Ambulatory Childbirth Pathway Pilot Feasibility Study

NCT05438004 | Completed

• 1 other identifier: 19-PP-10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Ambulatory; Childbirth

Outcome Measures

Primary Outcomes (1)

• Emergency visits

  Percentage of emergency visits for neonatal or maternal reasons within one month of delivery

  one month

Secondary Outcomes (5)

• post partum recommendations

  one month

• Breastfeading rate

  one month

• Maternal pain

  Day 2

• Satisfaction score

  One month

• Cost of outpatient care

  one month

Study Arms (1)

Ambulatory nice birth

EXPERIMENTAL

Discharge from the maternity ward from the 2nd hour and before the 24th hour following an uncomplicated delivery

Other: Ambulatory nice birth

Interventions

Ambulatory nice birth OTHER

discharge from the maternity ward from the 2nd hour and before the 24th hour following an uncomplicated delivery

Ambulatory nice birth

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital Archet

Nice, France

Location

Related Publications (1)

• Gauci PA, Adrados C, Albouy C, Roy M, Walrave Y, Marioli S, Benamer L, Delotte J. Implementation of early postnatal discharge within 24 h in France: Safety, satisfaction, and feasibility trial supported by a connected home monitoring application (NICE-BIRTH study). Women Birth. 2026 Apr 24;39(3):102205. doi: 10.1016/j.wombi.2026.102205. Online ahead of print.

  PMID: 42034097 RESULT

Study Officials

• Pierre-Alexis GAUCI, MD-PHD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: December 19, 2021
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: May 26, 2026

Record last verified: 2025-07

Locations

FR (1)