DRUG
Misoprostol 200Mcg Tab
4 tablets will be inserted rectally
Status
Completed
Phase
Phase 4
Enrollment
18
Locations
3
Results
Posted
Publications
0
Study 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. 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.
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.
Interventions
DRUG
4 tablets will be inserted rectally
DRUG
Timeline
First posted
Feb 27, 2017
Study start
Oct 14, 2016
Primary completion
Jun 18, 2024
Study completion
Jun 18, 2024
Results posted
Jul 29, 2025
Registry updated
Jul 29, 2025
Outcomes
Surgical Blood Loss
Time frame · Intraoperative
Estimated blood loss during surgery
Febrile Morbiditiy
Time frame · 24 hours postop
Number of participants that have evidence of fever or infection postoperatively
Need for Blood Transfusion
Time frame · intraoperative to 24 hours postoperative
Number of participants that had a requirement of blood transfusion
Pain Score
Time frame · 24 hours postop
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.
Number of Participants With Medication Side-effects
Time frame · 24 hours postop
Surveillance for any adverse side effects from misoprostol
Eligibility
Inclusion Criteria: * Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus Exclusion Criteria: * Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
St. Lukes Baptist Hospital
San Antonio, Texas, United States
University Hospital
San Antonio, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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