Myoma;UterusPhase 3NCT05761418
Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy
A Phase 3 study testing Dinoprostone and Misoprostol in people with Myoma;Uterus, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myoma;Uterus
- What is being tested?
- Dinoprostone and Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 20 Feb 2023
- Phase
- Phase 3
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30-50 years
- all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.
Who cannot join
- contraindications to dinoprostone or misoprostol,
- active PID,
- history of pelvic/ ovarian endometriosis,
- females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy
Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy
Read the detailed description
Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy.
Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital
- Conditions
- Myoma;Uterus
- Being tested
- Dinoprostone, Misoprostol
- Keywords
- Uterine leiomyoma, misoprostol, dinoprostone
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinoprostoneDrug
Also called Dinoglandin
prostaglandin (PG) E2 analog
MisoprostolDrug
Also called Cytotec
prostaglandin (PG) E1 analog
| Study group | Role | What they receive |
|---|---|---|
| Dinoprostone | Experimental | Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively. Receives: Drug: Dinoprostone |
| Misoprostol | Experimental | will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively. Receives: Drug: Misoprostol |
| control | No intervention | received a placebo vaginally 2 hrs. preoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.
Measured: all time of the myomectomy operation
Secondary outcomes (1)
change hemoglobin levels
Pre and Postoperative hemoglobin levels
Measured: within 1 week before operation and 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Mar 2018
- Primary completion15 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Beni-Suef University, Principal investigator, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761418
- Sponsor's protocol ID
- REC-H-PhBSU-22021
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy
- ClinicalTrials.gov ID
- NCT05761418
- Acronym / sponsor ID
- REC-H-PhBSU-22021
- Conditions
- Myoma;Uterus
- Keywords
- Uterine leiomyoma, misoprostol, dinoprostone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 9 Mar 2023 (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.
Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy
Detailed description
Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy.
Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dinoprostone | Experimental | Drug: DinoprostoneWill receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively. |
| Misoprostol | Experimental | Drug: Misoprostolwill receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively. |
| control | No intervention | –received a placebo vaginally 2 hrs. preoperatively. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 30-50 years
- all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.
Key exclusion criteria (4 listed)
- contraindications to dinoprostone or misoprostol,
- active PID,
- history of pelvic/ ovarian endometriosis,
- females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier 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 |
|---|---|---|
| DinoprostoneAlso: Dinoglandinprostaglandin (PG) E2 analog | Drug | Dinoprostone |
| MisoprostolAlso: Cytotecprostaglandin (PG) E1 analog | Drug | Misoprostol |
Primary outcome
Blood loss
Time frame: all time of the myomectomy operation
quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.
1 secondary outcome
change hemoglobin levels
Time frame: within 1 week before operation and 24 hours after operation
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 9 Mar 2023.
- Individual participant dataSharing planned: No
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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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.
Beni-Suef University principal investigator
Faculty of Medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dinoprostone and Misoprostol in people with Myoma;Uterus, run by Beni-Suef University at 1 site in Egypt.
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 2 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Blood loss (time frame: all time of the myomectomy operation). 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 9 Mar 2023.