A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- 59th Medical Wing
- Enrollment
- 2223
- Primary Endpoint
- Admission to the Level II/III neonatal care unit or hospital
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Detailed 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.
Investigators
William H. Barth, Jr., M.D., Col(ret), USAF, MC
Chairman, Department of Obstetrics and Gynecology
59th Medical Wing
Eligibility Criteria
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
Outcomes
Primary Outcomes
Admission to the Level II/III neonatal care unit or hospital
Time Frame: 72 hours
All admissions to the Level II/III neonatal care unit following delivery
Secondary Outcomes
- Breastfeeding score (5 point Likert scale)(6 months)
- Maternal confidence (Confidence on a Likert scale)(14 days)
- Emergency department visits, clinic visits, or hospital admissions(6 months)
- Maternal satisfaction with overall experience (Likert scale)(14 days)
- Admission to the Level II/III neonatal care unit or hospital(6 months)
- Maternal depression (Generalized Contentment Scale)(14 days)
- Maternal anxiety (State/Trait Anxiety Inventory)(14 days)
- Maternal satisfaction with length of stay (Likert scale)(14 days)