Comparison of FAUCS vs. Misgav Ladach
Comparison Between French Ambulatory Cesarean Section to The Misgav-Ladach Technique - Double Blind Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such comparison has not been done so far, and this study will examined if indeed the FAUCS techniques offers any advantages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2018
CompletedFirst Submitted
Initial submission to the registry
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedJanuary 23, 2019
December 1, 2018
1 year
December 19, 2018
January 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite maternal adverse outcome
The rate of women with a composite maternal adverse outcome, defined as at least one of the following: Visual Analogue Scale score \>6 (scale of 1-10, 1 being a very mild pain, 10 being the worst pain imagineable) at 3-4 hours post surgery, inability to ambulate 3-4 hours post surgery, and QoR15 (Quality of Recovery) score \< 90 (range 0 to 150, 150 being the best recovery after surgery) at 24 hours post surgery
24 hours post surgery
Secondary Outcomes (5)
Length of surgery
24 hours
Blood loss (ml) during surgery
24 hours
Birthweight
immediately after birth
Cord pH
immediately after birth
Birth trauma
24 hours
Study Arms (2)
FAUCS
EXPERIMENTALPatients undergoing a cesarean section using the FAUCS technique
Control
ACTIVE COMPARATORPatients undergoing a cesarean section using the traditional (Misgav-Ladach) technique
Interventions
A cesarean section performed according to the FAUCS technique
Eligibility Criteria
You may qualify if:
- patients scheduled for a cesarean section
- term pregnancy: 37-42 weeks
- singleton pregnancy
- age 18 and above
- patients capable of signing an informed consent
You may not qualify if:
- multiple pregnancy
- emergency cesarean
- previous 3 cesareans and above
- placenta accreta
- uterine myomas in the lower segment
- fetal growth restriction
- fetal anemia
- preeclampsia
- women scheduled for general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bnai-Zion Medical Center
Haifa, Israel
Related Publications (1)
Sagi S, Bleicher I, Bakhous R, Pelts A, Talhamy S, Caspin O, Sammour R, Sagi-Dain L. Comparison between the modified French AmbUlatory Cesarean Section and standard cesarean technique-a randomized double-blind controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100910. doi: 10.1016/j.ajogmf.2023.100910. Epub 2023 Feb 23.
PMID: 36828283DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2018
First Posted
January 23, 2019
Study Start
August 19, 2018
Primary Completion
August 19, 2019
Study Completion
September 19, 2019
Last Updated
January 23, 2019
Record last verified: 2018-12