Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy

Pak Emirates Military Hospital

Status and phase: Completed; Phase 3

Conditions: Uterine Myoma; Blood Loss, Surgical

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05108597

25102021

Details and patient eligibility

About

A total of 200 women for elective abdominal myomectomy were randomly allocated into two groups.

100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®) through the rectal route prior to surgery and 100 were in control group, in which no drug was administered.

Full description

After getting approval from hospital's ethical committee, patients eligible for the study were recruited in the study according to the selection criteria. Before surgery, after taking informed written consent, patient's detailed history including demographics, parity & BMI was recorded. Uterine size was assessed by bimanual pelvic examination. Patients undergoing myomectomy were randomly divided into 2 groups using lottery method. In experimental group Misoprostol 400ug was administered per rectally prior to surgery. In control group, no drug was administered.

The surgical procedural elements, the surgeon or surgeons performing the procedure and the use of antibiotics as well as anesthetic agents was standardized to remove any bias. Intraoperative blood loss was recorded by a single trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ASA physical status class I-II
2. Intramural or subserosal fibroids - diagnosed on ultrasound
3. Candidates for elective abdominal myomectomy

Exclusion criteria

1. Pre-operative Hemoglobin < 10 g/dl
2. Patient who received Danazol or GnRH analogues before surgery
3. No other systemic or metabolic disease

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Misoprostol (Study Group)

Experimental group

Description:

In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.

Treatment:

Drug: Misoprostol

No drug

No Intervention group

Description:

In control group no dose will be administered