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Completed

NCT Number: NCT02372266

Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

To determine the effect of a policy of early maternal-newborn infant discharge (12-24 hours) with a home visit on admission to the Level II/III nursery and hospital admissions and readmissions.

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Key information

Conditions

Pregnancy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This is a randomized controlled trial designed to assess the safety of a policy of early maternal newborn infant discharge compared to a policy of routine discharge 2 to 3 days after delivery. The primary outcome is newborn admissions to the Level II or Level III neonatal care unit or hospital within three days of delivery. Secondary outcomes included admissions and readmissions at 2 weeks, 6 weeks and 6 months following delivery, maternal satisfaction with length of stay and overall birthing experience, lactation continuation rates, maternal anxiety, depression, confidence and family functioning. We applied the American Academy of Pediatrics criteria for early newborn discharge, but planned the analysis by intention to treat.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All pregnant women enrolling for obstetric care at a large military academic health center

Exclusion criteria

  • Planning a move from the area before delivery
  • Multiple gestations
  • Pre-existing maternal diabetes
  • Maternal chronic hypertension
  • Maternal age < 18

Treatment and study plan

Early Maternal-Newborn Infant Discharge

Other

Discharge from the hospital between 12-24 hours of life

Routine discharge

Other

Discharge of the mother and newborn 2 to 3 days after delivery

Primary outcomes

  1. Admission to the Level II/III neonatal care unit or hospital

    Time frame: 72 hours

    All admissions to the Level II/III neonatal care unit following delivery

Secondary outcomes

  1. Emergency department visits, clinic visits, or hospital admissions

    Time frame: 72 hours

    Any unplanned pediatric visit to an emergency room, clinic or a hospital admission

  2. Emergency department visits, clinic visits, or hospital admissions

    Time frame: 14 days

    Any unplanned pediatric visit to an emergency room, clinic or a hospital admission

  3. Emergency department visits, clinic visits, or hospital admissions

    Time frame: 8 weeks

    Any unplanned pediatric visit to an emergency room, clinic or a hospital admission

  4. Emergency department visits, clinic visits, or hospital admissions

    Time frame: 6 months

    Any unplanned pediatric visit to an emergency room, clinic or a hospital admission

  5. Breastfeeding score (5 point Likert scale)

    Time frame: At discharge (12 to 72 hours after delivery)

    5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle

  6. Breastfeeding score (5 point Likert scale)

    Time frame: 14 days

    5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle

  7. Breastfeeding score (5 point Likert scale)

    Time frame: 8 weeks

    5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle

  8. Breastfeeding score (5 point Likert scale)

    Time frame: 6 months

    5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle

  9. Maternal anxiety (State/Trait Anxiety Inventory)

    Time frame: At discharge (12 to 72 hours after delivery)

  10. Maternal anxiety (State/Trait Anxiety Inventory)

    Time frame: 14 days

    State/Trait Anxiety Inventory

  11. Maternal depression (Generalized Contentment Scale)

    Time frame: At discharge (12 to 72 hours after delivery)

    Generalized Contentment Scale

  12. Maternal depression (Generalized Contentment Scale)

    Time frame: 14 days

    Generalized Contentment Scale

  13. Maternal confidence (Confidence on a Likert scale)

    Time frame: At discharge (12 to 72 hours after delivery)

    Confidence on a Likert scale

  14. Maternal confidence (Confidence on a Likert scale)

    Time frame: 14 days

    Confidence on a Likert scale

  15. Maternal satisfaction with length of stay (Likert scale)

    Time frame: At discharge (12 to 72 hours after delivery)

    Satisfaction with length of stay on a Likert scale

  16. Maternal satisfaction with length of stay (Likert scale)

    Time frame: 14 days

    Satisfaction with length of stay on a Likert scale

  17. Maternal satisfaction with overall experience (Likert scale)

    Time frame: At discharge (12 to 72 hours after delivery)

    Satisfaction with overall childbirth experience on a Likert scale

  18. Maternal satisfaction with overall experience (Likert scale)

    Time frame: 14 days

    Satisfaction with overall childbirth experience on a Likert scale

  19. Admission to the Level II/III neonatal care unit or hospital

    Time frame: 14 days

    All admissions to the Level II/III neonatal care unit following delivery

  20. Admission to the Level II/III neonatal care unit or hospital

    Time frame: 8 weeks

    All admissions to the Level II/III neonatal care unit following delivery

  21. Admission to the Level II/III neonatal care unit or hospital

    Time frame: 6 months

    All admissions to the Level II/III neonatal care unit following delivery

Sponsors and collaborators

Lead sponsor

59th Medical Wing

Fed

Registry information

Official study title

A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

Important dates

Study start
1997
Primary completion
2001
Study completion
2001
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

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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