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.

Condition

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.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

St. Lukes Baptist Hospital
San Antonio, Texas 78229
Contact:
Sheena Rippentrop, MD
210-567-4924
rippentrop@uthscsa.edu

University of Texas Health Science Center
San Antonio, Texas 78229
Contact:
Sheena Rippentrop, MD
210-567-4924
rippentrop@uthscsa.edu

More Details

NCT ID
NCT03064568
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Sheena M Rippentrop, MD
210-567-4924
rippentrop@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.