Prostaglandin E2 "Misoprostol" Prior Abdominal MyomectomyPhase 4NCT02154932
Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
A Phase 4 study testing 2 doses 400 microgram misoprostol and single dose misoprostol in people with Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy, run by Mansoura University.
Trial summary
Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
- What is being tested?
- 2 doses 400 microgram misoprostol and single dose misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2013
- 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 20 to 50 years
- Women only
- Adult
Who may be able to join
- All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)
Who cannot join
- hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index >30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.
About this study
Official title: Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy: A Randomized Controlled Study
Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.
- Being tested
- 2 doses 400 microgram misoprostol, single dose misoprostol
- Keywords
- Myomectomy, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 doses 400 microgram misoprostolDrug
2 doses 400 microgram misoprostol, 3 and 1 hours
single dose misoprostolDrug
1 dose, 1 hours, prior surgery
| Study group | Role | What they receive |
|---|---|---|
| double dose misoprostol | Active comparator | 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Receives: Drug: 2 doses 400 microgram misoprostol |
| single dose Misoprostol | Active comparator | intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) Receives: Drug: single dose misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the operative time
The time from start till end of surgery
Measured: from skin to skin in minutes
intra and post-operative blood loss
collected soaked towels and sucked blood
Measured: during and 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostaglandin E2 "Misoprostol" Prior Abdominal MyomectomyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed M. badawy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154932
- Sponsor's protocol ID
- AB123
- Status last verified
- May 2014
- First submitted
- 31 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02154932
- Acronym / sponsor ID
- AB123
- Keywords
- Myomectomy, Misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Jun 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.
Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double dose misoprostol | Active comparator | Drug: 2 doses 400 microgram misoprostol2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). |
| single dose Misoprostol | Active comparator | Drug: single dose misoprostolintra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)
Key exclusion criteria (1 listed)
- hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index >30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.
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 |
|---|---|---|
| 2 doses 400 microgram misoprostol2 doses 400 microgram misoprostol, 3 and 1 hours | Drug | double dose misoprostol |
| single dose misoprostol1 dose, 1 hours, prior surgery | Drug | single dose Misoprostol |
Primary outcome
the operative time
Time frame: from skin to skin in minutes
The time from start till end of surgery
intra and post-operative blood loss
Time frame: during and 6 hours after surgery
collected soaked towels and sucked blood
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 3 Jun 2014.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2 doses 400 microgram misoprostol and single dose misoprostol in people with Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy, run by Mansoura 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: finished, as of the sponsor's last update on 3 Jun 2014. 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. 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?
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?
the operative time (time frame: from skin to skin in minutes). The study lists 2 primary outcomes in all. 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 3 Jun 2014.