MyomectomyPhase 3NCT04080375
Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy
A Phase 3 study testing Dinoprostone 3 mg in people with Myomectomy, run by Cairo University.
Trial summary
The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Myomectomy
- What is being tested?
- Dinoprostone 3 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2019to 10 Dec 2019
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- Age ≥ 18 years and ≤ 50 years
- Pre-operative hemoglobin >8 g/dl
- Ability to understand and the willingness to sign a written informed consent.
- Admissible medical/surgical history
- Five or less symptomatic uterine myomas
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
Who cannot join
- • Patients who have had a prior abdominal myomectomy
- Post-menopausal women
- Patients with known bleeding/clotting disorders
- Patients with a history of gynecologic malignancy
- Hypertension.
- Cardiac and Pulmonary diseases.
Show all 9Show fewer
- Obesity (body mass index > 30 kg/m2).
- History of allergic reactions attributed to misoprostol
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial
The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.
- Conditions
- Myomectomy
- Being tested
- Dinoprostone 3 mg, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinoprostone 3 mgDrug
the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
placeboDrug
the patient will take one vaginal tablet of placebo 1 hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| dinoprostone 3 mg | Experimental | patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery Receives: Drug: Dinoprostone 3 mg |
| placebo | Placebo comparator | patients will take 1 tablet of placebo 1 hour before the surgery Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amount of intraoperative blood loss
Mean amount of intraoperative blood loss in ml
Measured: intraoperative
Secondary outcomes (1)
Change of hemoglobin after surgery
Change of hemoglobin(g/dl) after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start10 Sep 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion10 Dec 2019 (estimated)
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.
- More trials run by Cairo 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080375
- Sponsor's protocol ID
- dinoprostone myomectomy
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04080375
- Acronym / sponsor ID
- dinoprostone myomectomy
- Conditions
- Myomectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 6 Sep 2019 (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.
The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dinoprostone 3 mg | Experimental | Drug: Dinoprostone 3 mgpatients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery |
| placebo | Placebo comparator | Drug: placebopatients will take 1 tablet of placebo 1 hour before the surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
Key exclusion criteria (9 listed)
- • Patients who have had a prior abdominal 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 |
|---|---|---|
| Dinoprostone 3 mgthe patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery | Drug | dinoprostone 3 mg |
| placebothe patient will take one vaginal tablet of placebo 1 hour before surgery | Drug | placebo |
Primary outcome
Mean amount of intraoperative blood loss
Time frame: intraoperative
Mean amount of intraoperative blood loss in ml
1 secondary outcome
Change of hemoglobin after surgery
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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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.
AHMED SAMY principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dinoprostone 3 mg in people with Myomectomy, run by Cairo 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY (+201100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean amount of intraoperative blood loss (time frame: intraoperative). 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 6 Sep 2019.