Comparison of FAUCS vs. Misgav Ladach

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Ambulation Difficulty
• Intervention / Treatment: Procedure: French Abulatory Cesrean Section; Procedure: Misgav-Ladach

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rami Sammour, MD; Phone Number: +972506267390; Email: rsammour2002@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Bnai-Zion Medical Center
    • Contact: Rami Sammour; Phone Number: 0506267390
    • Principal Investigator: Shlomi Sagie, MD
    • Sub-Investigator: Rami Sammour, MD
    • Sub-Investigator: Israel Hendler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2018
• Primary Completion (Anticipated): August 19, 2019
• Study Completion (Anticipated): September 19, 2019

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 19, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: cesarean
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Mobility Limitation
• Other Study ID Numbers: FAUCS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No