Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

• Sponsor: The University of Texas Health Science Center at San Antonio (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03064568
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 93.6
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myomectomy; Surgical Blood Loss	Drug: Misoprostol 100Mcg Tab; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective double-blinded study completed at a tertiary care centerProspective double-blinded study completed at a tertiary care center
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
• Actual Study Start Date: Oct 14, 2016
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Misoprostol 100Mcg Tab Patients will receive misoprostol 400mcg per rectum 30 minutes preoperatively.	Drug: Misoprostol 100Mcg Tab; Other Names: Cytotec
Placebo Comparator: Placebo Patients will receive identical inert tablets per rectum 30 minutes preoperatively.	Drug: Placebo; Other Names: Placebo tablet

Outcome Measures

Primary Outcome Measures

1. Surgical blood loss [Intraoperative]

   Estimated blood loss during surgery

Secondary Outcome Measures

1. Febrile morbiditiy [24 hours postop]

   Evidence of fever or infection postoperatively

2. Need for blood transfusion [intraoperative to 24 hours postoperative]

   Patient requirement of blood transfusion

3. Pain score [24 hours postop]

   Assessment of patient subjective pain score

4. Medication side-effects [24 hours postop]

   Surveillance for any adverse side effects from misoprostol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Lukes Baptist Hospital	San Antonio	Texas	United States	78229
2	University Hospital	San Antonio	Texas	United States	78229
3	University of Texas Health Science Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Randal M Robinson, MD, UT Health San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT03064568
• Other Study ID Numbers: HSC20150554H
• First Posted: Feb 27, 2017
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by The University of Texas Health Science Center at San Antonio: Myomectomy, Misoprostol, Vasopressin, Blood loss
• Additional relevant MeSH terms: Hemorrhage; Blood Loss, Surgical; Misoprostol

Study Results

No Results Posted as of Aug 8, 2022