NCT02372266

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,223

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Apr 1997

Longer than P75 for not_applicable pregnancy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
13.5 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

3.8 years

First QC Date

February 3, 2015

Last Update Submit

February 19, 2015

Conditions

Pregnancy

Keywords

Infant, Newbornhospital dischargeEarly newborn dischargeNewborn length of stayMaternity length of stay

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (21)

  • Emergency department visits, clinic visits, or hospital admissions

    72 hours

  • Emergency department visits, clinic visits, or hospital admissions

    14 days

  • Emergency department visits, clinic visits, or hospital admissions

    8 weeks

  • Emergency department visits, clinic visits, or hospital admissions

    6 months

  • Breastfeeding score (5 point Likert scale)

    At discharge (12 to 72 hours after delivery)

  • +16 more secondary outcomes

Study Arms (2)

Early Discharge Group

EXPERIMENTAL

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

Routine Stay Group

ACTIVE COMPARATOR

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

Other: Routine discharge

Interventions

Early Maternal-Newborn Infant DischargeOTHER

Discharge from the hospital between 12-24 hours of life

Early Discharge Group
Routine dischargeOTHER

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

Routine Stay Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All pregnant women enrolling for obstetric care at a large military academic health center

You may not qualify if:

  • Planning a move from the area before delivery
  • Multiple gestations
  • Pre-existing maternal diabetes
  • Maternal chronic hypertension
  • Maternal age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • William H Barth, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 26, 2015

Study Start

April 1, 1997

Primary Completion

January 1, 2001

Study Completion

August 1, 2001

Last Updated

February 26, 2015

Record last verified: 2015-02