MedPath

Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Phase 4
Completed
Conditions
Myomectomy; Surgical Blood Loss
Interventions
Registration Number
NCT03064568
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
18
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Misoprostol 100Mcg TabMisoprostol 100Mcg TabPatients will receive misoprostol 400mcg per rectum 30 minutes preoperatively.
PlaceboPlaceboPatients will receive identical inert tablets per rectum 30 minutes preoperatively.
Primary Outcome Measures
NameTimeMethod
Surgical blood lossIntraoperative

Estimated blood loss during surgery

Secondary Outcome Measures
NameTimeMethod
Febrile morbiditiy24 hours postop

Evidence of fever or infection postoperatively

Pain score24 hours postop

Assessment of patient subjective pain score

Need for blood transfusionintraoperative to 24 hours postoperative

Patient requirement of blood transfusion

Medication side-effects24 hours postop

Surveillance for any adverse side effects from misoprostol

Trial Locations

Locations (3)

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

© Copyright 2025. All Rights Reserved by MedPath