Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated? (APPENDECTOMY)

May 3, 2021 updated by: Banuhan, Amasya University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Amasya, Turkey
        • Banuhan Şahin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who attended prenatal follow-up and delivered from October 1, 2015, to October 1, 2020.

Description

Inclusion Criteria: Women aged 18-45 years submitted to appendectomy for acute appendicitis during pregnancy or within the first six weeks after delivery were included.

-

Exclusion Criteria: Cases with missing data were excluded.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
In pregnancy
Appendectomy in pregnancy (n=12)
Procedure: appendectomy
appendectomy performance
In postpartum
Appendectomy in postpartum first six week (n=20)
Procedure: appendectomy
appendectomy performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delivery type
Time Frame: 5 years
vaginal birth, cesarean section
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newborn weight
Time Frame: 5 years
kg
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean indications
Time Frame: 5 years
Fetal distress, dystocia, breech position
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amasya University

Investigators

  • Principal Investigator: Banuhan Şahin, Gynecology and Obstetrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AmasyaU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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