Trial Outcomes & Findings for Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy (NCT NCT03064568)

NCT ID: NCT03064568

Last Updated: 2025-07-29

Results Overview

Estimated blood loss during surgery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 18 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2025-07-29

Participant Flow

There are no significant pre-assignment procedures beyond standard preoperative care and consent. Before randomization, patients undergo a physical exam, transvaginal ultrasound, receive Depo Leupron, have preoperative hemoglobin and hematocrit testing, and complete a preoperative pain assessment after providing consent.

Participant milestones

Measure	Misoprostol 200Mcg Tab Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Misoprostol 200Mcg Tab x4	Placebo Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo
Overall Study STARTED	8	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Misoprostol 200Mcg Tab n=8 Participants Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Four Misoprostol 200Mcg Tab	Placebo n=10 Participants Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo	Total n=18 Participants Total of all reporting groups
Age, Customized 20-50 years of age	8 Participants n=8 Participants	10 Participants n=10 Participants	18 Participants n=18 Participants
Sex/Gender, Customized Female	8 Participants n=8 Participants	10 Participants n=10 Participants	18 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Intraoperative

Population: Participants who receive an abdominal myomectomy

Estimated blood loss during surgery

Outcome measures

Measure	Misoprostol 200Mcg Tab n=8 Participants Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Misoprostol 200Mcg Tab x4	Placebo n=10 Participants Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo
Surgical Blood Loss	761 ml Standard Deviation 504	691 ml Standard Deviation 532

SECONDARY outcome

Timeframe: 24 hours postop

Population: Participants who receive an abdominal myomectomy

Number of participants that have evidence of fever or infection postoperatively

Outcome measures

Measure	Misoprostol 200Mcg Tab n=8 Participants Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Misoprostol 200Mcg Tab x4	Placebo n=10 Participants Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo
Febrile Morbiditiy	0 participants	0 participants

SECONDARY outcome

Timeframe: intraoperative to 24 hours postoperative

Population: Participants who receive an abdominal myomectomy

Number of participants that had a requirement of blood transfusion

Outcome measures

Measure	Misoprostol 200Mcg Tab n=8 Participants Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Misoprostol 200Mcg Tab x4	Placebo n=10 Participants Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo
Need for Blood Transfusion	1 participants	0 participants

SECONDARY outcome

Timeframe: 24 hours postop

Population: Participants who receive an abdominal myomectomy

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.

Outcome measures

Measure	Misoprostol 200Mcg Tab n=8 Participants Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Misoprostol 200Mcg Tab x4	Placebo n=10 Participants Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo
Pain Score	4.63 score on a scale Standard Deviation 2.39	4.65 score on a scale Standard Deviation 1.38

SECONDARY outcome

Timeframe: 24 hours postop

Population: Participants who receive an abdominal myomectomy

Surveillance for any adverse side effects from misoprostol

Outcome measures

Measure	Misoprostol 200Mcg Tab n=8 Participants Patients will receive misoprostol 800mcg per rectum 30 minutes preoperatively. Misoprostol 200Mcg Tab x4	Placebo n=10 Participants Patients will receive identical inert tablets per rectum 30 minutes preoperatively. Placebo
Number of Participants With Medication Side-effects	0 Participants	0 Participants

Adverse Events

Misoprostol 200Mcg Tab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sally Kabro

UTHSCSA

Phone: 210-567-4950

Email: kabro@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place