Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy

University Hospital of the West Indies

Status and phase

Completed

Phase 4

Conditions

Hemorrhage

Treatments

Drug: Misoprostol + vasopressin

Drug: Vasopressin

Study type

Interventional

Funder types

Other

Identifiers

NCT01700478

MV-001

Details and patient eligibility

About

This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.

Full description

A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.

Enrollment

45 patients

Sex

Female

Ages

25 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.

Exclusion criteria

patients who have had previous myomectomy or previous pelvic surgery.
patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.