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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Early Maternal-Newborn Infant Discharge; Other: Routine discharge

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.

• Study Type: Interventional
• Enrollment (Actual): 2223
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admission to the Level II/III neonatal care unit or hospital	All admissions to the Level II/III neonatal care unit following delivery	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	72 hours
Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	14 days
Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	8 weeks
Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	6 months
Breastfeeding score (5 point Likert scale)	5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle	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	14 days
Breastfeeding score (5 point Likert scale)	5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle	8 weeks
Breastfeeding score (5 point Likert scale)	5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle	6 months
Maternal anxiety (State/Trait Anxiety Inventory)		At discharge (12 to 72 hours after delivery)
Maternal anxiety (State/Trait Anxiety Inventory)	State/Trait Anxiety Inventory	14 days
Maternal depression (Generalized Contentment Scale)	Generalized Contentment Scale	At discharge (12 to 72 hours after delivery)
Maternal depression (Generalized Contentment Scale)	Generalized Contentment Scale	14 days
Maternal confidence (Confidence on a Likert scale)	Confidence on a Likert scale	At discharge (12 to 72 hours after delivery)
Maternal confidence (Confidence on a Likert scale)	Confidence on a Likert scale	14 days
Maternal satisfaction with length of stay (Likert scale)	Satisfaction with length of stay on a Likert scale	At discharge (12 to 72 hours after delivery)
Maternal satisfaction with length of stay (Likert scale)	Satisfaction with length of stay on a Likert scale	14 days
Maternal satisfaction with overall experience (Likert scale)	Satisfaction with overall childbirth experience on a Likert scale	At discharge (12 to 72 hours after delivery)
Maternal satisfaction with overall experience (Likert scale)	Satisfaction with overall childbirth experience on a Likert scale	14 days
Admission to the Level II/III neonatal care unit or hospital	All admissions to the Level II/III neonatal care unit following delivery	14 days
Admission to the Level II/III neonatal care unit or hospital	All admissions to the Level II/III neonatal care unit following delivery	8 weeks
Admission to the Level II/III neonatal care unit or hospital	All admissions to the Level II/III neonatal care unit following delivery	6 months

Collaborators and Investigators

• Sponsor: 59th Medical Wing
• Investigators: Principal Investigator: William H Barth, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 1997
• Primary Completion (Actual): January 1, 2001
• Study Completion (Actual): August 1, 2001

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Infant, Newborn; hospital discharge; Early newborn discharge; Newborn length of stay; Maternity length of stay
• 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)