MyomectomyPhase 4NCT04357002
Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy
A Phase 4 study testing intravenous tranexamic acid and vaginal dinoprostone in people with Myomectomy, run by Cairo University.
Trial summary
the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Myomectomy
- What is being tested?
- intravenous tranexamic acid and vaginal dinoprostone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2020to 15 Oct 2020
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- symptomatic fibroids candidate for abdominal myomectomy
Who cannot join
- patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating Safety and Efficacy of Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Reducing Intraoperative Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial
the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy
- Conditions
- Myomectomy
- Being tested
- intravenous tranexamic acid, vaginal dinoprostone, vaginal placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous tranexamic acidDrug
patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.
vaginal dinoprostoneDrug
patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
vaginal placeboDrug
patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
| Study group | Role | What they receive |
|---|---|---|
| intravenous tranexamic acid | Experimental | patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision. Receives: Drug: intravenous tranexamic acid |
| vaginal dinoprostone | Active comparator | patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision Receives: Drug: vaginal dinoprostone |
| placebo | Placebo comparator | patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision Receives: Drug: vaginal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
estimation of intraoperative blood loss in ml
Measured: one hour
Secondary outcomes (1)
blood transfusion
need for intraoperative or postoperative blood transfusion
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 posted22 Apr 2020
- Study start30 Apr 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion15 Oct 2020 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357002
- Sponsor's protocol ID
- dinoprostone tranexamic acid
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Apr 2020
- 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 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety and Efficacy of Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Reducing Intraoperative Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04357002
- Acronym / sponsor ID
- dinoprostone tranexamic acid
- Conditions
- Myomectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 22 Apr 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.
the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intravenous tranexamic acid | Experimental | Drug: intravenous tranexamic acidpatients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision. |
| vaginal dinoprostone | Active comparator | Drug: vaginal dinoprostonepatients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision |
| placebo | Placebo comparator | Drug: vaginal placebopatients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic fibroids candidate for abdominal myomectomy
Key exclusion criteria (1 listed)
- patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid
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 |
|---|---|---|
| intravenous tranexamic acidpatients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision. | Drug | intravenous tranexamic acid |
| vaginal dinoprostonepatients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision | Drug | vaginal dinoprostone |
| vaginal placebopatients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision | Drug | placebo |
Primary outcome
intraoperative blood loss
Time frame: one hour
estimation of intraoperative blood loss in ml
1 secondary outcome
blood transfusion
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 22 Apr 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous tranexamic acid and vaginal dinoprostone 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 1 inclusion and 1 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 22 Apr 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
intraoperative blood loss (time frame: one hour). 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 22 Apr 2020.