Myomectomy; Surgical Blood LossPhase 4NCT03064568
Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
A Phase 4 study testing Misoprostol 200Mcg Tab in people with Myomectomy; Surgical Blood Loss, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.
Trial summary
Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myomectomy; Surgical Blood Loss
- What is being tested?
- Misoprostol 200Mcg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Oct 2016to 18 Jun 2024
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus
Who cannot join
- Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Lukes Baptist Hospital
San Antonio, Texas, 78229
University Hospital
San Antonio, Texas, 78229
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and hematocrit, need for transfusion, and operative time among other measures of perioperative morbidity to see if the addition of misoprostol makes a significant difference. We will also observe patients to see if there are any side effects of misoprostol that make its use undesirable.
Read the detailed description
All women with planned myomectomy receive Depo Leupron prior to surgery per standard care and undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If enrolled in the study, patients will be consented at their pre-op appointment for the study and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per rectum 30 minutes preoperatively. Randomization will be performed by a third party so that neither the surgeon nor patient will know which intervention was performed, and interventions will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have all needed data corresponding with randomized code which will be broken at conclusion of study and will be able to match code with patient's initials and medical record number after study completion to analyze data. Myomectomy will then be performed per standard care with the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.
- Conditions
- Myomectomy; Surgical Blood Loss
- Being tested
- Misoprostol 200Mcg Tab, Placebo
- Keywords
- Myomectomy, Misoprostol, Vasopressin, Blood loss
- Medical subject headings
- Blood Loss, Surgical, Diabetes Insipidus, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 200Mcg TabDrug
Also called Cytotec
4 tablets will be inserted rectally
PlaceboDrug
Also called Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol 200Mcg Tab | Experimental | Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Receives: Drug: Misoprostol 200Mcg Tab |
| Placebo | Placebo comparator | Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Blood Loss
Estimated blood loss during surgery
Measured: Intraoperative
Secondary outcomes (4)
Febrile Morbiditiy
Number of participants that have evidence of fever or infection postoperatively
Measured: 24 hours postop
Need for Blood Transfusion
Number of participants that had a requirement of blood transfusion
Measured: intraoperative to 24 hours postoperative
Pain Score
Assessment of patient subjective pain with the visual analog scale prior to discharge from hospital. The scale used is a a likert pain scale where the participant selects their pain level between 0- 10, where 10 is the highest level of pain experienced.
Measured: 24 hours postop
Number of Participants With Medication Side-effects
Surveillance for any adverse side effects from misoprostol
Measured: 24 hours postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start14 Oct 2016
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
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.
- Other trials for Myomectomy; Surgical Blood LossStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Single group
- Model description
- Prospective double-blinded study completed at a tertiary care center
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randal M Robinson, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064568
- Sponsor's protocol ID
- HSC20150554H
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2017
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
- ClinicalTrials.gov ID
- NCT03064568
- Acronym / sponsor ID
- HSC20150554H
- Conditions
- Myomectomy; Surgical Blood Loss
- Keywords
- Myomectomy, Misoprostol, Vasopressin, Blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and hematocrit, need for transfusion, and operative time among other measures of perioperative morbidity to see if the addition of misoprostol makes a significant difference. We will also observe patients to see if there are any side effects of misoprostol that make its use undesirable.
Detailed description
All women with planned myomectomy receive Depo Leupron prior to surgery per standard care and undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If enrolled in the study, patients will be consented at their pre-op appointment for the study and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per rectum 30 minutes preoperatively. Randomization will be performed by a third party so that neither the surgeon nor patient will know which intervention was performed, and interventions will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have all needed data corresponding with randomized code which will be broken at conclusion of study and will be able to match code with patient's initials and medical record number after study completion to analyze data. Myomectomy will then be performed per standard care with the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective double-blinded study completed at a tertiary care center
| Arm | Type | Receives |
|---|---|---|
| Misoprostol 200Mcg Tab | Experimental | Drug: Misoprostol 200Mcg TabPatients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive identical inert tablets per rectum 30 minutes preoperatively. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus
Key exclusion criteria (1 listed)
- Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy
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 200Mcg TabAlso: Cytotec4 tablets will be inserted rectally | Drug | Misoprostol 200Mcg Tab |
| PlaceboAlso: Placebo tablet | Drug | Placebo |
Primary outcome
Surgical Blood Loss
Time frame: Intraoperative
Estimated blood loss during surgery
4 secondary outcomes
Febrile Morbiditiy
Time frame: 24 hours postop
Need for Blood Transfusion
Time frame: intraoperative to 24 hours postoperative
Pain Score
Time frame: 24 hours postop
Number of Participants With Medication Side-effects
Time frame: 24 hours postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Randal M Robinson, MD principal investigator
The University of Texas Health Science Center at San Antonio
3 sites 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 200Mcg Tab in people with Myomectomy; Surgical Blood Loss, run by The University of Texas Health Science Center at San Antonio at 3 sites 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 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2025). 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?
Surgical Blood Loss (time frame: Intraoperative). 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 Jul 2025.