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

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 .

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Procedure: FAUCS; Procedure: MLC

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Sidi Daoued La Marsa
    • Tunis, Sidi Daoued La Marsa, Tunisia, 2045
      • Kaouther Dimassi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton pregnancy
• gestational age of at least 37 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAUCS; French Ambulatory C-section	Procedure: FAUCS; extraperitoneal cesarean with a paramedian left section; Other Names: French Ambulatory Cesarean section
Active Comparator: MLC; Gold Standard	Procedure: MLC; Gold standard; Other Names: "Misgav Ladach" Method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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] )	6 hours ; 12 hours , 18 hours , 24 hours
delay to hospital discharge	report of total days spent in hospital after surgery	up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	change in hemoglobin and hematocrit rate	the day before surgery and the day after surgery (24 hours)
operation time	total operation time ; time to fetal extraction ; time to uterine sutures	during the surgery
rate of short term incidents	rate of hemorrhage, rate of transfusion, rate of bladder injury	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	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.)	5 minutes from birth
neonatal acid base balance	Cord blood gases	immediately after fetal extraction

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Principal Investigator: kaouther dimassi, MD, University Tunis El Manar , Faculty of medicine Tunis

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Recovery; Surgery; Outcomes; Cesarean; Birth
• Other Study ID Numbers: FAUCS MongiSlim

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No