Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT05438004
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2022-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ambulatory Childbirth Pathway Pilot Feasibility Study
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Study Overview
Official Title:
NICE BIRTH - Ambulatory Childbirth Pathway Pilot Feasibility Study
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICE BIRTH
Brief Summary:
In 2016, according to the national perinatal survey, the average length of stay in maternity hospitals in France after a vaginal delivery was 4.0 days, confirming the decrease in this length of stay compared with previous surveys, but placing France among the Western countries with the longest stay.
Several countries that have further reduced the average length of stay offer low-risk populations a return home in the first few hours after delivery.
As early as 2014, the Haute Autorité de Santé reminded us that "once low risk is defined, the length of stay in the maternity hospital is not discriminating for the safety of the mother and the newborn. The optimal length of stay would rather depend on the organization of the discharge from the maternity hospital, the medical follow-up and the subsequent support".
The studies against a very early discharge are the result of experiments that do not define low risk, and/or do not propose home support.
This pilot study aims to provide a framework for a care pathway allowing discharge from the maternity hospital from the 2nd hour and before the 24th hour following an uncomplicated delivery. Its main objective is to show that such a care pathway allows to respect the French postpartum recommendations, while answering a legitimate expectation of personalization of the care offered to women wishing to be monitored at home earlier after the delivery. It also studies the complications, tolerance, satisfaction and cost of such care.
This is a non-randomized cohort study. It studies 100 voluntary mother-newborn couples, after a delivery at the Nice University Hospital, meeting objective criteria of low risk. A daily follow-up is ensured by a liberal midwife during the first 3 days. The link between the patient, the private midwife and the maternity hospital is maintained permanently thanks to a free dedicated mobile application. This application, equipped with an alert system, is an additional guarantee of compliance with the recommendations for screening and mandatory procedures. It allows for a safer transfer of hospital care to ambulatory care, while providing personalized care tailored to the patient's expectations.
This pilot study would be the beginning of a larger study demonstrating the non-inferiority of such a care pathway compared to the most common management requiring a stay of several days in a maternity hospital.
Several countries that have further reduced the average length of stay offer low-risk populations a return home in the first few hours after delivery.
As early as 2014, the Haute Autorité de Santé reminded us that "once low risk is defined, the length of stay in the maternity hospital is not discriminating for the safety of the mother and the newborn. The optimal length of stay would rather depend on the organization of the discharge from the maternity hospital, the medical follow-up and the subsequent support".
The studies against a very early discharge are the result of experiments that do not define low risk, and/or do not propose home support.
This pilot study aims to provide a framework for a care pathway allowing discharge from the maternity hospital from the 2nd hour and before the 24th hour following an uncomplicated delivery. Its main objective is to show that such a care pathway allows to respect the French postpartum recommendations, while answering a legitimate expectation of personalization of the care offered to women wishing to be monitored at home earlier after the delivery. It also studies the complications, tolerance, satisfaction and cost of such care.
This is a non-randomized cohort study. It studies 100 voluntary mother-newborn couples, after a delivery at the Nice University Hospital, meeting objective criteria of low risk. A daily follow-up is ensured by a liberal midwife during the first 3 days. The link between the patient, the private midwife and the maternity hospital is maintained permanently thanks to a free dedicated mobile application. This application, equipped with an alert system, is an additional guarantee of compliance with the recommendations for screening and mandatory procedures. It allows for a safer transfer of hospital care to ambulatory care, while providing personalized care tailored to the patient's expectations.
This pilot study would be the beginning of a larger study demonstrating the non-inferiority of such a care pathway compared to the most common management requiring a stay of several days in a maternity hospital.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: