An observational study in Perinatal Morbidity, sponsored by University Tunis El Manar. Completed at 1 site in Tunisia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by University Tunis El Manar · Observational
Caesarean section is one of the most common surgeries in the world and the increasing rate of cesarean delivery is associated with increased maternal and fetal morbidity when compared to vaginal delivery.
With this dramatic increase in caesarean section rates, it is urgent to identify factors that may affect perinatal morbidity. Indeed, such factors can be classified into:
Majority of previous studies focused on anesthetic factors. A global vision integrating all parameters is necessary in order to best guide the preventative measures to be put in place.
our Objectives were : To Identify and to Analyze Perinatal Morbidity Factors During Caesarean Section
I- Characteristics of the study:
Non-interventional descriptive longitudinal prospective study.
II- Location and period of study:
The study tooked place in the obstetrics and gynecology department of the Mongi Slim La Marsa University Hospital from 27 august 2018 until 10.04.2019.
III- The study population:
Was defined by all women with indication of an elective caesarean section in our department during the study period.
IV-The eligibility criteria:
The inclusion criteria:
The non-inclusion criteria:
Exclusion criteria:
V-Investigators:
The resident responsible for the study :
He was responsible for the inclusion and collection of preoperative and postoperative data.
They immediately after surgery reported on the patient information sheet the surgical features of the cesarean section: the technique used, the methods of fetal extraction, the difficulties encountered...
VI- The judgment criteria:
VII-The progress of the study:
The pre-inclusion visit
All the patients followed at the outpatient clinic were informed of the study during the prenatal visit of the 8th month.
The resident responsible for the study checked the eligibility criteria and informed the patient of the research objectives, its progress and the expected benefits of the research.
He answered all questions about Cesarean the study. A period of reflection until the day of delivery was left for signing the consent form. (see annexes 1 and 2)
The inclusion visit The resident in charge of the study was responsible for the final verification of the eligibility criteria and obtaining the written informed consent of the patient in Arabic (Appendix 1) and in French (Appendix 2).
If the patient agreed to participate, the investigator wrote his name and surname in clear, date and sign the consent form.
The patients recruited were chronologically assigned a number until the end of the study.
Thus, the indication of cesarean delivery and the date of the operation were not affected by the inclusion of the patient in this observational study.
Investigators described the anesthetic and surgical techniques. Thus, the patient file was completed prospectively and specified the items relating to
The rank of the operator and his experience in caesarean surgery.
-Caesarean technique: Indeed, two caesarean techniques are used in our department and the choice between the two was attributed to the operator.
VIII-Statistic study:
We performed a correlation Pearson study between the different operating times measured during the study and the value of the neonatal eucapnic PH.
We performed a logistic regression to identify among the used variables the factors that significantly and independently influenced the neonatal outcome. We identified two major events : neonatal ph\<7.15 and neonatal ph \<7.1
University Tunis El Manar is the lead sponsor of 73 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Was defined by all women with indication of an elective caesarean section in our department during the study period.
Exclusion Criteria:
neonates with Cord blood gases measured immediately after birth inferior to 7.15
Procedure: elective caesarean section
neonates with Cord blood gases measured immediately after birth of at least 7.15
Procedure: elective caesarean section
elective caesarean section
neonatal acid base balance
Cord blood gases
Time frame: immediately after fetal extraction
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.
Time frame: 1,3,5 and 10 minutes of life
neonatal transfer to neonatal intensive care unit
hospitalisation in intensive care unit
Time frame: during the first day
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University Tunis El Manar