Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

Not Applicable

Completed

• Conditions: Pregnancy

• Registration Number: NCT02372266
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1997-04
• Primary Completion: 2001-01
• Study Completion: 2001-08
• Status Verified: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-19
• Last Update Submitted: 2015-02-19
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2223

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Admission to the Level II/III neonatal care unit or hospital	72 hours	All admissions to the Level II/III neonatal care unit following delivery

Secondary Outcome Measures

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