Ambulation Difficulty, Pain, Postoperative
Conditions
Keywords
cesarean
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.
Interventions
PROCEDUREFrench Abulatory Cesrean Section
A cesarean section performed according to the FAUCS technique
PROCEDUREMisgav-Ladach
A cesarean section performed according to the Misgav Ladach technique
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Length of surgery | 24 hours | The duration of surgery (in minutes) from incision until closure. |
| Blood loss (ml) during surgery | 24 hours | The estimated volume of blood (in ml) lost during surgery |
| 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.) |
Countries
Israel
Contacts
Primary ContactRami Sammour, MD
Outcome results
None listed