Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

59th Medical Wing

Status: Completed

Conditions: Pregnancy

Treatments: Other: Early Maternal-Newborn Infant Discharge; Other: Routine discharge

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02372266

SGO 96-042

DI950076 (Other Grant/Funding Number)

FWH19960042H (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,223 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,223 participants in 2 patient groups

Early Discharge Group

Experimental group

Description:

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.

Treatment:

Other: Early Maternal-Newborn Infant Discharge

Routine Stay Group

Active Comparator group

Description:

Women and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours.

Treatment:

Other: Routine discharge