POMMS: Pre-Operative Misoprostol in Myomectomy Surgery – A Pilot Study
Investigating the Effect of Pre-Operative Misoprostol on Intraoperative Bleeding in Myomectomy Surgery - A Pilot Study
Royal Women's Hospital Human Research and Ethics Committee
72 participants
Sep 28, 2018
Interventional
Conditions
Summary
This randomised controlled double blinded clinical trial assess the impact of sublingual misoprostol on blood loss during myomectomy surgery - both abdominal or laparoscopic. We hypothesis that sublingual misoprostol reduces intraoperative blood loss during myomectomy.
Eligibility
Inclusion Criteria3
- Age 18 years or older
- Planned open or laparoscopic myomectomy
- Patient agreement to participate in the study
Exclusion Criteria2
- History of allergy to misoprostol or prostaglandins
- Contraindications to misoprostol use – pregnancy or breastfeeding
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Interventions
We are looking at whether sublingual misoprostol reduces intraoperative blood loss during myomectomy surgery. This is a randomised controlled double blinded study. It is a two armed study - Arm 1 receives two 200mcg misoprostol tablets sublingually within 30 minutes of surgery Arm 2 receives two similarly shaped placebo tablets sublingually within 30 minutes prior to abdominal or laparoscopic myomectomy. Blood loss is measured in all patients as well pre and post-operative haemoglobin. Adherence to the intervention will be monitored by tracking of empty placebo/misoprostol bottles returned back to pharmacy empty.
Locations(1)
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ACTRN12621000808842