POMMS: Pre-Operative Misoprostol in Myomectomy Surgery – A Pilot Study
Phase 4
Recruiting
- Conditions
- FibroidsReproductive Health and Childbirth - Other reproductive health and childbirth disorders
- Registration Number
- ACTRN12621000808842
- Lead Sponsor
- Royal Women's Hospital Human Research and Ethics Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 72
Inclusion Criteria
•Age 18 years or older
•Planned open or laparoscopic myomectomy
•Patient agreement to participate in the study
Exclusion Criteria
•History of allergy to misoprostol or prostaglandins
•Contraindications to misoprostol use – pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is assess the effect of pre-operative sublingual misoprostol on intraoperative blood loss during myomectomy surgery – open or laparoscopic. This will be measured by the volume of blood in the suction canister at the conclusion of surgery and/or the number of packs used (weighed). [Intraoperative blood loss will be assessed immediately post surgery. <br><br>]
- Secondary Outcome Measures
Name Time Method Change in haemoglobin concentration pre and post surgery <br><br>[Baseline at least 72 hours pre-operatively and >12 hours post operatively ];Operative time assessed via hospital records [Duration of operation assessed immediately post operatively ];Blood transfusion assessed as number of packed RBC units as indicated on the patient's medical chart [Within the first 24 hours post operatively ];Post operative complications assessed via patient medical records [30 days post operatively ];Use of adjuvant measures to reduce blood loss (ie: tranexamic acid) assessed via patient medication chart [Immediately post operatively ]