Pain, PostoperativeNCT03812406
Comparison of FAUCS vs. Misgav Ladach
A study testing French Abulatory Cesrean Section and Misgav-Ladach in people with Pain, Postoperative and Ambulation Difficulty, run by Bnai Zion Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Ambulation Difficulty
- What is being tested?
- French Abulatory Cesrean Section and Misgav-Ladach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Aug 2018to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients scheduled for a cesarean section
- term pregnancy: 37-42 weeks
- singleton pregnancy
- age 18 and above
- patients capable of signing an informed consent
Who cannot join
- multiple pregnancy
- emergency cesarean
- previous 3 cesareans and above
- placenta accreta
- uterine myomas in the lower segment
- fetal growth restriction
Show all 9Show fewer
- fetal anemia
- preeclampsia
- women scheduled for general anesthesia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai-Zion Medical Center
Haifa
Rami Sammour, 0506267390
Shlomi Sagie, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative, Ambulation Difficulty
- Being tested
- French Abulatory Cesrean Section, Misgav-Ladach
- Keywords
- cesarean
- Medical subject headings
- Pain, Postoperative, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
French Abulatory Cesrean SectionProcedure or surgery
A cesarean section performed according to the FAUCS technique
Misgav-LadachProcedure or surgery
A cesarean section performed according to the Misgav Ladach technique
| Study group | Role | What they receive |
|---|---|---|
| FAUCS | Experimental | Patients undergoing a cesarean section using the FAUCS technique Receives: Procedure: French Abulatory Cesrean Section |
| Control | Active comparator | Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique Receives: Procedure: Misgav-Ladach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours post surgery
Secondary outcomes (5)
Length of surgery
The duration of surgery (in minutes) from incision until closure.
Measured: 24 hours
Blood loss (ml) during surgery
The estimated volume of blood (in ml) lost during surgery
Measured: 24 hours
Birthweight
The weight (grams) of the neonate immediately after birth
Measured: immediately after birth
Cord pH
The pH measured in a blood sample from the umbilical artery
Measured: immediately after birth
Birth trauma
The rate of birthtrauma in diagnosed in the neonate (shoulder dystocia, fracture, cerebral hemorrhage, cephalhematoma, etc.)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start19 Aug 2018
- Primary completion19 Aug 2019 (estimated)
- Study completion19 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812406
- Sponsor's protocol ID
- FAUCS
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sagi S, Bleicher I, Bakhous R, Pelts A, Talhamy S, Caspin O, Sammour R, Sagi-Dain L. Comparison between the modified French AmbUlatory Cesarean Section and standard cesarean technique-a randomized double-blind controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100910. doi: 10.1016/j.ajogmf.2023.100910. Epub 2023 Feb 23.
PubMed 36828283
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between French Ambulatory Cesarean Section to The Misgav-Ladach Technique - Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03812406
- Acronym / sponsor ID
- FAUCS
- Conditions
- Pain, Postoperative, Ambulation Difficulty
- Keywords
- cesarean
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 19 Aug 2018 (actual)
- Primary completion
- 19 Aug 2019 (estimated)
- Study completion
- 19 Sep 2019 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAUCS | Experimental | Procedure: French Abulatory Cesrean SectionPatients undergoing a cesarean section using the FAUCS technique |
| Control | Active comparator | Procedure: Misgav-LadachPatients undergoing a cesarean section using the traditional (Misgav-Ladach) technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients scheduled for a cesarean section
- term pregnancy: 37-42 weeks
- singleton pregnancy
- age 18 and above
- patients capable of signing an informed consent
Key exclusion criteria (9 listed)
- multiple pregnancy
- emergency cesarean
- previous 3 cesareans and above
- placenta accreta
- uterine myomas in the lower segment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| French Abulatory Cesrean SectionA cesarean section performed according to the FAUCS technique | Procedure or surgery | FAUCS |
| Misgav-LadachA cesarean section performed according to the Misgav Ladach technique | Procedure or surgery | Control |
Primary outcome
Composite maternal adverse outcome
Time frame: 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
5 secondary outcomes
Length of surgery
Time frame: 24 hours
Blood loss (ml) during surgery
Time frame: 24 hours
Birthweight
Time frame: immediately after birth
Cord pH
Time frame: immediately after birth
Birth trauma
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 36828283Sagi S, Bleicher I, Bakhous R, Pelts A, Talhamy S, Caspin O, Sammour R, Sagi-Dain L. Comparison between the modified French AmbUlatory Cesarean Section and standard cesarean technique-a randomized double-blind controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100910. doi: 10.1016/j.ajogmf.2023.100910. Epub 2023 Feb 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing French Abulatory Cesrean Section and Misgav-Ladach in people with Pain, Postoperative and Ambulation Difficulty, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rami Sammour, MD (+972506267390, rsammour2002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite maternal adverse outcome (time frame: 24 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03812406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.