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Myomectomy During Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03095014
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
IBRAHIM ABD ELGAFOR, Zagazig University

Brief Summary:
Cesarean Myomectomy, safety and effect on uterine cavity.

Condition or disease Intervention/treatment Phase
Myomectomy Procedure: Cesarean Myomectomy Procedure: Cesarean section Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cesarean Myomectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cesarean Myomectomy : Safety and Risk of Intrauterine Synechiae
Actual Study Start Date : January 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cesarean Myomectomy
Myomectomy plus Cesarean section
Procedure: Cesarean Myomectomy
Myomectomy was done during Cesarean section

Active Comparator: Cesarean section
Cesarean section only
Procedure: Cesarean section
Cesarean delivery

Primary Outcome Measures :
  1. Mean change in Haemoglobin in gm/dl [ Time Frame: 24 hours ]
    pre-operative Haemoglobin minus post-operative Haemoglobin level

Secondary Outcome Measures :
  1. Duration of operation in hours [ Time Frame: 2 hours ]
    time to complete the procedure

  2. intrauterine adesion adhesions [ Time Frame: 3 months ]
    presence of uterine cavity adhesions

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • pregnant
  • full term
  • had uterine myoma

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03095014

Sponsors and Collaborators
Zagazig University
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Principal Investigator: ibrahim A el sharkwy Zagazig University
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Responsible Party: IBRAHIM ABD ELGAFOR, assistant professor, Zagazig University Identifier: NCT03095014    
Other Study ID Numbers: zuh- 5
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No