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.
This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity. Intra-operative blood loss will be compared between groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
47
25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Northwestern University, Prentice Women's Hospital
Chicago, Illinois, United States
Estimated Intra-operative Blood Loss
Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.
Time frame: Intra-operative
Duration of Procedure
Intra-operative time
Time frame: Intra-operative
Length of Inpatient Hospitalization
Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.
Time frame: Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively
Post-operative Blood Transfusion
Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).
Time frame: From time of surgery completion through discharge from hospital, an expected average period of 3 days
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