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Spots Global Cancer Trial Database for Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy

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Trial Identification

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

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

Study ID: NCT05108597

Interventions

Misoprostol

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

PEMH, Rawalpindi, Punjab, Pakistan

Contact Details

Name: Salma Nisar

Affiliation: Resident OBGYN

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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