Fibroids
Conditions
Keywords
fibroids, leiomyomata, blood loss, misoprostol
Brief summary
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.
Detailed description
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.
Interventions
DRUGMisoprostol
25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
DRUGPlacebo
25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months * Age ≥ 18 years and ≤ 50 years * Pre-operative hemoglobin \>8 g/dl * Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure. * Ability to understand and the willingness to sign a written informed consent. * Admissible medical/surgical history * Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills * Intraoperative use of vasopressin and uterine tourniquet is permissible * Can have had prior Cesarean delivery
Exclusion criteria
* Patients who have had a prior abdominal myomectomy * Post-menopausal women * Patients with known bleeding/clotting disorders * Patients with a history of gynecologic malignancy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol * Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Intra-operative Blood Loss | Intra-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Procedure | Intra-operative | Intra-operative time |
| Length of Inpatient Hospitalization | Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively | 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. |
| Post-operative Blood Transfusion | From time of surgery completion through discharge from hospital, an expected average period of 3 days | 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). |
Countries
United States
Participant flow
Pre-assignment details
Forty-seven patients enrolled in the study by signing the informed consent form. However, due to the premature closure, not all participants had the opportunity to undergo the intended intervention. Of these, 39 participants successfully completed the intervention, while 8 participants could not undergo the intervention as planned.
Participants by arm
| Arm | Count |
|---|---|
| Misoprostol 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
Misoprostol: 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation. | 13 |
| Placebo 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Placebo: 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation. | 26 |
| Total | 39 |
Baseline characteristics
| Characteristic | Misoprostol | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 26 Participants | 39 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 26 |
| other Total, other adverse events | 0 / 13 | 0 / 26 |
| serious Total, serious adverse events | 0 / 13 | 0 / 26 |
Outcome results
Primary
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
Population: No data was collected.
Secondary
Duration of Procedure
Intra-operative time
Time frame: Intra-operative
Population: No data was collected.
Secondary
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
Population: No data was collected.
Secondary
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
Population: No data was collected.