Trial | NCT01700478  Report issue

Title

Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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.
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.
Study Started
Feb 28
2005
Primary Completion
Apr 30
2005
Study Completion
Apr 30
2005
Last Update
Feb 11
2013
Estimate

Drug Misoprostol + vasopressin

400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.

  • Other names: Cytotec

Drug Vasopressin

Vasopressin was used in all patients during surgery.

  • Other names: Anti-diuretic hormone

Misoprostol + vasopressin, Vasopressin Experimental

Misoprostol 400ug given rectally one hour before surgery.

Criteria 

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.
No Results Posted