Comparison of FAUCS vs. Misgav Ladach

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812406
• Other study ID #: FAUCS
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2018
• Est. completion date: September 19, 2019

Study information

• Verified date: December 2018
• Source: Bnai Zion Medical Center
• Contact: Rami Sammour, MD
• Phone: +972506267390
• Email: rsammour2002[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulation Difficulty
• Mobility Limitation
• Pain, Postoperative

Intervention

Procedure:
• French Abulatory Cesrean Section
A cesarean section performed according to the FAUCS technique
• Misgav-Ladach
A cesarean section performed according to the Misgav Ladach technique

Locations

Country	Name	City	State
Israel	Bnai-Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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