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

Blood Loss, Surgical Clinical Trial

Official title:

Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108597
• Other study ID #: 25102021
• Status: Completed
• Phase: Phase 3
• Start date: March 4, 2019
• Est. completion date: March 4, 2020

Study information

• Verified date: October 2021
• Source: Pak Emirates Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Leiomyoma
• Uterine Myoma

Intervention

Drug:
• Misoprostol
400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy

Locations

Country	Name	City	State
Pakistan	PEMH	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pak Emirates Military Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss	Intraoperative blood loss will be recorded by a trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.	During the surgical procedure