Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

59th Medical Wing2,223 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,223

Conditions

Pregnancy

Interventions

Early Maternal-Newborn Infant DischargeOTHER

Discharge from the hospital between 12-24 hours of life

Routine dischargeOTHER

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Time frame: 72 hours

Secondary Outcomes

Emergency department visits, clinic visits, or hospital admissions

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

Time frame: 72 hours

Emergency department visits, clinic visits, or hospital admissions

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

Time frame: 14 days

Emergency department visits, clinic visits, or hospital admissions

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

Time frame: 8 weeks

Emergency department visits, clinic visits, or hospital admissions

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

Time frame: 6 months

Breastfeeding score (5 point Likert scale)

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

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

Breastfeeding score (5 point Likert scale)

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

Time frame: 14 days

Breastfeeding score (5 point Likert scale)

Data from ClinicalTrials.gov

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