Cesarean SectionNCT03270605
Myomectomy During CS: A Retrospective Cohort Study
An observational study of Cesarean Section and Uterine Fibroid, run by Mansoura University.
Trial summary
To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Cesarean Section, Uterine Fibroid
- What is being tested?
- Myomectomy
- Type of treatment
- Surgery or procedure
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with uterine fibroid during the index pregnancy
Who may be able to join
- Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery
Who cannot join
- Antepartum hemorrhage
- Blood diseases or bleeding tendencies.
- Medical conditions complicating pregnancy.
- Performed another surgical procedure at CS other than myomectomy.
About this study
Official title: 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.
- Conditions
- Cesarean Section, Uterine Fibroid
- Being tested
- Myomectomy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyomectomyProcedure or surgery
Surgical removal of uterine fibroid
| Study group | Role | What they receive |
|---|---|---|
| CS with myomectomy | Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS Receives: Procedure: Myomectomy | |
| CS without myomectomy | Women having uterine myoma with pregnancy and delivered by CS without myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deficit in hemoglobin level
Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)
Measured: 24 hours
Secondary outcomes (2)
Operative time
Time to complete the procedure
Measured: 3 hours
Postoperative hospital stay period
Time from the end of operation to discharge from hospital
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waleed El-refaie, MD, Principal investigator, Port Said UniversityMohamed Hassan, MD, Study director, Mansoura UniversityMohamed S Abdelhafez, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270605
- Sponsor's protocol ID
- R/17.04.71
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myomectomy During Cesarean Section: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03270605
- Acronym / sponsor ID
- R/17.04.71
- Conditions
- Cesarean Section, Uterine Fibroid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS with myomectomy | – | Procedure: MyomectomyWomen having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS |
| CS without myomectomy | – | –Women having uterine myoma with pregnancy and delivered by CS without myomectomy |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with uterine fibroid during the index pregnancy
Key inclusion criteria (1 listed)
- Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery
Key exclusion criteria (4 listed)
- Antepartum hemorrhage
- Blood diseases or bleeding tendencies.
- Medical conditions complicating pregnancy.
- Performed another surgical procedure at CS other than myomectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyomectomySurgical removal of uterine fibroid | Procedure or surgery | CS with myomectomy |
Primary outcome
Deficit in hemoglobin level
Time frame: 24 hours
Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)
2 secondary outcomes
Operative time
Time frame: 3 hours
Postoperative hospital stay period
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed El-refaie, MD principal investigator
Port Said University
Mohamed Hassan, MD study director
Mansoura University
Mohamed S Abdelhafez, MD study chair
Mansoura University
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Uterine Fibroid, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deficit in hemoglobin level (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.