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Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

19. februar 2015 opdateret af: William H. Barth, Jr., M.D., Col(ret), USAF, MC, 59th Medical Wing

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2223

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Early Maternal-Newborn Infant Discharge
Discharge from the hospital between 12-24 hours of life
Aktiv komparator: Routine Stay Group
Women and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours.
Andet: Routine discharge
Discharge of the mother and newborn 2 to 3 days after delivery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Admission to the Level II/III neonatal care unit or hospital
Tidsramme: 72 hours
All admissions to the Level II/III neonatal care unit following delivery
72 hours

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

59th Medical Wing

Efterforskere

  • Ledende efterforsker: William H Barth, MD, Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 1997

Primær færdiggørelse (Faktiske)

1. januar 2001

Studieafslutning (Faktiske)

1. august 2001

Datoer for studieregistrering

Først indsendt

3. februar 2015

Først indsendt, der opfyldte QC-kriterier

19. februar 2015

Først opslået (Skøn)

26. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • SGO 96-042
  • DI950076 (Andet bevillings-/finansieringsnummer: Department of Defense Women's Health Intramural Research)
  • FWH19960042H (Anden identifikator: Wilford Hall Medical Center)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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