Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

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.

Study Overview

• Status: Completed
• Conditions: Myomectomy; Surgical Blood Loss
• Intervention / Treatment: Drug: Placebo; Drug: Misoprostol 200Mcg Tab

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Hospital
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center
    • San Antonio, Texas, United States, 78229
      • St. Lukes Baptist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients will receive identical inert tablets per rectum 30 minutes preoperatively.	Drug: Placebo; Other Names: Placebo tablet
Experimental: Misoprostol 200Mcg Tab; Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively.	Drug: Misoprostol 200Mcg Tab; 4 tablets will be inserted rectally; Other Names: Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Blood Loss	Estimated blood loss during surgery	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Febrile Morbiditiy	Number of participants that have evidence of fever or infection postoperatively	24 hours postop
Need for Blood Transfusion	Number of participants that had a requirement of blood transfusion	intraoperative to 24 hours postoperative
Pain Score	Assessment of patient subjective pain with the visual analog scale prior to discharge from hospital. The scale used is a a likert pain scale where the participant selects their pain level between 0- 10, where 10 is the highest level of pain experienced.	24 hours postop
Number of Participants With Medication Side-effects	Surveillance for any adverse side effects from misoprostol	24 hours postop

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Randal M Robinson, MD, UT Health San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2016
• Primary Completion (Actual): June 18, 2024
• Study Completion (Actual): June 18, 2024

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Myomectomy, Misoprostol, Vasopressin, Blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Physiological Effects of Drugs; Gastrointestinal Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Oxytocics; Anti-Ulcer Agents; Misoprostol
• Other Study ID Numbers: HSC20150554H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes