Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques (MLC)

University Tunis El Manar

Status: Completed

Conditions: Cesarean Section

Treatments: Procedure: MLC; Procedure: FAUCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03741907

FAUCS MongiSlim

Details and patient eligibility

About

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 .

Full 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

Enrollment: 100 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

FAUCS

Experimental group

Description:

French Ambulatory C-section

Treatment:

Procedure: FAUCS

MLC

Active Comparator group

Description:

Gold Standard

Treatment:

Procedure: MLC