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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Rami Sammour, MD contact

+972506267390

rsammour2002@gmail.com

Israel1 site, 1 recruiting

  • Bnai-Zion Medical Center

    Haifa

    Rami Sammour, 0506267390

    Shlomi Sagie, MD

    Recruiting

Other trials in Israel

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.

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 groups in NCT03812406
Study groupRoleWhat they receive
FAUCSExperimentalPatients undergoing a cesarean section using the FAUCS technique
Receives: Procedure: French Abulatory Cesrean Section
ControlActive comparatorPatients 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.

  1. 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)

  1. Length of surgery

    The duration of surgery (in minutes) from incision until closure.

    Measured: 24 hours

  2. Blood loss (ml) during surgery

    The estimated volume of blood (in ml) lost during surgery

    Measured: 24 hours

  3. Birthweight

    The weight (grams) of the neonate immediately after birth

    Measured: immediately after birth

  4. Cord pH

    The pH measured in a blood sample from the umbilical artery

    Measured: immediately after birth

  5. 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.

  1. First posted23 Jan 2019
  2. Study start19 Aug 2018
  3. Primary completion19 Aug 2019 (estimated)
  4. Study completion19 Sep 2019 (estimated)

Resources

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)
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

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.

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