Post-partum Care in the NICU

Postpartum Period Clinical Trial

— PeliCaN  

Official title:

Post-partum Care in the NICU

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05510284
• Other study ID #: 851606
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Postpartum Period

Intervention

Other:
• Doula-coordinated, midwife-delivered postpartum care
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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Depression measured by the Edinburgh Postnatal Depression Scale	Scored 0 through 30, with 30 indicating a worse outcome	6 months postpartum
Other	Health care utilization - Number of visits	PhenXToolkit- 270101 Heathcare utilization and access survery	Time of birth until 6 months postpartum
Other	Breastfeeding- ever	PhenXToolkit-50101 BreasfeedingOutcomes: ever received breastmilk	6 months postpartum
Other	Breastfeeding- length of time exclusive breastmilk	PhenXToolkit-50101 BreasfeedingOutcomes: length of time exclusive breastmilk	6 months postpartum
Other	Breastfeeding- age at stopping breastmilk	PhenXToolkit-50101 BreasfeedingOutcomes:age at stopping breastmilk receipt (if relevant))	6 months postpartum
Other	Diet	Dietary Screener Questionaire (DSQ) 30-items NHANES (Outcome: Cups of fruits or vegetables per day, [more is better])	6 months postpartum
Other	Physical activity	International physical activity questionnaire - short form (Scored as Total physical activity, expressed as minutes per week)	6 months postpartum
Other	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
Primary	Time to receipt of postpartum care	To be analyzed using a wilcoxin rank sum test	birth until 6 weeks post-partum
Secondary	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
Secondary	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
Secondary	Receipt of Postpartum care	Binary (yes/no), fishers exact test	birth until 6 weeks post-partum