Myomectomy During Cesarean Section | NCT03095014

Studies
Myomectomy During Cesarean Section

NCT03095014

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Mar 29, 2017Actual

Enrollment

76Actual

Phase

Phase 1

Conditions

Myomectomy

Interventions

Cesarean Myomectomy
Cesarean section

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

Mar 2017

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 2010Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Oct 2016Actual

First Submitted Date

Mar 16, 2017

First Submission Date that Met QC Criteria

Mar 22, 2017

First Posted Date

Mar 29, 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

Mar 22, 2017

Last Update Posted Date

Mar 29, 2017Actual

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

Cesarean Myomectomy, safety and effect on uterine cavity.

Detailed Description

this study aims to compare between women who underwent Cesarean Myomectomy and those who underwent Cesarean section only regarding the procedure safety and whether uterine cavity was affected later on.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cesarean Myomectomy	Experimental	Myomectomy plus Cesarean section	Procedure: Cesarean Myomectomy
Cesarean section	Active Comparator	Cesarean section only	Procedure: Cesarean section

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cesarean Myomectomy	Procedure	Myomectomy was done during Cesarean section	Cesarean Myomectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change in Haemoglobin in gm/dl	pre-operative Haemoglobin minus post-operative Haemoglobin level	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Duration of operation in hours	time to complete the procedure	2 hours
intrauterine adesion adhesions	presence of uterine cavity adhesions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant
full term
had uterine myoma

Exclusion Criteria:

history of coagulation disorder
antepartum hemorrhage
previous myomectomy
where additional operative procedures were performed

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ibrahim A el sharkwy	Zagazig University	Principal Investigator

Locations

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D002585	Cesarean Section

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

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