Outcome results
None listed