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Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02372266
Enrollment
2223
Registered
2015-02-26
Start date
1997-04-30
Completion date
2001-08-31
Last updated
2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Infant, Newborn, hospital discharge, Early newborn discharge, Newborn length of stay, Maternity length of stay

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.

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.

Interventions

OTHEREarly Maternal-Newborn Infant Discharge

Discharge from the hospital between 12-24 hours of life

OTHERRoutine discharge

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

Sponsors

59th Medical Wing
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Admission to the Level II/III neonatal care unit or hospital72 hoursAll admissions to the Level II/III neonatal care unit following delivery

Secondary

MeasureTime frameDescription
Breastfeeding score (5 point Likert scale)At discharge (12 to 72 hours after delivery)5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
Maternal anxiety (State/Trait Anxiety Inventory)At discharge (12 to 72 hours after delivery)
Maternal depression (Generalized Contentment Scale)At discharge (12 to 72 hours after delivery)Generalized Contentment Scale
Emergency department visits, clinic visits, or hospital admissions72 hoursAny unplanned pediatric visit to an emergency room, clinic or a hospital admission
Maternal satisfaction with length of stay (Likert scale)At discharge (12 to 72 hours after delivery)Satisfaction with length of stay on a Likert scale
Maternal satisfaction with overall experience (Likert scale)At discharge (12 to 72 hours after delivery)Satisfaction with overall childbirth experience on a Likert scale
Admission to the Level II/III neonatal care unit or hospital14 daysAll admissions to the Level II/III neonatal care unit following delivery
Maternal confidence (Confidence on a Likert scale)At discharge (12 to 72 hours after delivery)Confidence on a Likert scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026