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Perinatal Morbidity Factors During Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03928795
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Kaouther Dimassi, University Tunis El Manar

Brief Summary:

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:

  • Modifiable factors: surgical technique, anesthesia technique, operator experience, operative time
  • Not modifiable factors: characteristics inherent to the mother: BMI, gravidic pathology, number of caesareans...

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


Condition or disease Intervention/treatment
Perinatal Morbidity Procedure: elective caesarean section

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Perinatal Morbidity Factors During Elective Cesarean Section
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort Intervention/treatment
neonates with acute acidosis Procedure: elective caesarean section
elective caesarean section

neonates with a normal ph Procedure: elective caesarean section
elective caesarean section




Primary Outcome Measures :
  1. neonatal acid base balance [ Time Frame: immediately after fetal extraction ]
    Cord blood gases


Secondary Outcome Measures :
  1. apgar score [ Time Frame: 1,3,5 and 10 minutes of life ]
    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.


Other Outcome Measures:
  1. neonatal transfer to neonatal intensive care unit [ Time Frame: during the first day ]
    hospitalisation in intensive care unit



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Was defined by all women with indication of an elective caesarean section in our department during the study period.
Criteria

Inclusion Criteria:

  • Monofetal pregnancy
  • Age over 18 years old
  • Term Pregnancy ≥ 37SA
  • Indication for Elective caesarean section

Exclusion Criteria:

  • -Fetal pathology known prenatally like intrauterine severe growth retardation with Doppler abnormalities, fetal malformation or a known fetal genetic defect.
  • Anomaly of placental adhesion.
  • Caesarean in a context of medical or obstetric emergency.
  • Caesarean section performed under general anesthesia following failure of locoregional anesthesia.
  • Refusal of the woman to participate in the study.
  • Impossibility or failure to study the neonatal acid-base balance on the umbilical cord.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928795


Locations
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Tunisia
Kaouther Dimassi
Tunis, Sidi Daoued La Marsa, Tunisia, 2045
Sponsors and Collaborators
University Tunis El Manar

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Responsible Party: Kaouther Dimassi, associate professor in obstetrics and gynecoloy, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03928795     History of Changes
Other Study ID Numbers: perinatal morbidity mongi slim
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaouther Dimassi, University Tunis El Manar:
neonatal ph
neonatal eucapnic ph
fetal extraction
elective caesarean
apgar score