Clinical trial NCT03064568: Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
Official title: Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myomectomy; Surgical Blood Loss
Keywords: Myomectomy, Misoprostol, Vasopressin, Blood loss
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 18
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective double-blinded study completed at a tertiary care center
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical blood loss
timeFrame: Intraoperative
Secondary outcomes:
measure: Febrile morbiditiy
timeFrame: 24 hours postop
measure: Need for blood transfusion
timeFrame: intraoperative to 24 hours postoperative
measure: Pain score
timeFrame: 24 hours postop
measure: Medication side-effects
timeFrame: 24 hours postop
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: St. Lukes Baptist Hospital
state: Texas
city: San Antonio
country: United States
facility: University Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Randal M Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: