LeiomyomaPhase 3NCT02061657
Impact of Misoprostol on Blood Loss In Myomectomy Operations
A Phase 3 study testing Misoprostol in people with Leiomyoma, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2013to Jul 2014
- 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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal patients aged between 35 to 50 years old.
- Five or less symptomatic uterine myomas .
- Maximum diameter of the largest myoma is 6 cm .
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
Who cannot join
- History of previous surgery.
- Allergy to Misoprostol.
- Hypertension.
- Cardiac and Pulmonary diseases.
- Patients who have bleeding disorders.
- Anemia (Hb < 10g %).
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- Chronic endocrine or metabolic diseases such as Diabetes.
- Obesity (body mass index > 30 kg/m2).
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations
The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications
Read the detailed description
This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.
A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.
The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
- Conditions
- Leiomyoma
- Being tested
- Misoprostol, Placebo( for misoprostol)
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation
Placebo( for misoprostol)Drug
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
| Study group | Role | What they receive |
|---|---|---|
| Myomectomy, rectal Misoprostol | Experimental | 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation. Receives: Drug: Misoprostol |
| Myomectomy, Placebo | Active comparator | Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation. Receives: Drug: Placebo( for misoprostol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
Measured: time from peritoneum opening till its closure around (1 Hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Ahmed Elnaggar, Ain Shams University
- Investigators
- Abd El Mgeed I. Abd El Mgeed, Professor, Study chair, Ain Shams UniversityMohamed S. Ali, Professor, Study director, Ain Shams UniversityMohamed A. Abdel-Hafeez, Lecturer, Principal investigator, Ain Shams UniversityMina A. Yacoup, Fellow, Principal investigator, Ain Shams UniversityAhmed M. Elnaggar, Lecturer, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061657
- Sponsor's protocol ID
- AIN-1111-MM
- Status last verified
- Jul 2014
- First submitted
- 11 Feb 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14.
PubMed 26174128
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations
- ClinicalTrials.gov ID
- NCT02061657
- Acronym / sponsor ID
- AIN-1111-MM
- Conditions
- Leiomyoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Feb 2014 (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 this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications
Detailed description
This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.
A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.
The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myomectomy, rectal Misoprostol | Experimental | Drug: Misoprostol25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation. |
| Myomectomy, Placebo | Active comparator | Drug: Placebo( for misoprostol)Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenopausal patients aged between 35 to 50 years old.
- Five or less symptomatic uterine myomas .
- Maximum diameter of the largest myoma is 6 cm .
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
Key exclusion criteria (9 listed)
- History of previous surgery.
- Allergy to Misoprostol.
- Hypertension.
- Cardiac and Pulmonary diseases.
- Patients who have bleeding disorders.
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 |
|---|---|---|
| MisoprostolAlso: Cytotec25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation | Drug | Myomectomy, rectal Misoprostol |
| Placebo( for misoprostol)Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation. | Drug | Myomectomy, Placebo |
Primary outcome
intraoperative blood loss
Time frame: time from peritoneum opening till its closure around (1 Hour)
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 12 Aug 2014.
- Derived from this study: PubMed 26174128Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14.
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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.
Abd El Mgeed I. Abd El Mgeed, Professor study chair
Ain Shams University
Mohamed S. Ali, Professor study director
Ain Shams University
Mohamed A. Abdel-Hafeez, Lecturer principal investigator
Ain Shams 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 Misoprostol in people with Leiomyoma, run by Ain Shams 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 5 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 12 Aug 2014. 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?
intraoperative blood loss (time frame: time from peritoneum opening till its closure around (1 Hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061657, which also lists 1 linked publication.
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 12 Aug 2014.