Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Myomectomy; Surgical Blood Loss

Treatments: Drug: Misoprostol 100Mcg Tab; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03064568

HSC20150554H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Misoprostol 100Mcg Tab

Experimental group

Description:

Patients will receive misoprostol 400mcg per rectum 30 minutes preoperatively.

Treatment:

Drug: Misoprostol 100Mcg Tab

Placebo

Placebo Comparator group

Description:

Patients will receive identical inert tablets per rectum 30 minutes preoperatively.

Treatment:

Drug: Placebo