EUCTR2013-001850-83-FR
Active, Not Recruiting
Phase 1
Adaptation to neonatal life after an anesthetic protocol using remifentanil for general anesthesia for caesarean section in a context of prematurity - REAGI Protocol (Remifentanil for General Anesthesia in the context of Immaturity) - REAGI
CHU- Hôpitaux de Rouen0 sites60 target enrollmentSeptember 24, 2015
Conditionspregnant woman older than 18 years with an indication for caesarean section under general anesthesia in a context of prematurity.MedDRA version: 18.0Level: HLGTClassification code 10026908Term: Maternal complications of pregnancySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Drugsultiva
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- pregnant woman older than 18 years with an indication for caesarean section under general anesthesia in a context of prematurity.
- Sponsor
- CHU- Hôpitaux de Rouen
- Enrollment
- 60
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria of the mother:
- •\- Patient over 18 years
- •\- Single pregnancy with an indication for cesarean section under general anesthesia context of prematurity (\<37SA)
- •\- Patient informed and written consent for participation in this research signed
- •\- Affiliation to social security
- •Inclusion criteria of the child:
- •Parents informed and written consent signed by the father and mother for the participation in this research by the child (unless a parent no longer has parental authority)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Non\-inclusion criteria of the mother:
- •\- Vaginal Delivery
- •\- Mother pathology requiring the use of an opioid during induction
- •\- Severe Preeclampsia
- •\- More than 14 weeks between the information and the inclusion
- •\- Patient under guardianship
- •Non\-inclusion criteria of the child:
- •Fetal pathology diagnosed in the prenatal period involving the prognosis of the child
Outcomes
Primary Outcomes
Not specified
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