Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques

NCT ID: NCT03741907

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2019-04-30

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 .

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

Keywords

Cesarean; Surgery; Birth; Recovery; Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

FAUCS

French Ambulatory C-section

Group Type: EXPERIMENTAL

FAUCS

Intervention Type: PROCEDURE

extraperitoneal cesarean with a paramedian left section

MLC

Gold Standard

Group Type: ACTIVE_COMPARATOR

MLC

Intervention Type: PROCEDURE

Gold standard

Interventions

FAUCS

extraperitoneal cesarean with a paramedian left section

Intervention Type: PROCEDURE

MLC

Gold standard

Intervention Type: PROCEDURE

Other Intervention Names

French Ambulatory Cesarean section; "Misgav Ladach" Method

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Kaouther Dimassi

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kaouther dimassi, MD

Role: PRINCIPAL_INVESTIGATOR

University Tunis El Manar , Faculty of medicine Tunis

Locations

Kaouther Dimassi

Tunis, Sidi Daoued La Marsa, Tunisia

Countries

Tunisia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FAUCS MongiSlim

Identifier Type: -

Identifier Source: org_study_id