Appendicitis AcuteAPPENDECTOMYNCT04876547
Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?
An observational study of Appendicitis Acute and Cesarean Wound Disruption With Postnatal Complication, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
It is not known whether appendectomy for acute appendicitis (AA) increases the Cesarean section (CS) rate and whether CS increases the likelihood of AA and appendectomy in the early puerperium. In this study, delivery type and delivery outcomes and appendectomy during pregnancy and puerperium were analyzed. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appendicitis Acute, Cesarean Wound Disruption With Postnatal Complication
- What is being tested?
- appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 1 Oct 2020
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who attended prenatal follow-up and delivered from October 1, 2015, to October 1, 2020.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
It is not known whether appendectomy for acute appendicitis (AA) increases the Cesarean section (CS) rate and whether CS increases the likelihood of AA and appendectomy in the early puerperium. In this study, delivery type and delivery outcomes and appendectomy during pregnancy and puerperium were analyzed.
Read the detailed description
This cross-sectional retrospective study was performed on 11513 women, delivered during 2015-2020. Inclusion criteria were patients submitted to appendectomy for AA during pregnancy and the first six weeks after delivery. Evaluating parameters were age, parity, gestational week at birth, delivery type, and babies' birth weight.
- Being tested
- appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendectomyProcedure or surgery
appendectomy performance
| Study group | Role | What they receive |
|---|---|---|
| In pregnancy | Appendectomy in pregnancy (n=12) Receives: Procedure: appendectomy | |
| In postpartum | Appendectomy in postpartum first six week (n=20) Receives: Procedure: appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
delivery type
vaginal birth, cesarean section
Measured: 5 years
Secondary outcomes (1)
Newborn weight
kg
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jan 2015
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banuhan, Amasya University
- Investigators
- Banuhan Şahin, Principal investigator, Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876547
- Sponsor's protocol ID
- AmasyaU
- Acronym
- APPENDECTOMY
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?
- ClinicalTrials.gov ID
- NCT04876547
- Acronym / sponsor ID
- APPENDECTOMY / AmasyaU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 6 May 2021 (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.
It is not known whether appendectomy for acute appendicitis (AA) increases the Cesarean section (CS) rate and whether CS increases the likelihood of AA and appendectomy in the early puerperium. In this study, delivery type and delivery outcomes and appendectomy during pregnancy and puerperium were analyzed.
Detailed description
This cross-sectional retrospective study was performed on 11513 women, delivered during 2015-2020. Inclusion criteria were patients submitted to appendectomy for AA during pregnancy and the first six weeks after delivery. Evaluating parameters were age, parity, gestational week at birth, delivery type, and babies' birth weight.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In pregnancy | – | Procedure: appendectomyAppendectomy in pregnancy (n=12) |
| In postpartum | – | Procedure: appendectomyAppendectomy in postpartum first six week (n=20) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who attended prenatal follow-up and delivered from October 1, 2015, to October 1, 2020.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| appendectomyappendectomy performance | Procedure or surgery | In postpartum, In pregnancy |
Primary outcome
delivery type
Time frame: 5 years
vaginal birth, cesarean section
1 secondary outcome
Newborn weight
Time frame: 5 years
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 6 May 2021.
- Individual participant dataSharing planned: No
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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.
Banuhan Şahin principal investigator
Gynecology and Obstetrics
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 Cesarean Wound Disruption With Postnatal Complication, run by Amasya University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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 6 May 2021. 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 Turkey (Türkiye). 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?
delivery type (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.