Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

NCT03064568 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC20150554H
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

Myomectomy; Surgical Blood Loss

Keywords

Myomectomy, Misoprostol, Vasopressin, Blood loss

Outcome Measures

Primary Outcomes (1)

• Surgical Blood Loss

  Estimated blood loss during surgery

  Intraoperative

Secondary Outcomes (4)

• Febrile Morbiditiy

  24 hours postop

• Need for Blood Transfusion

  intraoperative to 24 hours postoperative

• Pain Score

  24 hours postop

• Number of Participants With Medication Side-effects

  24 hours postop

Study Arms (2)

Misoprostol 200Mcg Tab

EXPERIMENTAL

Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively.

Drug: Misoprostol 200Mcg Tab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Misoprostol 200Mcg Tab DRUG

4 tablets will be inserted rectally

Also known as: Cytotec

Misoprostol 200Mcg Tab

Placebo DRUG

Also known as: Placebo tablet

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Patient must have a uterus to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus

You may not qualify if:

• Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (3)

St. Lukes Baptist Hospital

San Antonio, Texas, 78229, United States

Location

University Hospital

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Diabetes Insipidus; Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Sally Kabro
• Organization: UTHSCSA

kabro@uthscsa.edu

210-567-4950

Study Officials

• Randal M Robinson, MD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective double-blinded study completed at a tertiary care center

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: October 14, 2016
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)