Are Cesarean Section and Appendectomy in Pregnancy and Pu... | NCT04876547

Studies
Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?

NCT04876547

Sponsor

Amasya University

Status

Completed

Last Update Posted

May 6, 2021Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Appendicitis Acute
Cesarean Wound Disruption With Postnatal Complication

Interventions

appendectomy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Oct 1, 2020Actual

Completion Date

Oct 1, 2020Actual

First Submitted Date

May 3, 2021

First Submission Date that Met QC Criteria

May 3, 2021

First Posted Date

May 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2021

Last Update Posted Date

May 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
In pregnancy		Appendectomy in pregnancy (n=12)	Procedure: appendectomy
In postpartum		Appendectomy in postpartum first six week (n=20)	Procedure: appendectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
appendectomy	Procedure	appendectomy performance	In postpartum In pregnancy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Newborn weight	kg	5 years

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnancy

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Banuhan Şahin	Gynecology and Obstetrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banuhan Şahin		Amasya			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001062	Appendectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided