Comparing French Ambulatory and MISGAV-LADACH C-Section Techniques

NCT03741907 | Completed

• 1 other identifier: FAUCS MongiSlim
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Cesarean Section

Keywords

Cesarean; Surgery; Birth; Recovery; Outcomes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• blood loss

  the day before surgery and the day after surgery (24 hours)

• operation time

  during the surgery

• rate of short term incidents

  during the surgery and 24 hours after surgery

• patient autonomy questionnaire

  up to 48 hours after surgery

• newborn overall condition

  5 minutes from birth

Study Arms (2)

FAUCS

EXPERIMENTAL

French Ambulatory C-section

Procedure: FAUCS

MLC

ACTIVE COMPARATOR

Gold Standard

Procedure: MLC

Interventions

FAUCS PROCEDURE

extraperitoneal cesarean with a paramedian left section

Also known as: French Ambulatory Cesarean section

FAUCS

MLC PROCEDURE

Gold standard

Also known as: "Misgav Ladach" Method

MLC

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• gestational age of at least 37 weeks of amenorrhea
• indication of elective cesarean delivery mode (breech presentation ; Fetal macrosomia ; Placenta previa)

You may not qualify if:

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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Kaouther Dimassi

Tunis, Sidi Daoued La Marsa, 2045, Tunisia

Location

Study Officials

• kaouther dimassi, MD

  University Tunis El Manar , Faculty of medicine Tunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 15, 2018
• Study Start: August 27, 2018
• Primary Completion: March 20, 2019
• Study Completion: April 30, 2019
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)