Misoprostol, Blood Loss, MyomectomyPhase 4NCT02908295
Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study
A Phase 4 study testing Rectal Misoprostol in people with Misoprostol, Blood Loss, Myomectomy, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women undergoing myomectomy, both open and laparoscopic approach Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Misoprostol, Blood Loss, Myomectomy
- What is being tested?
- Rectal Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2016to 30 Apr 2018
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient provisionally diagnosed with leiomyoma of uterus with less than 10 cm diameter
- Patient undergoing myomectomy, both open and laparoscopic approach
- Patient aged 25 - 50 years
- Patient able to give free and informed consent and who agrees to participate bu signing the consent form
- Patient able to speak and understand Thai
- Patient able to complete the questionnaire
Who cannot join
- Patient who was pathologically diagnosed apart from leiomyoma
- Patient with leiomyoma FIGO type 0
- Patient who has medical conditions that increase bleeding tendency, such as thrombocytopenia, coagulopathy, renal insufficiency, uncontrolled diabetes mellitus, taking antiplatelets or anticoagulants less than 7 days prior the surgery
- Patient who takes prostaglandin analogs and/or antagonists (NSAIDS) less than 7 days prior the surgery.
- Patient who may take higher risks of misoprostol adverse effect such as hypertension, ischemic heart disease, glaucoma, asthma
- Patient who had and allergic reaction to misoprostol or vitamin B6
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women undergoing myomectomy, both open and laparoscopic approach
Read the detailed description
According to development of reproductive technology to assist infertile women, rate of myomectomy increases. During this operation, surgeons would deal with hypervascular masses with raw surfaces that tend to bleeding. Interventions to diminish bleeding were studied such as using misoprostol, vasopressin, transamenic acid along with mechanical intervention such as tourniquet and uterine artery ligation. But in Rajavithi hospital, such procedures aren't generally used because of fewer cases and also lacks of supporting data. Misoprostol, used in gynecologic patients for a long time with a wide safety margin acts at prostaglandin receptors of myometrium to stimulate contraction that constricts uterine vessels that lead to decreasing amount of bleeding during the operation. This led to the experimental study of rectal misoprostol administered at 15 - 30 minutes prior the operation to decrease blood loss and also blood transfusion rates. Our study also gather data about adverse effect that subject experienced after drug administration.
- Conditions
- Misoprostol, Blood Loss, Myomectomy
- Being tested
- Rectal Misoprostol, Placebo
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal MisoprostolDrug
Also called Cytotec
Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
PlaceboDrug
Also called Besix
Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation Receives: Drug: Rectal Misoprostol |
| B | Placebo comparator | Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intraoperative blood loss in both groups
Measured: Within 3 hours
Secondary outcomes (4)
Mean difference of hemoglobin
Measured: within 24 hours
Incidence of blood transfusion
Measured: within 72 hours
Incidence of unplanned operation
Measured: within 72 hours
Incidence of adverse events
Measured: within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion31 Dec 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Misoprostol, Blood Loss, MyomectomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908295
- Sponsor's protocol ID
- RJMISO
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2016
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02908295
- Acronym / sponsor ID
- RJMISO
- Conditions
- Misoprostol, Blood Loss, Myomectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 20 Sep 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.
Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women undergoing myomectomy, both open and laparoscopic approach
Detailed description
According to development of reproductive technology to assist infertile women, rate of myomectomy increases. During this operation, surgeons would deal with hypervascular masses with raw surfaces that tend to bleeding. Interventions to diminish bleeding were studied such as using misoprostol, vasopressin, transamenic acid along with mechanical intervention such as tourniquet and uterine artery ligation. But in Rajavithi hospital, such procedures aren't generally used because of fewer cases and also lacks of supporting data. Misoprostol, used in gynecologic patients for a long time with a wide safety margin acts at prostaglandin receptors of myometrium to stimulate contraction that constricts uterine vessels that lead to decreasing amount of bleeding during the operation. This led to the experimental study of rectal misoprostol administered at 15 - 30 minutes prior the operation to decrease blood loss and also blood transfusion rates. Our study also gather data about adverse effect that subject experienced after drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Rectal MisoprostolRectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation |
| B | Placebo comparator | Drug: PlaceboRectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient provisionally diagnosed with leiomyoma of uterus with less than 10 cm diameter
- Patient undergoing myomectomy, both open and laparoscopic approach
- Patient aged 25 - 50 years
- Patient able to give free and informed consent and who agrees to participate bu signing the consent form
- Patient able to speak and understand Thai
Key exclusion criteria (6 listed)
- Patient who was pathologically diagnosed apart from leiomyoma
- Patient with leiomyoma FIGO type 0
- Patient who has medical conditions that increase bleeding tendency, such as thrombocytopenia, coagulopathy, renal insufficiency, uncontrolled diabetes mellitus, taking antiplatelets or anticoagulants less than 7 days prior the surgery
- Patient who takes prostaglandin analogs and/or antagonists (NSAIDS) less than 7 days prior the surgery.
- Patient who may take higher risks of misoprostol adverse effect such as hypertension, ischemic heart disease, glaucoma, asthma
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 |
|---|---|---|
| Rectal MisoprostolAlso: CytotecRectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation | Drug | A |
| PlaceboAlso: BesixRectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation | Drug | B |
Primary outcome
Mean intraoperative blood loss in both groups
Time frame: Within 3 hours
4 secondary outcomes
Mean difference of hemoglobin
Time frame: within 24 hours
Incidence of blood transfusion
Time frame: within 72 hours
Incidence of unplanned operation
Time frame: within 72 hours
Incidence of adverse events
Time frame: within 72 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 23 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Misoprostol, Blood Loss, Myomectomy
Recruiting
Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
Myoma;Uterus, Myomectomy; Surgical Blood Loss
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 4 study testing Rectal Misoprostol in people with Misoprostol, Blood Loss, Myomectomy, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 6 inclusion and 6 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 23 Oct 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 Thailand. 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 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?
Mean intraoperative blood loss in both groups (time frame: Within 3 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 23 Oct 2020.