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临床试验/NCT03928795
NCT03928795已完成不适用

Perinatal Morbidity Factors During Elective Cesarean Section

University Tunis El Manar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
neonatal acid base balance

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • -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.

结局指标

主要结局

neonatal acid base balance

时间窗: immediately after fetal extraction

Cord blood gases

次要结局

  • apgar score(1,3,5 and 10 minutes of life)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaouther Dimassi

associate professor in obstetrics and gynecoloy

University Tunis El Manar

研究点 (1)

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