MyomaNCT04694677
Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.
A study testing women receiving tranexamic acid and women receiving misoprostol in people with Myoma, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myoma
- What is being tested?
- women receiving tranexamic acid and women receiving misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to 10 Sep 2021
- Phase
- Interventional
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with myomas
Who cannot join
- with with malignant lesions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Safety of Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Myomectomy.
Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group
Read the detailed description
Although most of them are asymptomatic, 20-50% of fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract, infertility, and recurrent pregnancy losses, where surgical intervention is often indicated
- Conditions
- Myoma
- Being tested
- women receiving tranexamic acid, women receiving misoprostol
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
women receiving tranexamic acidDrug
women receiving tranexamic acid during myomectomy
women receiving misoprostolDrug
women receiving misoprostol in myomectomy
| Study group | Role | What they receive |
|---|---|---|
| women receiving tranexamic acid | Active comparator | Not described Receives: Drug: women receiving tranexamic acid |
| women receiving misoprostol | Active comparator | Not described Receives: Drug: women receiving misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of women who will have less blood loss
how many women will have less blood loss
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start10 Jan 2021 (estimated)
- Primary completion15 Aug 2021 (estimated)
- Study completion10 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, Study director, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694677
- Sponsor's protocol ID
- Myomectomy
- Status last verified
- Jan 2021
- First submitted
- 2 Jan 2021
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Myomectomy.
- ClinicalTrials.gov ID
- NCT04694677
- Acronym / sponsor ID
- Myomectomy
- Conditions
- Myoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Jan 2021 (estimated)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 5 Jan 2021 (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.
Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group
Detailed description
Although most of them are asymptomatic, 20-50% of fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract, infertility, and recurrent pregnancy losses, where surgical intervention is often indicated
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women receiving tranexamic acid | Active comparator | Drug: women receiving tranexamic acid |
| women receiving misoprostol | Active comparator | Drug: women receiving misoprostol |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with myomas
Key exclusion criteria (1 listed)
- with with malignant lesions
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 |
|---|---|---|
| women receiving tranexamic acidwomen receiving tranexamic acid during myomectomy | Drug | women receiving tranexamic acid |
| women receiving misoprostolwomen receiving misoprostol in myomectomy | Drug | women receiving misoprostol |
Primary outcome
the number of women who will have less blood loss
Time frame: 48 hours
how many women will have less blood loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Related trials for Myoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 4
Prescription of Letrozole for Uterine Myoma
Leiomyoma, Uterine, Leiomyoma
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
Uterine Fibroids (Leiomyoma), Uterine Myoma
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.
Mahmoud Alalfy study director
Algezeera hospitaland National Research Centre ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing women receiving tranexamic acid and women receiving misoprostol in people with Myoma, run by Aljazeera Hospital 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 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 5 Jan 2021. 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.
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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of women who will have less blood loss (time frame: 48 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 5 Jan 2021.