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

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 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