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Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

19. februar 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

2223

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Annen: Routine discharge
Discharge of the mother and newborn 2 to 3 days after delivery

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

59th Medical Wing

Etterforskere

  • Hovedetterforsker: William H Barth, MD, Massachusetts General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 1997

Primær fullføring (Faktiske)

1. januar 2001

Studiet fullført (Faktiske)

1. august 2001

Datoer for studieregistrering

Først innsendt

3. februar 2015

Først innsendt som oppfylte QC-kriteriene

19. februar 2015

Først lagt ut (Anslag)

26. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. februar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. februar 2015

Sist bekreftet

1. februar 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

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