NCT04876547

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

5.8 years

First QC Date

May 3, 2021

Last Update Submit

May 3, 2021

Conditions

Appendicitis AcuteCesarean Wound Disruption With Postnatal Complication

Outcome Measures

Primary Outcomes (1)

  • delivery type

    vaginal birth, cesarean section

    5 years

Secondary Outcomes (1)

  • Newborn weight

    5 years

Other Outcomes (1)

  • Cesarean indications

    5 years

Study Arms (2)

In pregnancy

Appendectomy in pregnancy (n=12)

Procedure: appendectomy

In postpartum

Appendectomy in postpartum first six week (n=20)

Procedure: appendectomy

Interventions

appendectomyPROCEDURE

appendectomy performance

In postpartumIn pregnancy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banuhan Şahin

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Banuhan Şahin

    Gynecology and Obstetrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 6, 2021

Study Start

January 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)