CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Misoprostol 200Mcg Tab +1 moredrug
Likely dose
Misoprostol 800 mcg rectally (4 tablets of 200 mcg each)AI-extracted
Key inclusion· 2
  • Female age 20-50 years old
  • Planned abdominal myomectomy for symptomatic uterine fibroids
Key exclusion· 4
  • Contraindication to misoprostol or vasopressin
  • Personal history of cardiac disease
  • Personal history of pulmonary disease
  • Prior myomectomy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03064568
NCT03064568Phase 4Completed

Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

The University of Texas Health Science Center at San Antonio·interventional·Posted Feb 27, 2017·Updated Jul 29, 2025

In Brief

A Phase 4 clinical trial evaluating Misoprostol 200Mcg Tab and Placebo for Myomectomy; Surgical Blood Loss. Completed, enrolled 18 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 27, 2017
Enrollment StartOct 14, 2016
Primary CompletionJun 18, 2024
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 9.3 years ago

Interventions

Misoprostol 200Mcg Tabdrug

4 tablets will be inserted rectally

Placebodrug