An interventional study of French Abulatory Cesrean Section and Misgav-Ladach in Pain, Postoperative and Ambulation Difficulty, sponsored by Bnai Zion Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-23.
Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 120 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Patients undergoing a cesarean section using the FAUCS technique
Procedure: French Abulatory Cesrean Section
Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique
Procedure: Misgav-Ladach
A cesarean section performed according to the FAUCS technique
A cesarean section performed according to the Misgav Ladach technique
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
Time frame: 24 hours post surgery
Length of surgery
The duration of surgery (in minutes) from incision until closure.
Time frame: 24 hours
Blood loss (ml) during surgery
The estimated volume of blood (in ml) lost during surgery
Time frame: 24 hours
Birthweight
The weight (grams) of the neonate immediately after birth
Time frame: immediately after birth
Cord pH
The pH measured in a blood sample from the umbilical artery
Time frame: immediately after birth
Birth trauma
The rate of birthtrauma in diagnosed in the neonate (shoulder dystocia, fracture, cerebral hemorrhage, cephalhematoma, etc.)
Time frame: 24 hours
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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