Appendectomy During Pregnancy and Child Development

NCT05759351 | Completed

• 1 other identifier: 202201
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Acute; Pregnancy Related; Anesthetic Toxicity; Child Development; Psychomotor Development Impaired

Keywords

appendicitis, pregnancy, child development, psychomotor development impaired

Outcome Measures

Primary Outcomes (6)

• 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

  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

  January 2006 to December 2020

• Impact of obstetric factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children

  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)

  January 2006 to December 2020

• 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

  Analyzed data will include clinical-laboratory parameters- differential blood count, C-reactive protein, platelets, axillary temperature, transabdominal ultrasound, Alvarado score, Tzanakis score)

  January 2006 to December 2020

• Impact of surgical factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children

  Analyzed data will include surgical factors- open or laparoscopic appendectomy, type, and duration of antibiotic therapy, degree of appendiceal inflammation

  January 2006 to December 2020

• Impact of anesthesiologic factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children

  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)

  January 2006 to December 2020

• Impact of pediatric factors and inflammation of the appendix and appendectomy during pregnancy under general anesthesia on the cognitive and psychomotor development of children

  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.

  January 2006 to December 2020

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women operated for acute appendicitis at the University Hospital Center Zagreb, Croatia, January 2006- December 2020.

You may qualify if:

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

You may not qualify if:

• pregnant women younger than 18
• nonpregnant women

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University Hospital Center Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (23)

• Yang J, Wen SW, Krewski D, Corsi DJ, Walker M, Mattison D, Moog R, McNair D, Huang H, Zhuang G. Association of treatments for acute appendicitis with pregnancy outcomes in the United States from 2000 to 2016: Results from a multi-level analysis. PLoS One. 2021 Dec 13;16(12):e0260991. doi: 10.1371/journal.pone.0260991. eCollection 2021.

  PMID: 34898628 BACKGROUND

• Yu CH, Weng SF, Ho CH, Chen YC, Chen JY, Chang YJ, Wang JJ, Wu MP, Chu CC. Pregnancy outcomes following nonobstetric surgery during gestation: a nationwide population-based case-control study in Taiwan. BMC Pregnancy Childbirth. 2018 Nov 26;18(1):460. doi: 10.1186/s12884-018-2079-4.

  PMID: 30477448 BACKGROUND

• Choi JJ, Mustafa R, Lynn ET, Divino CM. Appendectomy during pregnancy: follow-up of progeny. J Am Coll Surg. 2011 Nov;213(5):627-32. doi: 10.1016/j.jamcollsurg.2011.07.016. Epub 2011 Aug 19.

  PMID: 21856183 BACKGROUND

• Kocael PC, Simsek O, Saribeyoglu K, Pekmezci S, Goksoy E. Laparoscopic surgery in pregnant patients with acute abdomen. Ann Ital Chir. 2015 Mar-Apr;86(2):137-42.

  PMID: 25952362 BACKGROUND

• Hannan MJ, Hoque MM, Begum LN. Laparoscopic appendectomy in pregnant women: experience in Chittagong, Bangladesh. World J Surg. 2012 Apr;36(4):767-70. doi: 10.1007/s00268-012-1445-z.

  PMID: 22311138 BACKGROUND

• Rizzo AG. Laparoscopic surgery in pregnancy: long-term follow-up. J Laparoendosc Adv Surg Tech A. 2003 Feb;13(1):11-5. doi: 10.1089/109264203321235403.

  PMID: 12676015 BACKGROUND

• Al-Haddad BJS, Jacobsson B, Chabra S, Modzelewska D, Olson EM, Bernier R, Enquobahrie DA, Hagberg H, Ostling S, Rajagopal L, Adams Waldorf KM, Sengpiel V. Long-term Risk of Neuropsychiatric Disease After Exposure to Infection In Utero. JAMA Psychiatry. 2019 Jun 1;76(6):594-602. doi: 10.1001/jamapsychiatry.2019.0029.

  PMID: 30840048 BACKGROUND

• de Jonge L, Bos HJ, van Langen IM, de Jong-van den Berg LT, Bakker MK. Antibiotics prescribed before, during and after pregnancy in the Netherlands: a drug utilization study. Pharmacoepidemiol Drug Saf. 2014 Jan;23(1):60-8. doi: 10.1002/pds.3492. Epub 2013 Aug 3.

  PMID: 23913654 BACKGROUND

• Sumilo D, Nirantharakumar K, Willis BH, Rudge GM, Martin J, Gokhale K, Thayakaran R, Adderley NJ, Chandan JS, Okoth K, Harris IM, Hewston R, Skrybant M, Deeks JJ, Brocklehurst P. Long term impact of prophylactic antibiotic use before incision versus after cord clamping on children born by caesarean section: longitudinal study of UK electronic health records. BMJ. 2022 May 17;377:e069704. doi: 10.1136/bmj-2021-069704.

  PMID: 35580876 BACKGROUND

• Lapin B, Piorkowski J, Ownby D, Freels S, Chavez N, Hernandez E, Wagner-Cassanova C, Pelzel D, Vergara C, Persky V. Relationship between prenatal antibiotic use and asthma in at-risk children. Ann Allergy Asthma Immunol. 2015 Mar;114(3):203-7. doi: 10.1016/j.anai.2014.11.014. Epub 2014 Dec 19.

  PMID: 25532738 BACKGROUND

• Tomar N, Uldbjerg CS, Bech BH, Burgner DP, Pedersen LH, Miller JE. Prenatal antibiotic exposure and birth weight. Pediatr Obes. 2022 Feb;17(2):e12831. doi: 10.1111/ijpo.12831. Epub 2021 Jun 30.

  PMID: 34192823 BACKGROUND

• Cho HW, Cho GJ, Noh E, Hong JH, Kim M, Lee JK. Pregnancy Outcomes Following Laparoscopic and Open Surgery in Pelvis during Pregnancy: a Nationwide Population-based Study in Korea. J Korean Med Sci. 2021 Jul 26;36(29):e192. doi: 10.3346/jkms.2021.36.e192.

  PMID: 34313034 BACKGROUND

• Shigemi D, Aso S, Matsui H, Fushimi K, Yasunaga H. Safety of Laparoscopic Surgery for Benign Diseases during Pregnancy: A Nationwide Retrospective Cohort Study. J Minim Invasive Gynecol. 2019 Mar-Apr;26(3):501-506. doi: 10.1016/j.jmig.2018.06.008. Epub 2018 Aug 2.

  PMID: 29909089 BACKGROUND

• Bleeser T, Van Der Veeken L, Devroe S, Vergote S, Emam D, van der Merwe J, Ghijsens E, Joyeux L, Basurto D, Van de Velde M, Deprest J, Rex S. Effects of Maternal Abdominal Surgery on Fetal Brain Development in the Rabbit Model. Fetal Diagn Ther. 2021;48(3):189-200. doi: 10.1159/000512489. Epub 2021 Feb 25.

  PMID: 33631746 BACKGROUND

• Augustin G, Boric M, Barcot O, Puljak L. Discordant outcomes of laparoscopic versus open appendectomy for suspected appendicitis during pregnancy in published meta-analyses: an overview of systematic reviews. Surg Endosc. 2020 Oct;34(10):4245-4256. doi: 10.1007/s00464-020-07674-6. Epub 2020 Jun 16.

  PMID: 32556754 BACKGROUND

• Tekin A, Evruke C, Deveci O. Maternal and fetal near-term sheep cytokine responses to carbon dioxide pneumoperitoneum. Surg Laparosc Endosc Percutan Tech. 2009 Apr;19(2):138-41. doi: 10.1097/SLE.0b013e31819756bf.

  PMID: 19390281 BACKGROUND

• de la Fuente SG, Pinheiro J, Gupta M, Eubanks WS, Reynolds JD. Early postnatal behavior deficits after maternal carbon dioxide pneumoperitoneum during pregnancy. Surg Endosc. 2003 Nov;17(11):1823-5. doi: 10.1007/s00464-002-8871-1. Epub 2003 Jun 17.

  PMID: 12802645 BACKGROUND

• Andropoulos DB. Effect of Anesthesia on the Developing Brain: Infant and Fetus. Fetal Diagn Ther. 2018;43(1):1-11. doi: 10.1159/000475928. Epub 2017 Jun 7.

  PMID: 28586779 BACKGROUND

• Bleeser T, Van Der Veeken L, Fieuws S, Devroe S, Van de Velde M, Deprest J, Rex S. Effects of general anaesthesia during pregnancy on neurocognitive development of the fetus: a systematic review and meta-analysis. Br J Anaesth. 2021 Jun;126(6):1128-1140. doi: 10.1016/j.bja.2021.02.026. Epub 2021 Apr 6.

  PMID: 33836853 BACKGROUND

• Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.

  PMID: 27272582 BACKGROUND

• Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4.

  PMID: 26507180 BACKGROUND

• Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.

  PMID: 12574416 BACKGROUND

• Walkden GJ, Gill H, Davies NM, Peters AE, Wright I, Pickering AE. Early Childhood General Anesthesia and Neurodevelopmental Outcomes in the Avon Longitudinal Study of Parents and Children Birth Cohort. Anesthesiology. 2020 Nov 1;133(5):1007-1020. doi: 10.1097/ALN.0000000000003522.

  PMID: 32898216 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: March 8, 2023
• Study Start: January 1, 2006
• Primary Completion: December 31, 2020
• Study Completion: December 5, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

CR (1)