Pilot program for early discharge after childbirth

NICE BIRTH - Ambulatory Childbirth Pathway Pilot Feasibility Study

This study is testing a new program that lets low-risk mothers go home shortly after giving birth to see if it’s safe and helps them and their babies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 1 site (Nice)
• Trial ID: NCT05438004 on ClinicalTrials.gov

What this trial studies

This pilot program aims to assess the feasibility of an ambulatory childbirth pathway that allows low-risk mothers to return home shortly after vaginal delivery. The initiative is based on the premise that with proper organization of discharge and follow-up care, a shorter hospital stay can be safe for both mothers and newborns. The study will evaluate maternal and neonatal health outcomes, as well as the support systems in place for families post-discharge. By focusing on low-risk pregnancies, the program seeks to optimize hospital resources and improve patient satisfaction.

Who should consider this trial

Good fit: Ideal candidates include low-risk pregnant women who are of legal age, have a vaginal delivery, and can ensure support at home post-discharge.

Not a fit: Patients with social isolation, psychiatric disorders, or those requiring hospitalization due to complications will not benefit from this program.

Why it matters

Potential benefit: If successful, this program could lead to safer and more efficient early discharges for low-risk mothers and their newborns.

How similar studies have performed: Other countries have successfully implemented similar early discharge programs for low-risk deliveries, suggesting potential for success in this approach.

Eligibility criteria

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

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).

Where this trial is running

Nice

• Hôpital Archet — Nice, France (Recruiting)

Study contacts

• Principal investigator: Caroline ADRADOS — Centre Hospitalier Universitaire de Nice
• Study coordinator: Caroline ADRADOS

Conditions Pregnancy Related; Ambulatory; Childbirth