RecruitingPhase 4ACTRN12621000808842

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


Sponsor

Royal Women's Hospital Human Research and Ethics Committee

Enrollment

72 participants

Start Date

Sep 28, 2018

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Uterine fibroids are non-cancerous growths in the uterus that can cause heavy bleeding, pain, and pressure symptoms. When fibroids need to be surgically removed — a procedure called myomectomy — one of the main risks is blood loss during the operation. This study is testing whether misoprostol, a medication given under the tongue just before surgery, can reduce bleeding during myomectomy. Misoprostol causes the uterus to contract, which may help limit blood flow to the fibroid and reduce intraoperative blood loss. Participants are randomly assigned to receive either misoprostol or a placebo before their surgery, and neither the patient nor the surgeon knows which was given until after the study. You may be eligible if you are a woman aged 18 or older who is scheduled for either an open (abdominal) or laparoscopic (keyhole) myomectomy and agree to take part. Women with an allergy to misoprostol or prostaglandins, or who are pregnant or breastfeeding, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 rece

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)

The Royal Women's Hospital - Parkville

VIC, Australia

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ACTRN12621000808842