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Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques (MLC)

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ClinicalTrials.gov Identifier: NCT03741907
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Kaouther Dimassi, University Tunis El Manar

Brief 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.

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 .


Condition or disease Intervention/treatment Phase
Cesarean Section Procedure: FAUCS Procedure: MLC Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: French Ambulatory and Misgav Ladach Cesarean Section Techniques : a Results of a Comparative Randomized Trial.
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: FAUCS
French Ambulatory C-section
Procedure: FAUCS
extraperitoneal cesarean with a paramedian left section
Other Name: French Ambulatory Cesarean section

Active Comparator: MLC
Gold Standard
Procedure: MLC
Gold standard
Other Name: "Misgav Ladach" Method




Primary Outcome Measures :
  1. 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] )

  2. delay to hospital discharge [ Time Frame: up to 72 hours ]
    report of total days spent in hospital after surgery


Secondary Outcome Measures :
  1. blood loss [ Time Frame: the day before surgery and the day after surgery (24 hours) ]
    change in hemoglobin and hematocrit rate

  2. operation time [ Time Frame: during the surgery ]
    total operation time ; time to fetal extraction ; time to uterine sutures

  3. rate of short term incidents [ Time Frame: during the surgery and 24 hours after surgery ]
    rate of hemorrhage, rate of transfusion, rate of bladder injury

  4. patient autonomy questionnaire [ Time Frame: up to 48 hours after surgery ]
    time to first spontaneous miction, time to stand up ; time to first complete meal, time to first breastfeeding

  5. newborn overall condition [ Time Frame: 5 minutes from birth ]
    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.)

  6. neonatal acid base balance [ Time Frame: immediately after fetal extraction ]
    Cord blood gases



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • gestational age of at least 36 weeks of amenorrhea
  • indication of elective cesarean delivery mode (breech presentation ; Fetal macrosomia ; Placenta previa)

Exclusion Criteria:

  • Fetal pathology diagnosed prenatally( intrauterine growth restriction , malformation, genetic pathology ... )
  • Morbidity adherent placenta
  • emergency Cesarean section

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741907


Locations
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Tunisia
Kaouther Dimassi
Tunis, Sidi Daoued La Marsa, Tunisia, 2045
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Principal Investigator: kaouther dimassi, MD University Tunis El Manar , Faculty of medicine Tunis
  Study Documents (Full-Text)

Documents provided by Kaouther Dimassi, University Tunis El Manar:

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Responsible Party: Kaouther Dimassi, Associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03741907     History of Changes
Other Study ID Numbers: FAUCS MongiSlim
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaouther Dimassi, University Tunis El Manar:
Cesarean
Surgery
Birth
Recovery
Outcomes