Cesarean Section; Dehiscence, Extra Peritoneal Caesarean Section
Conditions
Brief summary
The main objective of this study is to compare the time taken to obtain street fitness status for women after extraperitoneal cesarean section compared to women after a classic cesarean section.
Interventions
PROCEDURECaesarean
Two different caesarean section techniques : intra or extraperitoneal
Sponsors
European Clinical Trial Experts Network
Ramsay Générale de Santé
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for a caesarean between 38 and 42 weeks pregnant * Patient aged between 18 and 42 years old * Singleton * Caesarean section with a theoretical operating time \< 1 hour (without major complications) * Patient affiliated to a social security scheme * Patient having signed the free and informed consent.
Exclusion criteria
* BMI \> 40 * High blood pressure treated intravenously * Pre-existing diabetes in pregnancy * Allergy to analgesics * Prenatal depression * Pathological insertion of the placenta (placenta previa or accreta). * History of major pelvic or abdominal surgery (myomectomy, peritonitis) other than caesarean section or minor surgery. * Addiction (drugs) * Pre-existing psychiatric pathology leading to a risk of impaired judgment or behavior. * Patient participating in another clinical study with a drug or medical device * Protected patient: Adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * Patient hospitalized without consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The postoperative time in hours from which the patient stably fulfills the criteria for street fitness. | 1 month | These criteria are defined in the Chung score. This score is between 0 and 10 and evaluate the vital signs, wandering, nausea or vomits, pain and surgical bleeding. |
Countries
France
Contacts
Primary ContactJean-François Oudet
Backup ContactMarie-Hélène Barba
Outcome results
None listed