Phase 4
N=18
Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
Myomectomy; Surgical Blood Loss
Bottom Line
View on ClinicalTrials.gov: NCT03064568 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Surgical Blood Loss — 761; 691 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Misoprostol 200Mcg Tab (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Blood Loss |
761; 691 | — |
| SECONDARY Febrile Morbiditiy |
0; 0 | — |
| SECONDARY Need for Blood Transfusion |
1; 0 | — |
| SECONDARY Pain Score |
4.63; 4.65 | — |
| SECONDARY Number of Participants With Medication Side-effects |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03064568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.