Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

Pregnancy Clinical Trial

Official title:

A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372266
• Other study ID #: SGO 96-042
• Secondary ID: DI950076FWH19960
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: February 19, 2015
• Start date: April 1997
• Est. completion date: August 2001

Study information

• Verified date: February 2015
• Source: Wilford Hall Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2223
• Est. completion date: August 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Early Maternal-Newborn Infant Discharge
Discharge from the hospital between 12-24 hours of life
• Routine discharge
Discharge of the mother and newborn 2 to 3 days after delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wilford Hall Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	72 hours	Yes
Secondary	Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	14 days	Yes
Secondary	Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	8 weeks	No
Secondary	Emergency department visits, clinic visits, or hospital admissions	Any unplanned pediatric visit to an emergency room, clinic or a hospital admission	6 months	No
Secondary	Breastfeeding score (5 point Likert scale)	5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle	At discharge (12 to 72 hours after delivery)	No
Secondary	Breastfeeding score (5 point Likert scale)	5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle	14 days	No
Secondary	Breastfeeding score (5 point Likert scale)	5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle	8 weeks	No
Secondary	Breastfeeding score (5 point Likert scale)	5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle	6 months	No
Secondary	Maternal anxiety (State/Trait Anxiety Inventory)		At discharge (12 to 72 hours after delivery)	No
Secondary	Maternal anxiety (State/Trait Anxiety Inventory)	State/Trait Anxiety Inventory	14 days	No
Secondary	Maternal depression (Generalized Contentment Scale)	Generalized Contentment Scale	At discharge (12 to 72 hours after delivery)	No
Secondary	Maternal depression (Generalized Contentment Scale)	Generalized Contentment Scale	14 days	No
Secondary	Maternal confidence (Confidence on a Likert scale)	Confidence on a Likert scale	At discharge (12 to 72 hours after delivery)	No
Secondary	Maternal confidence (Confidence on a Likert scale)	Confidence on a Likert scale	14 days	No
Secondary	Maternal satisfaction with length of stay (Likert scale)	Satisfaction with length of stay on a Likert scale	At discharge (12 to 72 hours after delivery)	No
Secondary	Maternal satisfaction with length of stay (Likert scale)	Satisfaction with length of stay on a Likert scale	14 days	No
Secondary	Maternal satisfaction with overall experience (Likert scale)	Satisfaction with overall childbirth experience on a Likert scale	At discharge (12 to 72 hours after delivery)	No
Secondary	Maternal satisfaction with overall experience (Likert scale)	Satisfaction with overall childbirth experience on a Likert scale	14 days	No
Secondary	Admission to the Level II/III neonatal care unit or hospital	All admissions to the Level II/III neonatal care unit following delivery	14 days	Yes
Secondary	Admission to the Level II/III neonatal care unit or hospital	All admissions to the Level II/III neonatal care unit following delivery	8 weeks	Yes
Secondary	Admission to the Level II/III neonatal care unit or hospital	All admissions to the Level II/III neonatal care unit following delivery	6 months	No