Appendicitis AcuteNCT05759351
Appendectomy During Pregnancy and Child Development
An observational study of Appendicitis Acute and Pregnancy Related, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Appendicitis Acute, Pregnancy Related, Anesthetic Toxicity
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2006to 5 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All pregnant women operated for acute appendicitis at the University Hospital Center Zagreb, Croatia, January 2006- December 2020.
Who may be able to join
- all pregnant women operated for acute appendicitis (January 2006- December 2020)
Who cannot join
- pregnant women younger than 18
- nonpregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appendectomy During Pregnancy in General Anesthesia With Perioperative Management Does Not Influence Normal Child Development: 10-year Study
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.
Read the 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.
- Conditions
- Appendicitis Acute, Pregnancy Related, Anesthetic Toxicity, Child Development, Psychomotor Development Impaired
- Keywords
- appendicitis, pregnancy, child development, psychomotor development impaired
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: January 2006 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Jan 2006
- Primary completion31 Dec 2020
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Branko Bogdanic, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759351
- Sponsor's protocol ID
- 202201
- Status last verified
- Mar 2023
- First submitted
- 1 Jan 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34898628Yu 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.
PubMed 30477448Choi 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.
PubMed 21856183Kocael 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.
PubMed 25952362Hannan 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.
PubMed 22311138Rizzo 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.
PubMed 12676015Al-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.
PubMed 30840048de 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.
PubMed 23913654Sumilo 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.
PubMed 35580876Lapin 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.
PubMed 25532738Tomar 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.
PubMed 34192823Cho 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.
PubMed 34313034Shigemi 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.
PubMed 29909089Bleeser 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.
PubMed 33631746Augustin 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.
PubMed 32556754
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appendectomy During Pregnancy in General Anesthesia With Perioperative Management Does Not Influence Normal Child Development: 10-year Study
- ClinicalTrials.gov ID
- NCT05759351
- Acronym / sponsor ID
- 202201
- Conditions
- Appendicitis Acute, Pregnancy Related, Anesthetic Toxicity, Child Development, Psychomotor Development Impaired
- Keywords
- appendicitis, pregnancy, child development, psychomotor development impaired
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women operated for acute appendicitis at the University Hospital Center Zagreb, Croatia, January 2006- December 2020.
Key inclusion criteria (1 listed)
- all pregnant women operated for acute appendicitis (January 2006- December 2020)
Key exclusion criteria (2 listed)
- pregnant women younger than 18
- nonpregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Background: PubMed 34898628Yang 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.
- Background: PubMed 30477448Yu 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.
- Background: PubMed 21856183Choi 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.
- Background: PubMed 25952362Kocael 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.
- Background: PubMed 22311138Hannan 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.
- Background: PubMed 12676015Rizzo 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.
- Background: PubMed 30840048Al-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.
- Background: PubMed 23913654de 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.
- Background: PubMed 35580876Sumilo 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.
- Background: PubMed 25532738Lapin 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.
- Background: PubMed 34192823Tomar 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.
- Background: PubMed 34313034Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute and Pregnancy Related, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: January 2006 to December 2020). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05759351, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.