Purpose

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.

Category

IRB Number
20150554HU
NCT Number
NCT03064568
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Randal Robinson
(210) 567-4950
robinsonr3@uthscsa.edu

Principal Investigator
Randal Robinson

Jessica Perry
(210) 567-4930
perryj5@uthscsa.edu

Randal Robinson
(210) 567-4950
robinsonr3@uthscsa.edu



Eligibility

Eligible Ages
Between 20 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Prospective double-blinded study completed at a tertiary care center
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Randomization to treatment arm done by 3rd party. 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. The code will only be broken at time of data analysis once all patients have been enrolled.
Condition
  • Myomectomy; Surgical Blood Loss

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    Misoprostol 100Mcg Tab

    		Patients will receive misoprostol 400mcg per rectum 30 minutes preoperatively.
  • Drug: Misoprostol 100Mcg Tab

    Other names:

    • Cytotec

    • Placebo Comparator

    Placebo

    		Patients will receive identical inert tablets per rectum 30 minutes preoperatively.
  • Drug: Placebo

    Other names:

    • Placebo tablet

    •