Myomectomy During Cesarean Section

NCT ID: NCT03095014

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-10-31

Brief Summary

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Cesarean Myomectomy, safety and effect on uterine cavity.

Detailed Description

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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.

Conditions

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Myomectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cesarean Myomectomy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cesarean Myomectomy

Myomectomy plus Cesarean section

Group Type EXPERIMENTAL

Cesarean Myomectomy

Intervention Type PROCEDURE

Myomectomy was done during Cesarean section

Cesarean section

Cesarean section only

Group Type ACTIVE_COMPARATOR

Cesarean section

Intervention Type PROCEDURE

Cesarean delivery

Interventions

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Cesarean Myomectomy

Myomectomy was done during Cesarean section

Intervention Type PROCEDURE

Cesarean section

Cesarean delivery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* pregnant
* full term
* had uterine myoma

Exclusion Criteria

* history of coagulation disorder
* antepartum hemorrhage
* previous myomectomy
* where additional operative procedures were performed
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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IBRAHIM ABD ELGAFOR

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ibrahim A el sharkwy

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Other Identifiers

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zuh- 5

Identifier Type: -

Identifier Source: org_study_id

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