Training Clinical Trial
Official title:
Learning Curve of the "French Ambulatory Caesarean Section"
NCT number | NCT04155177 |
Other study ID # | 36211361 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | March 30, 2021 |
Est. completion date | March 30, 2022 |
Verified date | April 2021 |
Source | University Tunis El Manar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In the last decades, caesarean section (CS) rates are getting higher in all over the world. This encourages us to improve operative techniques. In January 2018, investigators have introduced in the study unit: The French Ambulatory C section (FAUCS). This innovative approach appeares to provide a shorter recovery time, with a hospital discharge the day after surgery in 90% and then a better experience of childbirth. The diffusion of this technique requires its integration to the curriculum of residency. In this study, investigators will determine the mean number of procedures needed for trainees to master FAUCS.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 30, 2022 |
Est. primary completion date | January 3, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - trainee in obstetrics and gynecology. - trainee subscribed for a training programm in the suty unit during the study period Exclusion Criteria : - Trainee in obstetrics and gynecology subscribed in atraining program elswhere from the sutudy unit during the study period - trainee who refused to participate in the study |
Country | Name | City | State |
---|---|---|---|
Tunisia | Kaouther Dimassi | Tunis | Marsa |
Lead Sponsor | Collaborator |
---|---|
University Tunis El Manar |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of surgical procedure needed for a trainee to master the FAUCS. | Number of surgical procedure needed for a trainee to acheive the highest evaluation | through study completion, an average of 1 year | |
Secondary | operative time | time elapsed from skin incision and the end of surgery will be measured in minutes | through study completion, an average of 1 year | |
Secondary | neonatal acid base balance | cord blood gaz | immediately after birth | |
Secondary | new born 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 after birth | |
Secondary | calculated blood loss | changes in hematocrites levels before and after a surgery | the day and 24 hours after surgery |
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