Cesarean SectionMLCNCT03741907
Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques
A study testing FAUCS and MLC in people with Cesarean Section, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
In the last decades cesarean section rates are getting higher in many countries. The rise in those rates encourages obstetricians to improve operative techniques for a better maternal and fetal outcome. Despite its worldwide spread, a general consensus on the most appropriate technique to use has not yet been reached. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- FAUCS and MLC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 27 Aug 2018to 30 Apr 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 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy
- gestational age of at least 37 weeks of amenorrhea
- indication of elective cesarean delivery mode (breech presentation ; Fetal macrosomia ; Placenta previa)
Who cannot join
- Fetal pathology diagnosed prenatally( intrauterine growth restriction , malformation, genetic pathology ... )
- Morbidity adherent placenta
- emergency Cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French Ambulatory and Misgav Ladach Cesarean Section Techniques : a Results of a Comparative Randomized Trial.
In the last decades cesarean section rates are getting higher in many countries. The rise in those rates encourages obstetricians to improve operative techniques for a better maternal and fetal outcome.
Despite its worldwide spread, a general consensus on the most appropriate technique to use has not yet been reached.
The most known surgical technique is the MLC . A modified extraperitoneal method of caesarean section :" French Ambulatory Cesarean Section ( FAUCS) was described in the middle of the 90's by "Denis Fauck" and "Jacques Henri Ravina " However, no study comparing these two cesarean techniques was conducted. From where the investigators initiate this study .
Read the detailed description
Caesarean Section (CS) is one of the most commonly performed operations worldwide The rate of CS continues to rise, despite initiatives to counter this trend. Cesarean sections have a higher morbidity rate than vaginal deliveries, with a substantial care and cost measurable by the mean hospital stay, the use of analgesics, and the potential for complications . Crucially, the birth of a new baby is an unique incentive to return quickly to "normal" function. Improving the cesarean section techniques is therefore of considerable importance in modern obstetrics.
One of the most widely used cesarean section techniques is the MLC method developed by Michael Stark et al. This approach is indicated as the optimal technique in view of its characteristic of reducing lower pelvic discomfort and pain, thus improving quality of life However, this intraperitoneal C-section interfere at least with future fertility desire.
The French Ambulatory Cesarean Section (FAUCS) technique has been employed by 10 practitioners in France for approximately 20 years. In a retrospective study over 3000 cases this innovative approach seems to provide a shorter recovery time with a Hospital discharge the day after surgery . Investigators introduced this technique in "Mongi Slim" university hospital in January 2018. In this study, investigators compare the FAUCS and the MLC techniques in termes of mother and child outcomes
- Conditions
- Cesarean Section
- Being tested
- FAUCS, MLC
- Keywords
- Cesarean, Surgery, Birth, Recovery, Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAUCSProcedure or surgery
Also called French Ambulatory Cesarean section
extraperitoneal cesarean with a paramedian left section
MLCProcedure or surgery
Also called "Misgav Ladach" Method
Gold standard
| Study group | Role | What they receive |
|---|---|---|
| FAUCS | Experimental | French Ambulatory C-section Receives: Procedure: FAUCS |
| MLC | Active comparator | Gold Standard Receives: Procedure: MLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in post operative pain
changes in postoperative analgesic requirements, changes in self reported pain using the Visual Analog Scale for Pain (VAS Pain) intensity ( The pain VAS is a single-item scale.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale] )
Measured: 6 hours ; 12 hours , 18 hours , 24 hours
delay to hospital discharge
report of total days spent in hospital after surgery
Measured: up to 72 hours
Secondary outcomes (6)
blood loss
change in hemoglobin and hematocrit rate
Measured: the day before surgery and the day after surgery (24 hours)
operation time
total operation time ; time to fetal extraction ; time to uterine sutures
Measured: during the surgery
rate of short term incidents
rate of hemorrhage, rate of transfusion, rate of bladder injury
Measured: during the surgery and 24 hours after surgery
patient autonomy questionnaire
time to first spontaneous miction, time to stand up ; time to first complete meal, time to first breastfeeding
Measured: up to 48 hours after surgery
newborn overall condition
Apgar score ( The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an ackronym (Appearance, Pulse, Grimace, Activity, Respiration).he test is generally done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.)
Measured: 5 minutes from birth
neonatal acid base balance
Cord blood gases
Measured: immediately after fetal extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start27 Aug 2018
- Primary completion20 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaouther Dimassi, University Tunis El Manar
- Investigators
- kaouther dimassi, MD, Principal investigator, University Tunis El Manar , Faculty of medicine Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741907
- Sponsor's protocol ID
- FAUCS MongiSlim
- Acronym
- MLC
- Status last verified
- Dec 2020
- First submitted
- 5 Nov 2018
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Ambulatory and Misgav Ladach Cesarean Section Techniques : a Results of a Comparative Randomized Trial.
- ClinicalTrials.gov ID
- NCT03741907
- Acronym / sponsor ID
- MLC / FAUCS MongiSlim
- Conditions
- Cesarean Section
- Keywords
- Cesarean, Surgery, Birth, Recovery, Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 15 Nov 2018 (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.
In the last decades cesarean section rates are getting higher in many countries. The rise in those rates encourages obstetricians to improve operative techniques for a better maternal and fetal outcome.
Despite its worldwide spread, a general consensus on the most appropriate technique to use has not yet been reached.
The most known surgical technique is the MLC . A modified extraperitoneal method of caesarean section :" French Ambulatory Cesarean Section ( FAUCS) was described in the middle of the 90's by "Denis Fauck" and "Jacques Henri Ravina " However, no study comparing these two cesarean techniques was conducted. From where the investigators initiate this study .
Detailed description
Caesarean Section (CS) is one of the most commonly performed operations worldwide The rate of CS continues to rise, despite initiatives to counter this trend. Cesarean sections have a higher morbidity rate than vaginal deliveries, with a substantial care and cost measurable by the mean hospital stay, the use of analgesics, and the potential for complications . Crucially, the birth of a new baby is an unique incentive to return quickly to "normal" function. Improving the cesarean section techniques is therefore of considerable importance in modern obstetrics.
One of the most widely used cesarean section techniques is the MLC method developed by Michael Stark et al. This approach is indicated as the optimal technique in view of its characteristic of reducing lower pelvic discomfort and pain, thus improving quality of life However, this intraperitoneal C-section interfere at least with future fertility desire.
The French Ambulatory Cesarean Section (FAUCS) technique has been employed by 10 practitioners in France for approximately 20 years. In a retrospective study over 3000 cases this innovative approach seems to provide a shorter recovery time with a Hospital discharge the day after surgery . Investigators introduced this technique in "Mongi Slim" university hospital in January 2018. In this study, investigators compare the FAUCS and the MLC techniques in termes of mother and child outcomes
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAUCS | Experimental | Procedure: FAUCSFrench Ambulatory C-section |
| MLC | Active comparator | Procedure: MLCGold Standard |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- gestational age of at least 37 weeks of amenorrhea
- indication of elective cesarean delivery mode (breech presentation ; Fetal macrosomia ; Placenta previa)
Key exclusion criteria (3 listed)
- Fetal pathology diagnosed prenatally( intrauterine growth restriction , malformation, genetic pathology ... )
- Morbidity adherent placenta
- emergency Cesarean section
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 |
|---|---|---|
| FAUCSAlso: French Ambulatory Cesarean sectionextraperitoneal cesarean with a paramedian left section | Procedure or surgery | FAUCS |
| MLCAlso: "Misgav Ladach" MethodGold standard | Procedure or surgery | MLC |
Primary outcome
changes in post operative pain
Time frame: 6 hours ; 12 hours , 18 hours , 24 hours
changes in postoperative analgesic requirements, changes in self reported pain using the Visual Analog Scale for Pain (VAS Pain) intensity ( The pain VAS is a single-item scale.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale] )
delay to hospital discharge
Time frame: up to 72 hours
report of total days spent in hospital after surgery
6 secondary outcomes
blood loss
Time frame: the day before surgery and the day after surgery (24 hours)
operation time
Time frame: during the surgery
rate of short term incidents
Time frame: during the surgery and 24 hours after surgery
patient autonomy questionnaire
Time frame: up to 48 hours after surgery
newborn overall condition
Time frame: 5 minutes from birth
neonatal acid base balance
Time frame: immediately after fetal extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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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.
kaouther dimassi, MD principal investigator
University Tunis El Manar , Faculty of medicine Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAUCS and MLC in people with Cesarean Section, run by University Tunis El Manar at 1 site in Tunisia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Dec 2020. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in post operative pain (time frame: 6 hours ; 12 hours , 18 hours , 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.