Myomectomy During CS: A Retrospective Cohort Study

August 28, 2020 updated by: Mansoura University

Myomectomy During Cesarean Section: A Retrospective Cohort Study

To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

178

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 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with uterine fibroid during the index pregnancy

Description

Inclusion Criteria:

  • Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery

Exclusion Criteria:

  • Antepartum hemorrhage
  • Blood diseases or bleeding tendencies.
  • Medical conditions complicating pregnancy.
  • Performed another surgical procedure at CS other than myomectomy.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CS with myomectomy
Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS
Procedure: Myomectomy
Surgical removal of uterine fibroid
CS without myomectomy
Women having uterine myoma with pregnancy and delivered by CS without myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deficit in hemoglobin level
Time Frame: 24 hours
Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 3 hours
Time to complete the procedure
3 hours
Postoperative hospital stay period
Time Frame: 7 days
Time from the end of operation to discharge from hospital
7 days

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Waleed El-refaie, MD, Port Said University
  • Study Director: Mohamed Hassan, MD, Mansoura University
  • Study Chair: Mohamed S Abdelhafez, MD, Mansoura 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, 2015

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/17.04.71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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