Phase 4
Completed N=74
Combined Vaginal Misoprostol and Perivascular Vasopressin
Leiomyoma · Laparoscopy · Uterine Myomectomy
Source: ClinicalTrials.gov NCT03815344 ↗
Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Hemoglobin Levels Difference Between Pre and Post Surgery. — 0.76; 0.93 g/dL
◆ Published Evidence
Highly cited
1,566citations · ~35 / year
Uterine leiomyomata: etiology, symptomatology, and management.
Summary
Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.
Linked Publications (5)
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Uterine leiomyomata: etiology, symptomatology, and management.
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Interventions to reduce haemorrhage during myomectomy for fibroids.
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Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial.
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Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial.
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Use of misoprostol in myomectomy: a systematic review and meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Levels Difference Between Pre and Post Surgery. |
0.76; 0.93 | — |
Eligibility Criteria
Inclusion Criteria
- Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy.
Exclusion Criteria
- History of adverse reaction or allergy to Vasopressin.
- History of adverse reaction or allergy to Misoprostol.
- Medical contraindication to use of Vasopressin or Misoprostol
- Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
- Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.
- Any clinically significant even or condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course.
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT03815344) and the linked publication. 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.