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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000808842

Acronym

POMMS

Enrollment

Registered

2021-06-25

Start date

2018-09-28

Completion date

2021-07-02

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results