Clinical trial · Interventional
Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy
Topical Tranexamic Acid Plus Perivascular Vasopressin to Decrease Bleeding at the Time of Abdominal Myomectomy: A Double-blinded Randomized Placebo-controlled Trial
NCT03880045CI-TRIAL-00038568unknownN/AClinicalTrials.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)
In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myoma | Myoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo to TA | Other | — | UNRESOLVED |
| Topical TA | Drug | — | UNRESOLVED |
| vasopressin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Topical TA plus vasopressin
- description
- Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%
- interventionNames
- Drug: Topical TA
- Drug: vasopressin
- type
- ACTIVE_COMPARATOR
- label
- placebo to TA plus vasopressin
- description
- Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid
- interventionNames
- Drug: vasopressin
- Other: placebo to TA
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging * Age ≥ 18 years and ≤ 50 years * Pre-operative hemoglobin \>8 g/dl * Ability to understand and the willingness to sign a written informed consent. * Admissible medical/surgical history * Five or less symptomatic uterine myomas * All myomas are subserous or intramural. * Uterine size less than 24 weeks of pregnancy Exclusion Criteria: * Patients who have had a prior abdominal myomectomy * Post-menopausal women * Patients with known bleeding/clotting disorders * Patients with a history of gynecologic malignancy * Hypertension. * Cardiac and Pulmonary Diseases. * Obesity (body mass index \> 30 kg/m2). * History of allergic reactions attributed to misoprostol * Cases that will require intraoperative conversion of myomectomy to hysterectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.