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Misoprostol for Blood Loss During Myomectomy

Phase 4
Recruiting
Led By Randal M Robinson, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours postop
Awards & highlights

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.

Who is the study for?
This trial is for women aged 20-50 planning to have abdominal myomectomy surgery for a condition involving noncancerous growths in the uterus. It's not open to those with allergies to misoprostol or vasopressin, or with a history of heart, lung disease, or previous myomectomy.Check my eligibility
What is being tested?
The study tests if adding Misoprostol to the usual vasopressin treatment reduces blood loss during surgery more effectively than vasopressin alone. Participants will be randomly given either Misoprostol or a placebo without knowing which one they received.See study design
What are the potential side effects?
Potential side effects of Misoprostol may include gastrointestinal symptoms like cramps and diarrhea, as well as possible allergic reactions. The trial will monitor these outcomes closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 20-50 planning to have surgery for fibroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours postop
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours postop for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical blood loss
Secondary outcome measures
Febrile morbiditiy
Medication side-effects
Need for blood transfusion
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Misoprostol 100Mcg TabExperimental Treatment1 Intervention
Patients will receive misoprostol 400mcg per rectum 30 minutes preoperatively.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive identical inert tablets per rectum 30 minutes preoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Misoprostol
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,364 Total Patients Enrolled
Randal M Robinson, MDPrincipal InvestigatorUT Health San Antonio

Media Library

Misoprostol 100Mcg Tab Clinical Trial Eligibility Overview. Trial Name: NCT03064568 — Phase 4
Myomectomy Research Study Groups: Misoprostol 100Mcg Tab, Placebo
Myomectomy Clinical Trial 2023: Misoprostol 100Mcg Tab Highlights & Side Effects. Trial Name: NCT03064568 — Phase 4
Misoprostol 100Mcg Tab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03064568 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens eligible to take part in this trial?

"This research is suitable for those aged between 20 and 50 years old."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
2016. "Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03064568.
~2 spots leftby Aug 2024
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