Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques

Study Overview
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Brief Summary
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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
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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

Official Title
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French Ambulatory and Misgav Ladach Cesarean Section Techniques : a Results of a Comparative Randomized Trial.

Conditions
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Cesarean Section

Intervention / Treatment
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* Procedure: FAUCS
* Procedure: MLC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAUCS<br>French Ambulatory C-section | Procedure: FAUCS<br>* extraperitoneal cesarean with a paramedian left section<br>* Other names: French Ambulatory Cesarean section;|
| Active Comparator: MLC<br>Gold Standard | Procedure: MLC<br>* Gold standard<br>* Other names: Misgav Ladach Method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in post operative pain | changes in postoperative analgesic requirements, changes in self reported pain using the Visual Analog Scale for Pain (VAS Pain) intensity ( The pain VAS is a single-item scale.For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale] ) | 6 hours ; 12 hours , 18 hours , 24 hours | 
| delay to hospital discharge | report of total days spent in hospital after surgery | up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | change in hemoglobin and hematocrit rate | the day before surgery and the day after surgery (24 hours) | 
| operation time | total operation time ; time to fetal extraction ; time to uterine sutures | during the surgery | 
| rate of short term incidents | rate of hemorrhage, rate of transfusion, rate of bladder injury | during the surgery and 24 hours after surgery | 
| patient autonomy questionnaire | time to first spontaneous miction, time to stand up ; time to first complete meal, time to first breastfeeding | up to 48 hours after surgery | 
| newborn overall condition | Apgar score ( The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an ackronym (Appearance, Pulse, Grimace, Activity, Respiration).he test is generally done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.) | 5 minutes from birth | 
| neonatal acid base balance | Cord blood gases | immediately after fetal extraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean, Surgery, Birth, Recovery, Outcomes