Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2223 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-30

Study Completion Date

2001-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Early Maternal-Newborn Infant Discharge

Intervention Type OTHER

Discharge from the hospital between 12-24 hours of life

Routine Stay Group

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

Group Type ACTIVE_COMPARATOR

Routine discharge

Intervention Type OTHER

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

Interventions

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Early Maternal-Newborn Infant Discharge

Discharge from the hospital between 12-24 hours of life

Intervention Type OTHER

Routine discharge

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

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes