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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Misoprostol + vasopressin, Vasopressin

Misoprostol 400ug given rectally one hour before surgery.

Group Type EXPERIMENTAL

Misoprostol + vasopressin

Intervention Type DRUG

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

Vasopressin

Intervention Type DRUG

Vasopressin was used in all patients during surgery.

Interventions

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Misoprostol + vasopressin

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

Intervention Type DRUG

Vasopressin

Vasopressin was used in all patients during surgery.

Intervention Type DRUG

Other Intervention Names

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Cytotec Anti-diuretic hormone

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes