Clinical trial · Interventional
Combined Vaginal Misoprostol and Perivascular Vasopressin
A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy
NCT03815344CI-TRIAL-00072829completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopy | — | UNRESOLVED | — |
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Uterine Myomectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard | Drug | — | UNRESOLVED |
| Standard-vaginal misoprostol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard
- description
- Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.
- interventionNames
- Drug: Standard-vaginal misoprostol
- type
- EXPERIMENTAL
- label
- Standard-Vaginal Misoprostol
- description
- Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .
- interventionNames
- Drug: Standard
- Drug: Standard-vaginal misoprostol
Primary outcomes (1)
- measure
- Hemoglobin Levels Difference Between Pre and Post Surgery.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy. Exclusion Criteria: 1. History of adverse reaction or allergy to Vasopressin. 2. History of adverse reaction or allergy to Misoprostol. 3. Medical contraindication to use of Vasopressin or Misoprostol 4. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue. 5. 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. 6. 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. 7. Pregnant women
References
Publications (5)
- RESULTIavazzo C, Mamais I, Gkegkes ID. Use of misoprostol in myomectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2015 Dec;292(6):1185-91. doi: 10.1007/s00404-015-3779-x. Epub 2015 Jun 4. PMID 26041328
- RESULTKalogiannidis I, Xiromeritis P, Prapas N, Prapas Y. Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial. Clin Exp Obstet Gynecol. 2011;38(1):46-9. PMID 21485725
- RESULTButtram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4. PMID 7026295
- RESULTCohen SL, Senapati S, Gargiulo AR, Srouji SS, Tu FF, Solnik J, Hur HC, Vitonis A, Jonsdottir GM, Wang KC, Einarsson JI. Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial. BJOG. 2017 Jan;124(2):262-268. doi: 10.1111/1471-0528.14179. Epub 2016 Jun 30. PMID 27362908
- RESULTKongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5. PMID 25125317