Obstetric Labor, PrematureNCT04390659
Myomectomy During Cesarean Section Is This Aright Decision
An observational study of Obstetric Labor, Premature, run by Benha University.
Trial summary
myomectomy was done during cesarean section Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor, Premature
- What is being tested?
- myomectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2014to 15 Sep 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: c s with uterine myoma
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Myomectomy During Cesarean Section,Is This Aright Decision
myomectomy was done during cesarean section
Read the 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.
- Conditions
- Obstetric Labor, Premature
- Being tested
- myomectomy
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myomectomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
difficulty of cesarean myomectomy
according to the site and type of myoma
Measured: during the procedure/surgery"
Secondary outcomes (1)
4concentrations of hemoglobin
intra operative bleeding
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start15 Aug 2014
- Primary completion20 Mar 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor, PrematureStudies 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid mohammed salama, Benha University
- Investigators
- khalid salama, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390659
- Sponsor's protocol ID
- khalid7
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: master sheet
Publications
Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
PubMed 11756390
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myomectomy During Cesarean Section,Is This Aright Decision
- ClinicalTrials.gov ID
- NCT04390659
- Acronym / sponsor ID
- khalid7
- Conditions
- Obstetric Labor, Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Aug 2014 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 15 May 2020 (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.
myomectomy was done during cesarean section
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- c s with uterine myoma
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| myomectomyThe 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. | Procedure or surgery | – |
Primary outcome
difficulty of cesarean myomectomy
Time frame: during the procedure/surgery"
according to the site and type of myoma
1 secondary outcome
4concentrations of hemoglobin
Time frame: during the procedure
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 15 May 2020.
- Results publication: PubMed 11756390Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
- Individual participant dataSharing planned: No. master sheet
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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.
khalid salama principal investigator
Benha University
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Labor, Premature, run by Benha 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 4 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 15 May 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?
difficulty of cesarean myomectomy (time frame: during the procedure/surgery"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390659, which also lists 1 linked publication.
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 15 May 2020; AzTrials last refreshed its copy on 31 Oct 2026.