Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 20 - 50 |
| Updated: | 11/4/2018 |
| Start Date: | October 14, 2016 |
| End Date: | June 30, 2021 |
| Contact: | Sheena M Rippentrop, MD |
| Email: | rippentrop@uthscsa.edu |
| Phone: | 210-567-4924 |
Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss
when compared to vasopressin alone, which is our current practice at this time. The study
will be double-blinded with neither the patient nor the researcher knowing whether the
placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and
hematocrit, need for transfusion, and operative time among other measures of perioperative
morbidity to see if the addition of misoprostol makes a significant difference. We will also
observe patients to see if there are any side effects of misoprostol that make its use
undesirable.
when compared to vasopressin alone, which is our current practice at this time. The study
will be double-blinded with neither the patient nor the researcher knowing whether the
placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and
hematocrit, need for transfusion, and operative time among other measures of perioperative
morbidity to see if the addition of misoprostol makes a significant difference. We will also
observe patients to see if there are any side effects of misoprostol that make its use
undesirable.
All women with planned myomectomy receive Depo Leupron prior to surgery per standard care and
undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If
enrolled in the study, patients will be consented at their pre-op appointment for the study
and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be
randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per
rectum 30 minutes preoperatively. Randomization will be performed by a third party so that
neither the surgeon nor patient will know which intervention was performed, and interventions
will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have
all needed data corresponding with randomized code which will be broken at conclusion of
study and will be able to match code with patient's initials and medical record number after
study completion to analyze data. Myomectomy will then be performed per standard care with
the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.
undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If
enrolled in the study, patients will be consented at their pre-op appointment for the study
and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be
randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per
rectum 30 minutes preoperatively. Randomization will be performed by a third party so that
neither the surgeon nor patient will know which intervention was performed, and interventions
will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have
all needed data corresponding with randomized code which will be broken at conclusion of
study and will be able to match code with patient's initials and medical record number after
study completion to analyze data. Myomectomy will then be performed per standard care with
the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.
Inclusion Criteria:
- Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic
myomatous uterus
Exclusion Criteria:
- Patient with contraindication to misoprostol or vasopressin, personal history or
cardiac or pulmonary disease, history of prior myomectomy
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