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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT02905695
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria:
* Patients aged 18-45 years
* Single pregnancy.
* Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.
* Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.
* Patients affiliated to a national insurance scheme
* Patients who have given their written consent
Exclusion Criteria:
* Patient not speaking, reading, writing French.
* Multiple pregnancy.
* Breech delivery or instrumental delivery by forceps or spatula.
* Intact perineum.
* No epidural analgesia.
* Patient who represent contraindication to local anesthetics, severe arterial hypotension.
* Previous tear requiring sutures.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02905695
Study Brief:
Protocol Section:
NCT02905695