Myomectomy During Cesarean Section

Phase 1

Completed

• Conditions: Myomectomy
• Interventions: Procedure: Cesarean Myomectomy; Procedure: Cesarean section

• Registration Number: NCT03095014
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2015-12
• Study Completion: 2016-10
• Status Verified: 2017-03
• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-22
• Last Update Submitted: 2017-03-22
• Study First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• pregnant
• full term
• had uterine myoma

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cesarean Myomectomy	Cesarean Myomectomy	Myomectomy plus Cesarean section
Cesarean section	Cesarean section	Cesarean section only

Primary Outcome Measures

Name	Time	Method
Mean change in Haemoglobin in gm/dl	24 hours	pre-operative Haemoglobin minus post-operative Haemoglobin level

Secondary Outcome Measures

Name	Time	Method
Duration of operation in hours	2 hours	time to complete the procedure
intrauterine adesion adhesions	3 months	presence of uterine cavity adhesions