Appendectomy During Pregnancy and Child Development

Completed

• Conditions: Appendicitis Acute; Child Development; Pregnancy Related; Anesthetic Toxicity; Psychomotor Development Impaired

• Registration Number: NCT05759351
• Lead Sponsor: Clinical Hospital Centre Zagreb

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2022-12-05
• Study First Submitted: 2023-01-01
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-05
• Last Update Submitted: 2023-03-05
• Study First Posted: 2023-03-08
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• all pregnant women operated for acute appendicitis (January 2006- December 2020)

Exclusion Criteria

• pregnant women younger than 18
• nonpregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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 obstetric factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children	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 clinical-laboratory parameters and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children	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	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	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	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.

Trial Locations

Locations (1)

University Hospital Center Zagreb; 🇭🇷 Zagreb, Croatia