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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05438004




Registration number
NCT05438004
Ethics application status
Date submitted
24/06/2022
Date registered
29/06/2022
Date last updated
1/10/2024

Titles & IDs
Public title
Ambulatory Childbirth Pathway Pilot Feasibility Study
Scientific title
NICE BIRTH - Ambulatory Childbirth Pathway Pilot Feasibility Study
Secondary ID [1] 0 0
19-PP-10
Universal Trial Number (UTN)
Trial acronym
NICE BIRTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy Related 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ambulatory nice birth

Experimental: Ambulatory nice birth - Discharge from the maternity ward from the 2nd hour and before the 24th hour following an uncomplicated delivery


Other interventions: Ambulatory nice birth
discharge from the maternity ward from the 2nd hour and before the 24th hour following an uncomplicated delivery
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Emergency visits
Timepoint [1] 0 0
one month
Secondary outcome [1] 0 0
post partum recommendations
Timepoint [1] 0 0
one month
Secondary outcome [2] 0 0
Breastfeading rate
Timepoint [2] 0 0
one month
Secondary outcome [3] 0 0
Maternal pain
Timepoint [3] 0 0
Day 2
Secondary outcome [4] 0 0
Satisfaction score
Timepoint [4] 0 0
One month
Secondary outcome [5] 0 0
Cost of outpatient care
Timepoint [5] 0 0
one month

Eligibility
Key inclusion criteria
* Maternal:
* Voluntary
* Legal age
* Vaginal delivery
* General Health Insurance Plan
* Accompanying person present at discharge and every day during the first 2 days
* Pain VAS < 5 with or without simple analgesics
* Mother-child interaction judged satisfactory by the team
* Signature of consent
* Pediatric :
* Singleton
* > 38 weeks of amenorrhea
* Eutrophic
* Apgar > 7 at 5 minutes of life
* Respiratory rate < 60/min; 90bpm < Heart rate < 170bpm; SaO2 >95
* Axillary temperature between 36 and 37°C
* Feeding established
* Vitamin K1 given
* Neonatal screenings organized
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Maternal:
* Social isolation, psychiatric disorder with impact on infant care, moderate to severe (according to DSM5) substance use disorder
* Poorly balanced chronic condition requiring hospitalization
* Postpartum complications requiring hospitalization
* Postpartum hemorrhage > 500mL
* Body temperature > 38.0°C without paracetamol
* Thromboembolic signs: pain, edema, positive Homans sign
* Protected persons defined in the following articles of the public health code:

L. 1121-6: persons deprived of liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social institution for purposes other than research; L. 1121-8: adults subject to a legal protection measure or unable to express their consent; L. 1122-1-2: persons in emergency situations unable to give prior consent.

* Pediatric :
* Jaundice
* Risk factor for neonatal infection (maternal streptococcal B colonization during the current pregnancy, history of neonatal streptococcal B infection in a previous pregnancy, duration of rupture of membranes > 12 hours, maternal temperature > 38.0°C intrapartum or during the 2 hours following delivery).

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Nice

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Hospitalier Universitaire de Nice
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Caroline ADRADOS
Address 0 0
Centre Hospitalier Universitaire de Nice
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Caroline ADRADOS
Address 0 0
Country 0 0
Phone 0 0
04.92.03.60.92
Fax 0 0
Email 0 0
adrados.c@chu-nice.fr
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05438004