Phase 4 Completed N=18 Randomized Triple-blind Prevention

Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Myomectomy; Surgical Blood Loss

Source: ClinicalTrials.gov NCT03064568 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcomePrimary: Surgical Blood Loss — 761; 691 ml

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.