PregnancyNCT02372266
Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
A study testing Early Maternal-Newborn Infant Discharge and Routine discharge in people with Pregnancy, run by 59th Medical Wing.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Early Maternal-Newborn Infant Discharge and Routine discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,223 participants
- Where
- No sites listed yet
- Study dates
- Apr 1997to Aug 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All pregnant women enrolling for obstetric care at a large military academic health center
Who cannot join
- Planning a move from the area before delivery
- Multiple gestations
- Pre-existing maternal diabetes
- Maternal chronic hypertension
- Maternal age < 18
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Early Maternal-Newborn Infant Discharge, Routine discharge
- Keywords
- Infant, Newborn, hospital discharge, Early newborn discharge, Newborn length of stay, Maternity length of stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Maternal-Newborn Infant DischargeOther
Discharge from the hospital between 12-24 hours of life
Routine dischargeOther
Discharge of the mother and newborn 2 to 3 days after delivery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to the Level II/III neonatal care unit or hospital
All admissions to the Level II/III neonatal care unit following delivery
Measured: 72 hours
Secondary outcomes (21)
Emergency department visits, clinic visits, or hospital admissions
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
Measured: 72 hours
Emergency department visits, clinic visits, or hospital admissions
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
Measured: 14 days
Emergency department visits, clinic visits, or hospital admissions
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
Measured: 8 weeks
Emergency department visits, clinic visits, or hospital admissions
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
Measured: 6 months
Breastfeeding score (5 point Likert scale)
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
Measured: At discharge (12 to 72 hours after delivery)
Breastfeeding score (5 point Likert scale)
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
Measured: 14 days
Breastfeeding score (5 point Likert scale)
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
Measured: 8 weeks
Breastfeeding score (5 point Likert scale)
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
Measured: 6 months
Maternal anxiety (State/Trait Anxiety Inventory)
Measured: At discharge (12 to 72 hours after delivery)
Maternal anxiety (State/Trait Anxiety Inventory)
State/Trait Anxiety Inventory
Measured: 14 days
Maternal depression (Generalized Contentment Scale)
Generalized Contentment Scale
Measured: At discharge (12 to 72 hours after delivery)
Maternal depression (Generalized Contentment Scale)
Generalized Contentment Scale
Measured: 14 days
Maternal confidence (Confidence on a Likert scale)
Confidence on a Likert scale
Measured: At discharge (12 to 72 hours after delivery)
Maternal confidence (Confidence on a Likert scale)
Confidence on a Likert scale
Measured: 14 days
Maternal satisfaction with length of stay (Likert scale)
Satisfaction with length of stay on a Likert scale
Measured: At discharge (12 to 72 hours after delivery)
Maternal satisfaction with length of stay (Likert scale)
Satisfaction with length of stay on a Likert scale
Measured: 14 days
Maternal satisfaction with overall experience (Likert scale)
Satisfaction with overall childbirth experience on a Likert scale
Measured: At discharge (12 to 72 hours after delivery)
Maternal satisfaction with overall experience (Likert scale)
Satisfaction with overall childbirth experience on a Likert scale
Measured: 14 days
Admission to the Level II/III neonatal care unit or hospital
All admissions to the Level II/III neonatal care unit following delivery
Measured: 14 days
Admission to the Level II/III neonatal care unit or hospital
All admissions to the Level II/III neonatal care unit following delivery
Measured: 8 weeks
Admission to the Level II/III neonatal care unit or hospital
All admissions to the Level II/III neonatal care unit following delivery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startApr 1997
- Primary completionJan 2001
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,223 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, William H. Barth, Jr., M.D., Col(ret), USAF, MC, 59th Medical Wing
- Investigators
- William H Barth, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372266
- Sponsor's protocol ID
- SGO 96-042
- Other IDs
- DI950076, FWH19960042H
- Status last verified
- Feb 2015
- First submitted
- 3 Feb 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
- ClinicalTrials.gov ID
- NCT02372266
- Acronym / sponsor ID
- SGO 96-042
- Conditions
- Pregnancy
- Keywords
- Infant, Newborn, hospital discharge, Early newborn discharge, Newborn length of stay, Maternity length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,223 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Study start
- Apr 1997
- Primary completion
- Jan 2001 (actual)
- Study completion
- Aug 2001 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Discharge Group | Experimental | Other: Early Maternal-Newborn Infant DischargeIf 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. |
| Routine Stay Group | Active comparator | Other: Routine dischargeWomen and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women enrolling for obstetric care at a large military academic health center
Key exclusion criteria (5 listed)
- Planning a move from the area before delivery
- Multiple gestations
- Pre-existing maternal diabetes
- Maternal chronic hypertension
- Maternal age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Maternal-Newborn Infant DischargeDischarge from the hospital between 12-24 hours of life | Other | Early Discharge Group |
| Routine dischargeDischarge of the mother and newborn 2 to 3 days after delivery | Other | Routine Stay Group |
Primary outcome
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
21 secondary outcomes
Emergency department visits, clinic visits, or hospital admissions
Time frame: 72 hours
Emergency department visits, clinic visits, or hospital admissions
Time frame: 14 days
Emergency department visits, clinic visits, or hospital admissions
Time frame: 8 weeks
Emergency department visits, clinic visits, or hospital admissions
Time frame: 6 months
Breastfeeding score (5 point Likert scale)
Time frame: At discharge (12 to 72 hours after delivery)
Breastfeeding score (5 point Likert scale)
Time frame: 14 days
Breastfeeding score (5 point Likert scale)
Time frame: 8 weeks
Breastfeeding score (5 point Likert scale)
Time frame: 6 months
Maternal anxiety (State/Trait Anxiety Inventory)
Time frame: At discharge (12 to 72 hours after delivery)
Maternal anxiety (State/Trait Anxiety Inventory)
Time frame: 14 days
Maternal depression (Generalized Contentment Scale)
Time frame: At discharge (12 to 72 hours after delivery)
Maternal depression (Generalized Contentment Scale)
Time frame: 14 days
Maternal confidence (Confidence on a Likert scale)
Time frame: At discharge (12 to 72 hours after delivery)
Maternal confidence (Confidence on a Likert scale)
Time frame: 14 days
Maternal satisfaction with length of stay (Likert scale)
Time frame: At discharge (12 to 72 hours after delivery)
Maternal satisfaction with length of stay (Likert scale)
Time frame: 14 days
Maternal satisfaction with overall experience (Likert scale)
Time frame: At discharge (12 to 72 hours after delivery)
Maternal satisfaction with overall experience (Likert scale)
Time frame: 14 days
Admission to the Level II/III neonatal care unit or hospital
Time frame: 14 days
Admission to the Level II/III neonatal care unit or hospital
Time frame: 8 weeks
Admission to the Level II/III neonatal care unit or hospital
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H Barth, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Early Maternal-Newborn Infant Discharge and Routine discharge in people with Pregnancy, run by 59th Medical Wing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission to the Level II/III neonatal care unit or hospital (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.