Submucous Leiomyoma of UterusPhase 2/3NCT03930069
Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
A Phase 2/3 study testing Misoprostol and Vasopressin in people with Submucous Leiomyoma of Uterus, run by Zagazig University.
Trial summary
A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Submucous Leiomyoma of Uterus
- What is being tested?
- Misoprostol and Vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2016to 15 Mar 2017
- Phase
- Phase 2/3
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
- grade 0 and grade 1 submucous myomas
- less than 5 centimeters in diameter
Who cannot join
- Patients with grade 2 submucous myoma or more
- patients with submucous myomas larger than 5 cm in diameter
- postmenopausal women
- patients received GnRh analogue in last 6 months
- patients with anticoagulant therapy
- patients with endometrial premalignant or malignant pathologies
- patients with cardiovascular diseases, asthma or impaired kidney functions
About this study
Official title: Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .
Read the detailed description
This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .
- Conditions
- Submucous Leiomyoma of Uterus
- Being tested
- Misoprostol, Vasopressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Misotac
prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy
VasopressinDrug
one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.
| Study group | Role | What they receive |
|---|---|---|
| misoprostol group | Active comparator | 20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation. Receives: Drug: Misoprostol |
| vasopressin group | Active comparator | 20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative bleeding
subjective assessment of bleeding by the surgeon.
Measured: start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure
operative time
time needed for completion of myomectomy procedure
Measured: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure
haemoglobin and hematocrit deficit
haemoglobin and hematocrit values before and after myomectomy
Measured: 24 hours before myomectomy and 24 hour after myomectomy
Secondary outcomes (3)
Degree of visual clarity
visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter)
Measured: start with the first resectoscope myoma cut till the completion of myoma resection
Fluid deficit
calculation the fluid deficit between in flow volume and outflow volume
Measured: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure
time need for cervical dilatation
time needed to dilate the cervix to admit the operative hysterescope
Measured: start from grasping the cervix till insertion of hysterescope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start2 May 2016
- Primary completion30 Jan 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submucous Leiomyoma of UterusStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hossam mohamed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930069
- Sponsor's protocol ID
- Hysterscopioc myomectomy
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 29 Apr 2019
- 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 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
- ClinicalTrials.gov ID
- NCT03930069
- Acronym / sponsor ID
- Hysterscopioc myomectomy
- Conditions
- Submucous Leiomyoma of Uterus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 2 May 2016 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 29 Apr 2019 (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.
A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .
Detailed description
This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol group | Active comparator | Drug: Misoprostol20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation. |
| vasopressin group | Active comparator | Drug: Vasopressin20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
- grade 0 and grade 1 submucous myomas
- less than 5 centimeters in diameter
Key exclusion criteria (7 listed)
- Patients with grade 2 submucous myoma or more
- patients with submucous myomas larger than 5 cm in diameter
- postmenopausal women
- patients received GnRh analogue in last 6 months
- patients with anticoagulant therapy
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: Misotacprostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy | Drug | misoprostol group |
| Vasopressinone ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch. | Drug | vasopressin group |
Primary outcome
intraoperative bleeding
Time frame: start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure
subjective assessment of bleeding by the surgeon.
operative time
Time frame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure
time needed for completion of myomectomy procedure
haemoglobin and hematocrit deficit
Time frame: 24 hours before myomectomy and 24 hour after myomectomy
haemoglobin and hematocrit values before and after myomectomy
3 secondary outcomes
Degree of visual clarity
Time frame: start with the first resectoscope myoma cut till the completion of myoma resection
Fluid deficit
Time frame: start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure
time need for cervical dilatation
Time frame: start from grasping the cervix till insertion of hysterescope
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 29 Apr 2019.
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 2/3 study testing Misoprostol and Vasopressin in people with Submucous Leiomyoma of Uterus, run by Zagazig 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 3 inclusion and 7 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 29 Apr 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 bleeding (time frame: start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure). The study lists 3 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 29 Apr 2019.