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 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT00727935
Eligibility Criteria:
Pre-inclusion criteria :
* Assent of participation in the study signed
* Major parturient (\> 18 years) in the course of work in room of childbirth
* Mono-foetal pregnancy
* Presentation at the top
Inclusion Criteria:
* Checking of the criteria of pre-inclusion
* Oral confirmation of the assent of the patient
* ASA 1 or 2
* Childbirth by low way
* Patient having an epidural analgesia
* Patient having an episiotomy
* Counter-indication with the ropivacaïne
Pre-exclusion criteria :
* Absence of signed assent of participation in the study
* Counter indication with the lidocaïne
* General counter-indications suitable for the epidural anaesthesia , independently of the local anaesthetic used
* Counter-indications with the infiltration: patient under anticoagulants, coagulopathy
* Allergy to the lidocaine or the ropivacaine
* Allergy to the one of analgesics per bones used in the assumption of responsibility of routine
* Severe insufficiency hepatic and/or renal and/or ulcerates gastro-duodénal (in the case of anti-inflammatory drug regulation not steroid during the postpartum)
* Minor
* Major protected within the meaning of the law Huriet
* Patient during one time of exclusion following another biomedical study
Exclusion Criteria:
* Absence of oral confirmation of the assent of the patient
* Infection or ignition of the point of puncture
* Analgesia epidural not functional
* Dural breach
* Appearance of ascribable side effects to only the anaesthetic buildings at the time of epidural analgesia
* Median Episiotomy (increased risk of lesions of the sphincter)
* Need for an instrumentation at the time of expulsion
* Haemorrhage of the delivery requiring a blood transfusion and/or general anaesthesia in urgency with surgical operation for haemostasis
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00727935
Study Brief:
Protocol Section:
NCT00727935