Appendectomy During Pregnancy in General Anesthesia With Perioperative Management Does Not Influence Normal Child Development: 10-year Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Impact of obstetric factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children
研究概览
简要总结
Maternal acute appendicitis during pregnancy is the most common abdominal surgical emergency. Long-term neurodevelopmental issues were scarcely reported. The aim of the study is to investigate the impact of appendicitis and appendectomy during pregnancy in general anesthesia on the cognitive and psychomotor development of children.
详细描述
Maternal acute appendicitis (AA) is the most common emergent abdominal surgical condition during pregnancy. Brain development in a fetus is dynamic and complex, and therefore much more vulnerable to different agents. Gastrointestinal operations during pregnancy are performed in general anesthesia and anesthetic neurotoxicity in the developing brain, through the period from a fetus to a child, delivered inconsistent results.
Child development after AA or other intra-abdominal inflammatory/infective condition during pregnancy was not consistently reported or studied. In most reports, the length of fetal follow-up after appendectomy for AA during pregnancy is not defined, not stated, or declared as 'uneventful'.
Investigators will make a study with a structured children's cognitive and neurodevelopmental follow-up whose mothers had operated acute appendicitis during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all pregnant women operated for acute appendicitis (January 2006- December 2020)
排除标准
- •pregnant women younger than 18
- •nonpregnant women
结局指标
主要结局
Impact of obstetric factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children
时间窗: January 2006 to December 2020
Analyzed data will include obstetric factors- age at delivery, gestational week of delivery, delivery route, elective or emergent delivery, tocolysis, neonatal height, neonatal weight, APGAR score, complications during pregnancy, infections or pyrexias, congenital malformations)
Impact of maternal sociodemographic characteristics and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children
时间窗: January 2006 to December 2020
Analyzed data will include maternal sociodemographic characteristics- chronic diseases, psychiatric diseases, childhood disease, level of education, level of partner's education, working status, marital status, city or rural living, GPA (gravida, para, abortus) status, number of household persons
Impact of clinical-laboratory parameters and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children
时间窗: January 2006 to December 2020
Analyzed data will include clinical-laboratory parameters- differential blood count, C-reactive protein, platelets, axillary temperature, transabdominal ultrasound, Alvarado score, Tzanakis score)
Impact of surgical factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children
时间窗: January 2006 to December 2020
Analyzed data will include surgical factors- open or laparoscopic appendectomy, type, and duration of antibiotic therapy, degree of appendiceal inflammation
Impact of anesthesiologic factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children
时间窗: January 2006 to December 2020
Analyzed data will include anesthesiologic parameters- type and duration of anesthesia, anesthetics and analgesics used, maternal behavior and emotional status during pregnancy (presence and extent of stressful events, alcohol, medication, and/or drugs consumption, smoking, maternal nutrition and diet)
Impact of pediatric factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children
时间窗: January 2006 to December 2020
Analyzed data will include pediatric parameters (child's growth and development, existence of congenital malformations, childhood diseases, medical conditions and procedures, need for surgical treatments, routine pediatric checkups, physical or speech therapy, referrals to specialists, early separations, exposure to highly stressful or traumatic events, and academic success for older children) A psychiatry resident will led the interviews using a structured questionnaire for mothers designed for this study during interviews. Based on the parents' observations and assessment and available medical data, the child's psychomotor and cognitive development and medical status will be analyzed during a clinical interview with the mother.
次要结局
未报告次要终点
研究者
Branko Bogdanic
MD, PhD
Clinical Hospital Centre Zagreb