Comparison of FAUCS vs. Misgav Ladach

Study Overview
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Brief Summary
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This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such comparison has not been done so far, and this study will examined if indeed the FAUCS techniques offers any advantages.

Detailed Description
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The FAUCS technique for performing a cesarean section has been described by a French group several years ago, and is claimed to reduce postoperative pain and increase ambulation. With this technique, after making the transverse skin incision, the fascia is opened vertically and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally, and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the reduced incision size, a special spatula is used to facilitate extraction of the fetal head in some cases. No urinary catheter is used during or after the operation, and fluid administration is restricted during the procedure. The patient is encouraged to get out of bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for analgesics, ambulation, neonatal outcome, and perioperative complications.

Official Title
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Comparison Between French Ambulatory Cesarean Section to The Misgav-Ladach Technique - Double Blind Randomized Controlled Trial

Conditions
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Pain, Postoperative, Ambulation Difficulty

Intervention / Treatment
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* Procedure: French Abulatory Cesrean Section
* Procedure: Misgav-Ladach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for a cesarean section term pregnancy: 37-42 weeks singleton pregnancy age 18 and above patients capable of signing an informed consent Exclusion Criteria: multiple pregnancy emergency cesarean previous 3 cesareans and above placenta accreta uterine myomas in the lower segment fetal growth restriction fetal anemia preeclampsia women scheduled for general anesthesia

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAUCS<br>Patients undergoing a cesarean section using the FAUCS technique | Procedure: French Abulatory Cesrean Section<br>* A cesarean section performed according to the FAUCS technique<br>|
| Active Comparator: Control<br>Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique | Procedure: Misgav-Ladach<br>* A cesarean section performed according to the Misgav Ladach technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite maternal adverse outcome | The rate of women with a composite maternal adverse outcome, defined as at least one of the following: Visual Analogue Scale score >6 (scale of 1-10, 1 being a very mild pain, 10 being the worst pain imagineable) at 3-4 hours post surgery, inability to ambulate 3-4 hours post surgery, and QoR15 (Quality of Recovery) score < 90 (range 0 to 150, 150 being the best recovery after surgery) at 24 hours post surgery | 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of surgery | The duration of surgery (in minutes) from incision until closure. | 24 hours | 
| Blood loss (ml) during surgery | The estimated volume of blood (in ml) lost during surgery | 24 hours | 
| Birthweight | The weight (grams) of the neonate immediately after birth | immediately after birth | 
| Cord pH | The pH measured in a blood sample from the umbilical artery | immediately after birth | 
| Birth trauma | The rate of birthtrauma in diagnosed in the neonate (shoulder dystocia, fracture, cerebral hemorrhage, cephalhematoma, etc.) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean