MyomectomyPhase 1NCT03095014
Myomectomy During Cesarean Section
A Phase 1 study testing Cesarean Myomectomy and Cesarean section in people with Myomectomy, run by Zagazig University.
Trial summary
Cesarean Myomectomy, safety and effect on uterine cavity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myomectomy
- What is being tested?
- Cesarean Myomectomy and Cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Oct 2016
- Phase
- Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant
- full term
- had uterine myoma
Who cannot join
- history of coagulation disorder
- antepartum hemorrhage
- previous myomectomy
- where additional operative procedures were performed
About this study
Official title: Cesarean Myomectomy : Safety and Risk of Intrauterine Synechiae
Cesarean Myomectomy, safety and effect on uterine cavity.
Read the 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.
- Conditions
- Myomectomy
- Being tested
- Cesarean Myomectomy, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean MyomectomyProcedure or surgery
Myomectomy was done during Cesarean section
Cesarean sectionProcedure or surgery
Cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Myomectomy | Experimental | Myomectomy plus Cesarean section Receives: Procedure: Cesarean Myomectomy |
| Cesarean section | Active comparator | Cesarean section only Receives: Procedure: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Haemoglobin in gm/dl
pre-operative Haemoglobin minus post-operative Haemoglobin level
Measured: 24 hours
Secondary outcomes (2)
Duration of operation in hours
time to complete the procedure
Measured: 2 hours
intrauterine adesion adhesions
presence of uterine cavity adhesions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startJan 2010
- Primary completionDec 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomectomyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cesarean Myomectomy
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM ABD ELGAFOR, Zagazig University
- Investigators
- ibrahim A el sharkwy, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095014
- Sponsor's protocol ID
- zuh- 5
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Myomectomy : Safety and Risk of Intrauterine Synechiae
- ClinicalTrials.gov ID
- NCT03095014
- Acronym / sponsor ID
- zuh- 5
- Conditions
- Myomectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Mar 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.
Cesarean Myomectomy, safety and effect on uterine cavity.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cesarean Myomectomy
| Arm | Type | Receives |
|---|---|---|
| Cesarean Myomectomy | Experimental | Procedure: Cesarean MyomectomyMyomectomy plus Cesarean section |
| Cesarean section | Active comparator | Procedure: Cesarean sectionCesarean section only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant
- full term
- had uterine myoma
Key exclusion criteria (4 listed)
- history of coagulation disorder
- antepartum hemorrhage
- previous myomectomy
- where additional operative procedures were performed
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 |
|---|---|---|
| Cesarean MyomectomyMyomectomy was done during Cesarean section | Procedure or surgery | Cesarean Myomectomy |
| Cesarean sectionCesarean delivery | Procedure or surgery | Cesarean section |
Primary outcome
Mean change in Haemoglobin in gm/dl
Time frame: 24 hours
pre-operative Haemoglobin minus post-operative Haemoglobin level
2 secondary outcomes
Duration of operation in hours
Time frame: 2 hours
intrauterine adesion adhesions
Time frame: 3 months
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 29 Mar 2017.
- Individual participant dataSharing planned: No
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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.
ibrahim A el sharkwy principal investigator
Zagazig University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cesarean Myomectomy and Cesarean section in people with Myomectomy, run by Zagazig 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 3 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 29 Mar 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean change in Haemoglobin in gm/dl (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 29 Mar 2017.