Comparison of FAUCS vs. Misgav Ladach

Not Applicable

• Conditions: Ambulation Difficulty; Pain, Postoperative
• Interventions: Procedure: French Abulatory Cesrean Section; Procedure: Misgav-Ladach

• Registration Number: NCT03812406
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-08-19
• Status Verified: 2018-12
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2019-01-19
• Last Update Submitted: 2019-01-19
• Study First Posted: 2019-01-23
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-08-19
• Study Completion: 2019-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FAUCS	French Abulatory Cesrean Section	Patients undergoing a cesarean section using the FAUCS technique
Control	Misgav-Ladach	Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique

Primary Outcome Measures

Name	Time	Method
Composite maternal adverse outcome	24 hours post surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bnai-Zion Medical Center; 🇮🇱 Haifa, Israel