LeiomyomaPhase 4NCT03815344
Combined Vaginal Misoprostol and Perivascular Vasopressin
A Phase 4 study testing Standard and Standard-vaginal misoprostol in people with Leiomyoma and Laparoscopy, run by Antonios Likourezos at 1 site in United States.
Trial summary
Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma, Laparoscopy, Uterine Myomectomy
- What is being tested?
- Standard and Standard-vaginal misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy.
Who cannot join
- History of adverse reaction or allergy to Vasopressin.
- History of adverse reaction or allergy to Misoprostol.
- Medical contraindication to use of Vasopressin or Misoprostol
- Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
- Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.
- Any clinically significant even or condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy
Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.
Read the detailed description
Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough to warrant treatment in 20-50% of reproductive age women, including abnormal uterine bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is standard of care for symptomatic uterine fibroids, women desiring future child bearing require removal of the fibroids alone via uterine myomectomy, with re-construction of the uterus after removal. A well established risk to such a procedure is the operative blood loss, which can be quite significant due to the increased blood supply fibroids accumulate. Several interventions have been looked at as potential methods to help decrease operative blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. A known potential side effect of vasopressin is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently injected into the large vessels of the uterus. This limits the amount that can be safely used in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used during surgery, the associated potential risks limit the amount that can be safely administered. However, the addition Misoprostol, with a relatively safe side effect profile, can further improve control of the blood supply and decrease operative blood loss. Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories. While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or sublingual routes, the effect is maintained for a longer period of time, and is more conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged operative time associated with minimally invasive techniques when compared to traditional open approaches. This study aims to determine whether using vaginal Misoprostol in combination with Vasopressin is more effective at decreasing operative blood loss during robotic assisted laparoscopic myomectomy than Vasopressin alone.
- Conditions
- Leiomyoma, Laparoscopy, Uterine Myomectomy
- Being tested
- Standard, Standard-vaginal misoprostol
- Keywords
- Robot-assisted, Laparoscopic, vasopressin, misoprostol, blood loss
- Medical subject headings
- Leiomyoma, Diabetes Insipidus, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardDrug
Also called Perivascular vasopresssin
20 units diluted in 100mL of Normal Saline injected laparoscopic needle
Standard-vaginal misoprostolDrug
Also called perivascular vasopresssin-vaginal misprostol
20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. Receives: Drug: Standard-vaginal misoprostol |
| Standard-Vaginal Misoprostol | Experimental | Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement . Receives: Drug: Standard; Drug: Standard-vaginal misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Levels Difference Between Pre and Post Surgery.
The difference in hemoglobin levels between pre surgery and post surgery
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start26 Apr 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Pedram Bral, M.D., Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815344
- Sponsor's protocol ID
- 2017-03-09
- Status last verified
- Jan 2024
- First submitted
- 7 May 2018
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Publications
Iavazzo C, Mamais I, Gkegkes ID. Use of misoprostol in myomectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2015 Dec;292(6):1185-91. doi: 10.1007/s00404-015-3779-x. Epub 2015 Jun 4.
PubMed 26041328Kalogiannidis I, Xiromeritis P, Prapas N, Prapas Y. Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial. Clin Exp Obstet Gynecol. 2011;38(1):46-9.
PubMed 21485725Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.
PubMed 7026295Cohen SL, Senapati S, Gargiulo AR, Srouji SS, Tu FF, Solnik J, Hur HC, Vitonis A, Jonsdottir GM, Wang KC, Einarsson JI. Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial. BJOG. 2017 Jan;124(2):262-268. doi: 10.1111/1471-0528.14179. Epub 2016 Jun 30.
PubMed 27362908Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.
PubMed 25125317
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy
- ClinicalTrials.gov ID
- NCT03815344
- Acronym / sponsor ID
- 2017-03-09
- Conditions
- Leiomyoma, Laparoscopy, Uterine Myomectomy
- Keywords
- Robot-assisted, Laparoscopic, vasopressin, misoprostol, blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.
Detailed description
Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough to warrant treatment in 20-50% of reproductive age women, including abnormal uterine bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is standard of care for symptomatic uterine fibroids, women desiring future child bearing require removal of the fibroids alone via uterine myomectomy, with re-construction of the uterus after removal. A well established risk to such a procedure is the operative blood loss, which can be quite significant due to the increased blood supply fibroids accumulate. Several interventions have been looked at as potential methods to help decrease operative blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. A known potential side effect of vasopressin is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently injected into the large vessels of the uterus. This limits the amount that can be safely used in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used during surgery, the associated potential risks limit the amount that can be safely administered. However, the addition Misoprostol, with a relatively safe side effect profile, can further improve control of the blood supply and decrease operative blood loss. Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories. While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or sublingual routes, the effect is maintained for a longer period of time, and is more conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged operative time associated with minimally invasive techniques when compared to traditional open approaches. This study aims to determine whether using vaginal Misoprostol in combination with Vasopressin is more effective at decreasing operative blood loss during robotic assisted laparoscopic myomectomy than Vasopressin alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Drug: Standard-vaginal misoprostolUse of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. |
| Standard-Vaginal Misoprostol | Experimental | Drug: Standard, Drug: Standard-vaginal misoprostolUse of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy.
Key exclusion criteria (7 listed)
- History of adverse reaction or allergy to Vasopressin.
- History of adverse reaction or allergy to Misoprostol.
- Medical contraindication to use of Vasopressin or Misoprostol
- Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
- Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.
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 |
|---|---|---|
| StandardAlso: Perivascular vasopresssin20 units diluted in 100mL of Normal Saline injected laparoscopic needle | Drug | Standard-Vaginal Misoprostol |
| Standard-vaginal misoprostolAlso: perivascular vasopresssin-vaginal misprostol20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg | Drug | Standard, Standard-Vaginal Misoprostol |
Primary outcome
Hemoglobin Levels Difference Between Pre and Post Surgery.
Time frame: 1 hour
The difference in hemoglobin levels between pre surgery and post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26041328Iavazzo C, Mamais I, Gkegkes ID. Use of misoprostol in myomectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2015 Dec;292(6):1185-91. doi: 10.1007/s00404-015-3779-x. Epub 2015 Jun 4.
- Results publication: PubMed 21485725Kalogiannidis I, Xiromeritis P, Prapas N, Prapas Y. Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial. Clin Exp Obstet Gynecol. 2011;38(1):46-9.
- Results publication: PubMed 7026295Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.
- Results publication: PubMed 27362908Cohen SL, Senapati S, Gargiulo AR, Srouji SS, Tu FF, Solnik J, Hur HC, Vitonis A, Jonsdottir GM, Wang KC, Einarsson JI. Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial. BJOG. 2017 Jan;124(2):262-268. doi: 10.1111/1471-0528.14179. Epub 2016 Jun 30.
- Results publication: PubMed 25125317Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.
- FDA websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
Pedram Bral, M.D. principal investigator
Maimonides Medical Center
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 Standard and Standard-vaginal misoprostol in people with Leiomyoma and Laparoscopy, run by Antonios Likourezos at 1 site in United States.
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 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 9 Jan 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin Levels Difference Between Pre and Post Surgery. (time frame: 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 NCT03815344, which also lists 5 linked publications.
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 9 Jan 2024.