Myomectomy During CS: A Retrospective Cohort Study | NCT03270605

Studies
Myomectomy During CS: A Retrospective Cohort Study

NCT03270605

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Sep 1, 2020Actual

Enrollment

178Actual

Phase

Not provided

Conditions

Cesarean Section
Uterine Fibroid

Interventions

Myomectomy

Countries

Not provided

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

Aug 2020

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

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Aug 31, 2017

First Submission Date that Met QC Criteria

Aug 31, 2017

First Posted Date

Sep 1, 2017Actual

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

Aug 28, 2020

Last Update Posted Date

Sep 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.

Detailed Description

Not provided

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

178Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CS with myomectomy		Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS	Procedure: Myomectomy
CS without myomectomy		Women having uterine myoma with pregnancy and delivered by CS without myomectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myomectomy	Procedure	Surgical removal of uterine fibroid	CS with myomectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Deficit in hemoglobin level	Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Operative time	Time to complete the procedure	3 hours
Postoperative hospital stay period	Time from the end of operation to discharge from hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery

Exclusion Criteria:

Antepartum hemorrhage
Blood diseases or bleeding tendencies.
Medical conditions complicating pregnancy.
Performed another surgical procedure at CS other than myomectomy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

41 Years

Standard Ages

Adult

Study Population

Pregnant women with uterine fibroid during the index pregnancy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Waleed El-refaie, MD	Port Said University	Principal Investigator
Mohamed Hassan, MD	Mansoura University	Study Director
Mohamed S Abdelhafez, MD	Mansoura University	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063186	Uterine Myomectomy

Ancestor Terms

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided