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OpenTrials
Completed

NCT Number: NCT05510284

Post-partum Care in the NICU

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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Key information

Conditions

Postpartum Period

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time to receipt of postpartum care

    Time frame: birth until 6 weeks post-partum

    To be analyzed using a wilcoxin rank sum test

Secondary outcomes

  1. Comparison of effectiveness of intervention for mothers with public vs private insurance

    Time frame: birth until 6 weeks post-partum

    Time to receipt of postpartum care will be compared between mothers with public vs private insurance

  2. Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older.

    Time frame: 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

  3. Receipt of Postpartum care

    Time frame: birth until 6 weeks post-partum

    Binary (yes/no), fishers exact test

Other outcomes

  1. Health related quality of life measured by the CDC Health-Related Quality of Life (HRQOL)

    Time frame: 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

  2. Depression measured by the Edinburgh Postnatal Depression Scale

    Time frame: 6 months postpartum

    Scored 0 through 30, with 30 indicating a worse outcome

  3. Health care utilization - Number of visits

    Time frame: Time of birth until 6 months postpartum

    PhenXToolkit- 270101 Heathcare utilization and access survery

  4. Breastfeeding- ever

    Time frame: 6 months postpartum

    PhenXToolkit-50101 BreasfeedingOutcomes: ever received breastmilk

  5. Breastfeeding- length of time exclusive breastmilk

    Time frame: 6 months postpartum

    PhenXToolkit-50101 BreasfeedingOutcomes: length of time exclusive breastmilk

  6. Breastfeeding- age at stopping breastmilk

    Time frame: 6 months postpartum

    PhenXToolkit-50101 BreasfeedingOutcomes:age at stopping breastmilk receipt (if relevant))

  7. Diet

    Time frame: 6 months postpartum

    Dietary Screener Questionaire (DSQ) 30-items NHANES (Outcome: Cups of fruits or vegetables per day, [more is better])

  8. Physical activity

    Time frame: 6 months postpartum

    International physical activity questionnaire - short form (Scored as Total physical activity, expressed as minutes per week)

  9. Posttraumatic stress disorder symptoms (PTSD)

    Time frame: 6 months postpartum

    PTSD Checklist for DSM-5 (PCL-5), Scored 0 to 40 with a 40 indicating a worse outcome.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: PeliCaN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2022
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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