Comparison of FAUCS vs. Misgav Ladach
Primary Purpose
Pain, Postoperative, Ambulation Difficulty
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
French Abulatory Cesrean Section
Misgav-Ladach
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring cesarean
Eligibility Criteria
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
Sites / Locations
- Bnai-Zion Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FAUCS
Control
Arm Description
Patients undergoing a cesarean section using the FAUCS technique
Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Length of surgery
The duration of surgery (in minutes) from incision until closure.
Blood loss (ml) during surgery
The estimated volume of blood (in ml) lost during surgery
Birthweight
The weight (grams) of the neonate immediately after birth
Cord pH
The pH measured in a blood sample from the umbilical artery
Birth trauma
The rate of birthtrauma in diagnosed in the neonate (shoulder dystocia, fracture, cerebral hemorrhage, cephalhematoma, etc.)
Full Information
NCT ID
NCT03812406
First Posted
December 19, 2018
Last Updated
January 19, 2019
Sponsor
Bnai Zion Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03812406
Brief Title
Comparison of FAUCS vs. Misgav Ladach
Official Title
Comparison Between French Ambulatory Cesarean Section to The Misgav-Ladach Technique - Double Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2018 (Actual)
Primary Completion Date
August 19, 2019 (Anticipated)
Study Completion Date
September 19, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Ambulation Difficulty
Keywords
cesarean
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FAUCS
Arm Type
Experimental
Arm Description
Patients undergoing a cesarean section using the FAUCS technique
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique
Intervention Type
Procedure
Intervention Name(s)
French Abulatory Cesrean Section
Intervention Description
A cesarean section performed according to the FAUCS technique
Intervention Type
Procedure
Intervention Name(s)
Misgav-Ladach
Intervention Description
A cesarean section performed according to the Misgav Ladach technique
Primary Outcome Measure Information:
Title
Composite maternal adverse outcome
Description
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
Time Frame
24 hours post surgery
Secondary Outcome Measure Information:
Title
Length of surgery
Description
The duration of surgery (in minutes) from incision until closure.
Time Frame
24 hours
Title
Blood loss (ml) during surgery
Description
The estimated volume of blood (in ml) lost during surgery
Time Frame
24 hours
Title
Birthweight
Description
The weight (grams) of the neonate immediately after birth
Time Frame
immediately after birth
Title
Cord pH
Description
The pH measured in a blood sample from the umbilical artery
Time Frame
immediately after birth
Title
Birth trauma
Description
The rate of birthtrauma in diagnosed in the neonate (shoulder dystocia, fracture, cerebral hemorrhage, cephalhematoma, etc.)
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rami Sammour, MD
Phone
+972506267390
Email
rsammour2002@gmail.com
Facility Information:
Facility Name
Bnai-Zion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami Sammour
Phone
0506267390
First Name & Middle Initial & Last Name & Degree
Shlomi Sagie, MD
First Name & Middle Initial & Last Name & Degree
Rami Sammour, MD
First Name & Middle Initial & Last Name & Degree
Israel Hendler, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of FAUCS vs. Misgav Ladach
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