Blood Loss in MyomectomyPhase 3SL-MISONCT02709564
Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy
A Phase 3 study testing Misoprostol 400 sublingual in people with Blood Loss in Myomectomy, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram 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
- Blood Loss in Myomectomy
- What is being tested?
- Misoprostol 400 sublingual
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Feb 2020
- 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.
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- 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
1 site in 1 country.
About this study
Official title: Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial
The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to decrease blood loss during and after the operation.
- Conditions
- Blood Loss in Myomectomy
- Being tested
- Misoprostol 400 sublingual, placebo 400 sublingual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 400 sublingualDrug
patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery
placebo 400 sublingualDrug
patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | 400 mg placebo Receives: Drug: placebo 400 sublingual |
| Group B | Active comparator | 400 microgram misoprostol Receives: Drug: Misoprostol 400 sublingual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amount of intraoperative blood loss
Measured: intraoperative
Secondary outcomes (1)
Change of hemoglobin 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 posted16 Mar 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss in MyomectomyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709564
- Sponsor's protocol ID
- misop 2
- Acronym
- SL-MISO
- Status last verified
- May 2020
- First submitted
- 11 Mar 2016
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02709564
- Acronym / sponsor ID
- SL-MISO / misop 2
- Conditions
- Blood Loss in Myomectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 16 Mar 2016 (estimated)
- 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 sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram 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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: placebo 400 sublingual400 mg placebo |
| Group B | Active comparator | Drug: Misoprostol 400 sublingual400 microgram misoprostol |
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
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Misoprostol 400 sublingualpatients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery | Drug | Group B |
| placebo 400 sublingualpatients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery | Drug | Group A |
Primary outcome
Mean amount of intraoperative blood loss
Time frame: intraoperative
1 secondary outcome
Change of hemoglobin after surgery
Time frame: 24 hours
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 7 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Misoprostol 400 sublingual in people with Blood Loss in Myomectomy, run by Assiut 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 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: finished, as of the sponsor's last update on 7 May 2020. 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. 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?
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?
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 7 May 2020.