- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04390659
Myomectomy During Cesarean Section Is This Aright Decision
May 13, 2020 updated by: khalid mohammed salama, Benha University
Myomectomy During Cesarean Section,Is This Aright Decision
myomectomy was done during cesarean section
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .Infusion of oxytocin during the operation and for 24 h later.
Study Type
Observational
Enrollment (Actual)
45
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
c s with uterine myoma
Description
Inclusion Criteria:
- women with diagnosed uterine myoma prior to pregnancy
- needed cesarean sections for various indications.
- Women with diagnosed uterine myoma during pregnancy and needed cesarean sections for various indications.
- Women with myoma diagnosed incidentally during labour.
Exclusion Criteria:
- Refusal of the women at any time before and during the operations.
- Cervical myoma.
- Atonic uterus after delivery of the baby.
- Women with bleeding disorders due to medical or obstetric causes.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
difficulty of cesarean myomectomy
Time Frame: during the procedure/surgery"
|
according to the site and type of myoma
|
during the procedure/surgery"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
4concentrations of hemoglobin
Time Frame: during the procedure
|
intra operative bleeding
|
during the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
August 15, 2014
Primary Completion (Actual)
March 20, 2019
Study Completion (Actual)
September 15, 2019
Study Registration Dates
First Submitted
April 29, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (Actual)
May 15, 2020
Study Record Updates
Last Update Posted (Actual)
May 15, 2020
Last Update Submitted That Met QC Criteria
May 13, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- khalid7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
master sheet
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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