Clinical trial NCT03741907: Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques
Official title: French Ambulatory and Misgav Ladach Cesarean Section Techniques : a Results of a Comparative Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean
Surgery
Birth
Recovery
Outcomes
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the last decades cesarean section rates are getting higher in many countries. The rise in those rates encourages obstetricians to improve operative techniques for a better maternal and fetal outcome.

Despite its worldwide spread, a general consensus on the most appropriate technique to use has not yet been reached.

The most known surgical technique is the MLC . A modified extraperitoneal method of caesarean section :" French Ambulatory Cesarean Section ( FAUCS) was described in the middle of the 90's by "Denis Fauck" and "Jacques Henri Ravina " However, no study comparing these two cesarean techniques was conducted. From where the investigators initiate this study .

Detailed description: Caesarean Section (CS) is one of the most commonly performed operations worldwide The rate of CS continues to rise, despite initiatives to counter this trend. Cesarean sections have a higher morbidity rate than vaginal deliveries, with a substantial care and cost measurable by the mean hospital stay, the use of analgesics, and the potential for complications . Crucially, the birth of a new baby is an unique incentive to return quickly to "normal" function. Improving the cesarean section techniques is therefore of considerable importance in modern obstetrics.

One of the most widely used cesarean section techniques is the MLC method developed by Michael Stark et al. This approach is indicated as the optimal technique in view of its characteristic of reducing lower pelvic discomfort and pain, thus improving quality of life However, this intraperitoneal C-section interfere at least with future fertility desire.

The French Ambulatory Cesarean Section (FAUCS) technique has been employed by 10 practitioners in France for approximately 20 years. In a retrospective study over 3000 cases this innovative approach seems to provide a shorter recovery time with a Hospital discharge the day after surgery . Investigators introduced this technique in "Mongi Slim" university hospital in January 2018. In this study, investigators compare the FAUCS and the MLC techniques in termes of mother and child outcomes

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* gestational age of at least 37 weeks of amenorrhea
* indication of elective cesarean delivery mode (breech presentation ; Fetal macrosomia ; Placenta previa)

Exclusion Criteria:

* Fetal pathology diagnosed prenatally( intrauterine growth restriction , malformation, genetic pathology ... )
* Morbidity adherent placenta
* emergency Cesarean section

Primary outcomes:
measure: changes in post operative pain
timeFrame: 6 hours ; 12 hours , 18 hours , 24 hours
measure: delay to hospital discharge
timeFrame: up to 72 hours
Secondary outcomes:
measure: blood loss
timeFrame: the day before surgery and the day after surgery (24 hours)
measure: operation time
timeFrame: during the surgery
measure: rate of short term incidents
timeFrame: during the surgery and 24 hours after surgery
measure: patient autonomy questionnaire
timeFrame: up to 48 hours after surgery
measure: newborn overall condition
timeFrame: 5 minutes from birth
measure: neonatal acid base balance
timeFrame: immediately after fetal extraction
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Kaouther Dimassi
state: Sidi Daoued La Marsa
Study officials:
affiliation: University Tunis El Manar , Faculty of medicine Tunis
name: kaouther dimassi, MD
role: PRINCIPAL_INVESTIGATOR
References: