Trial Outcomes & Findings for Misoprostol for Reduction of Blood Loss During Fibroid Surgery (NCT NCT02209545)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

47 participants

Primary outcome timeframe

Intra-operative

Results posted on

2023-09-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Misoprostol 13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation. Misoprostol: 13 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.	Placebo 26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation. Placebo: 26 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Overall Study STARTED	13	26
Overall Study COMPLETED	13	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misoprostol n=13 Participants 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.	Placebo n=26 Participants 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.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	0 Participants n=26 Participants	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants	26 Participants n=26 Participants	39 Participants n=39 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=26 Participants	0 Participants n=39 Participants
Sex: Female, Male Female	13 Participants n=13 Participants	26 Participants n=26 Participants	39 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=13 Participants	0 Participants n=26 Participants	0 Participants n=39 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Intra-operative

Population: No data was collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intra-operative

Population: No data was collected.

Intra-operative time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of surgery completion through discharge from hospital, an expected average period of 3 days

Population: No data was collected.

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).

Outcome measures

Outcome data not reported

Adverse Events

Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Magdy Milad

Northwestern Medicine

Phone: 3126946447

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place