Myomectomy During Cesarean Section

March 22, 2017 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

Cesarean Myomectomy : Safety and Risk of Intrauterine Synechiae

Cesarean Myomectomy, safety and effect on uterine cavity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of operation in hours
Time Frame: 2 hours
time to complete the procedure
2 hours
intrauterine adesion adhesions
Time Frame: 3 months
presence of uterine cavity adhesions
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: ibrahim A el sharkwy, Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • zuh- 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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