Perinatal Morbidity Factors During Cesarean Section

NCT03928795 | Completed

• 1 other identifier: perinatal morbidity mongi slim
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Perinatal Morbidity

Keywords

neonatal ph; neonatal eucapnic ph; fetal extraction; elective caesarean; apgar score

Outcome Measures

Primary Outcomes (1)

• neonatal acid base balance

  Cord blood gases

  immediately after fetal extraction

Secondary Outcomes (1)

• apgar score

  1,3,5 and 10 minutes of life

Other Outcomes (1)

• neonatal transfer to neonatal intensive care unit

  during the first day

Study Arms (2)

neonates with acute acidosis

neonates with Cord blood gases measured immediately after birth inferior to 7.15

Procedure: elective caesarean section

neonates with a normal ph

neonates with Cord blood gases measured immediately after birth of at least 7.15

Procedure: elective caesarean section

Interventions

elective caesarean section PROCEDURE

elective caesarean section

neonates with a normal ph; neonates with acute acidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Kaouther Dimassi

Tunis, Sidi Daoued La Marsa, 2045, Tunisia

Location

Study Officials

• kaouther simassi, MD

  university tunis el manar , faculty of medicine Tunis, TUNISIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor in obstetrics and gynecoloy

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 26, 2019
• Study Start: August 27, 2018
• Primary Completion: February 1, 2019
• Study Completion: April 10, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

TU (1)