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Misoprostol for Blood Loss During Myomectomy
Study Summary
This trial is testing whether adding misoprostol to vasopressin decreases blood loss, compared to vasopressin alone. The study will be double-blinded, meaning neither the patient nor researcher will know who gets the placebo or misoprostol. Outcomes such as decreased hemoglobin and hematocrit, transfusion need, and operative time will be measured to see if misoprostol makes a significant difference. Patients will also be monitored for any side effects from misoprostol.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I cannot take misoprostol or vasopressin due to health reasons.I have a history of heart or lung disease.I have had surgery to remove fibroids from my uterus.I am a woman aged 20-50 planning to have surgery for fibroids.
- Group 1: Misoprostol 100Mcg Tab
- Group 2: Placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are senior citizens eligible to take part in this trial?
"This research is suitable for those aged between 20 and 50 years old."
How many participants are enrolled in this experiment?
"Affirmative. According to clinicaltrials.gov, this research is currently seeking participants with the initial posting date on October 14th 2016 and most recent update on August 5th 2022. The investigators are recruiting a total of 50 individuals from 3 centres."
What therapeutic conditions can be aided by Misoprostol 100Mcg Tab?
"Misoprostol 100Mcg Tab is a commonly prescribed medication for the treatment of missed abortion. Additionally, it can be helpful in addressing cases involving NSAID use, labor induction, and postpartum hemorrhage."
What kind of individuals is this research endeavor seeking?
"Potential applicants must have undergone myomectomy and experienced blood loss during surgery. Additionally, the age range for enrolment is between 20 to 50 years old; at maximum capacity this clinical trial will accept a total of 50 participants."
Can medical professionals attest to the safety of taking Misoprostol 100Mcg Tab?
"Studies have shown Misoprostol 100Mcg Tab to be a safe medical intervention, and thus it has earned the highest score of 3 on our team's evaluation. This is due to this treatment having gained Phase 4 approval."
Are there still opportunities for patients to participate in this research?
"According to the clinicaltrials.gov website, this study is in search of potential participants and has been since October 14th 2016 when it was first published; its most recent update being August 5th 2022."
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