Status:
COMPLETED
Ambulatory Childbirth Pathway Pilot Feasibility Study
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
December 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05438004
Start Date
December 19 2021
End Date
March 20 2025
Last Update
July 10 2025
Active Locations (1)
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1
Hôpital Archet
Nice, France