Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Myomectomy; Surgical Blood Loss Clinical Trial

Official title:

Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064568
• Other study ID #: HSC20150554H
• Status: Recruiting
• Phase: Phase 4
• Start date: October 14, 2016
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Randal M Robinson, MD
• Phone: 210-567-4950
• Email: robinsonr3[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Myomectomy; Surgical Blood Loss

Intervention

Drug:
• Misoprostol 100Mcg Tab

• Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical blood loss	Estimated blood loss during surgery	Intraoperative
Secondary	Febrile morbiditiy	Evidence of fever or infection postoperatively	24 hours postop
Secondary	Need for blood transfusion	Patient requirement of blood transfusion	intraoperative to 24 hours postoperative
Secondary	Pain score	Assessment of patient subjective pain score	24 hours postop
Secondary	Medication side-effects	Surveillance for any adverse side effects from misoprostol	24 hours postop