Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT05438004
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).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05438004
Study Brief:
Protocol Section:
NCT05438004