Misoprostol for Reduction of Blood Loss During Fibroid Surgery (NCT02209545) | Clinical Trial Compass
TerminatedPhase 4
Misoprostol for Reduction of Blood Loss During Fibroid Surgery
Stopped: The study was prematurely closed due to low enrollment rates.
United States47 participantsStarted 2014-10
Plain-language summary
The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
* Intraoperative use of vasopressin and uterine tourniquet is permissible
* Can have had prior Cesarean delivery
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
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol
* Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.