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Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

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ClinicalTrials.gov Identifier: NCT02372266
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
William H. Barth, Jr., M.D., Col(ret), USAF, MC, 59th Medical Wing

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Early Maternal-Newborn Infant Discharge Other: Routine discharge Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
Study Start Date : April 1997
Actual Primary Completion Date : January 2001
Actual Study Completion Date : August 2001

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Discharge Group
If safety criteria were met, women and infants were discharged home from the hospital at 12 to 24 hours after delivery with a planned home health visit within 48 hours of the discharge.
Other: Early Maternal-Newborn Infant Discharge
Discharge from the hospital between 12-24 hours of life

Active Comparator: Routine Stay Group
Women and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours.
Other: Routine discharge
Discharge of the mother and newborn 2 to 3 days after delivery




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372266


Sponsors and Collaborators
59th Medical Wing
Investigators
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Principal Investigator: William H Barth, MD Massachusetts General Hospital
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Responsible Party: William H. Barth, Jr., M.D., Col(ret), USAF, MC, Chairman, Department of Obstetrics and Gynecology, 59th Medical Wing
ClinicalTrials.gov Identifier: NCT02372266    
Other Study ID Numbers: SGO 96-042
DI950076 ( Other Grant/Funding Number: Department of Defense Women's Health Intramural Research )
FWH19960042H ( Other Identifier: Wilford Hall Medical Center )
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Keywords provided by William H. Barth, Jr., M.D., Col(ret), USAF, MC, 59th Medical Wing:
Infant, Newborn
hospital discharge
Early newborn discharge
Newborn length of stay
Maternity length of stay