HemorrhagePhase 4NCT01700478
Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
A Phase 4 study testing Misoprostol + vasopressin and Vasopressin in people with Hemorrhage, run by University Hospital of the West Indies at 1 site in Jamaica.
Trial summary
This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Misoprostol + vasopressin and Vasopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteJamaica
- Study dates
- Feb 2005to Apr 2005
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.
Who cannot join
- patients who have had previous myomectomy or previous pelvic surgery.
- patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
- patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy
This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.
Read the detailed description
A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.
- Conditions
- Hemorrhage
- Being tested
- Misoprostol + vasopressin, Vasopressin
- Keywords
- Myomectomy
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol + vasopressinDrug
Also called Cytotec
400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
VasopressinDrug
Also called Anti-diuretic hormone
Vasopressin was used in all patients during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol + vasopressin, Vasopressin | Experimental | Misoprostol 400ug given rectally one hour before surgery. Receives: Drug: Misoprostol + vasopressin; Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss in millilitres
Measured: At the time of surgery
Secondary outcomes (1)
A change in hemoglobin grams per decilitre
Measured: At baseline and 24hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startFeb 2005
- Primary completionApr 2005
- Study completionApr 2005
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 HemorrhageStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of the West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sharifa Frederick, University Hospital of the West Indies
- Investigators
- Sharifa K Frederick, dM, Principal investigator, University Hospital of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700478
- Sponsor's protocol ID
- MV-001
- Status last verified
- Oct 2012
- First submitted
- 25 Sep 2012
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Frederick S, Frederick J, Fletcher H, Reid M, Hardie M, Gardner W. A trial comparing the use of rectal misoprostol plus perivascular vasopressin with perivascular vasopressin alone to decrease myometrial bleeding at the time of abdominal myomectomy. Fertil Steril. 2013 Oct;100(4):1044-9. doi: 10.1016/j.fertnstert.2013.06.022. Epub 2013 Jul 19.
PubMed 23876539
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy
- ClinicalTrials.gov ID
- NCT01700478
- Acronym / sponsor ID
- MV-001
- Conditions
- Hemorrhage
- Keywords
- Myomectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital of the West IndiesUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 4 Oct 2012 (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.
This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.
Detailed description
A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Misoprostol + vasopressin, Vasopressin | Experimental | Drug: Misoprostol + vasopressin, Drug: VasopressinMisoprostol 400ug given rectally one hour before surgery. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.
Key exclusion criteria (3 listed)
- patients who have had previous myomectomy or previous pelvic surgery.
- patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
- patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.
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 + vasopressinAlso: Cytotec400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery. | Drug | Misoprostol + vasopressin, Vasopressin |
| VasopressinAlso: Anti-diuretic hormoneVasopressin was used in all patients during surgery. | Drug | Misoprostol + vasopressin, Vasopressin |
Primary outcome
Blood loss in millilitres
Time frame: At the time of surgery
1 secondary outcome
A change in hemoglobin grams per decilitre
Time frame: At baseline and 24hours after surgery
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 11 Feb 2013.
- Derived from this study: PubMed 23876539Frederick S, Frederick J, Fletcher H, Reid M, Hardie M, Gardner W. A trial comparing the use of rectal misoprostol plus perivascular vasopressin with perivascular vasopressin alone to decrease myometrial bleeding at the time of abdominal myomectomy. Fertil Steril. 2013 Oct;100(4):1044-9. doi: 10.1016/j.fertnstert.2013.06.022. Epub 2013 Jul 19.
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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.
Sharifa K Frederick, dM principal investigator
University Hospital of the West Indies
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 Misoprostol + vasopressin and Vasopressin in people with Hemorrhage, run by University Hospital of the West Indies at 1 site in Jamaica.
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 3 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 11 Feb 2013. 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 Jamaica. 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 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?
Blood loss in millilitres (time frame: At the time of surgery). 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 NCT01700478, 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 11 Feb 2013.