Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000808842
Ethics application status
Approved
Date submitted
16/11/2020
Date registered
25/06/2021
Date last updated
25/06/2021
Date data sharing statement initially provided
25/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
POMMS: Pre-Operative Misoprostol in Myomectomy Surgery – A Pilot Study
Scientific title
Investigating the Effect of Pre-Operative Misoprostol on Intraoperative Bleeding in Myomectomy Surgery - A Pilot Study
Secondary ID [1] 302808 0
None
Universal Trial Number (UTN)
U1111-1261-2648
Trial acronym
POMMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibroids 319770 0
Condition category
Condition code
Reproductive Health and Childbirth 317703 317703 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319085 0
Treatment: Drugs
Comparator / control treatment
The control group is the placebo group who is administered two similarly shaped dissolvable tablets sublingually. Both the patient and the surgeon is blinded to the intervention. The placebo is a microcellulose capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 325743 0
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).
Timepoint [1] 325743 0
Intraoperative blood loss will be assessed immediately post surgery.

Secondary outcome [1] 388969 0
Change in haemoglobin concentration pre and post surgery

Timepoint [1] 388969 0
Baseline at least 72 hours pre-operatively and >12 hours post operatively
Secondary outcome [2] 388970 0
Operative time assessed via hospital records
Timepoint [2] 388970 0
Duration of operation assessed immediately post operatively
Secondary outcome [3] 388971 0
Blood transfusion assessed as number of packed RBC units as indicated on the patient's medical chart
Timepoint [3] 388971 0
Within the first 24 hours post operatively
Secondary outcome [4] 388973 0
Post operative complications assessed via patient medical records
Timepoint [4] 388973 0
30 days post operatively
Secondary outcome [5] 388974 0
Use of adjuvant measures to reduce blood loss (ie: tranexamic acid) assessed via patient medication chart
Timepoint [5] 388974 0
Immediately post operatively

Eligibility
Key inclusion criteria
• Age 18 years or older
• Planned open or laparoscopic myomectomy
• Patient agreement to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of allergy to misoprostol or prostaglandins
• Contraindications to misoprostol use – pregnancy or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once informed consent is gained, a trial number will be allocated to the participant.
At day of surgery, a computer-automated software will be used to randomly allocate each patient to one of the study arms.

Randomization will be performed using a random number generator and used to produce envelopes allocating patients to either the misoprostol (two 200mcg tablets that dissolve sublingually) or placebo (two similar shaped tablets that dissolve sublingually) treatment arms. This randomization process will be carried out in the pharmacy department and the appropriate medication brought in the specific envelope numbered with the patient trial number. Immediately prior to the patient’s operation this envelope will be given to the theatre staff working in that theatre list in the Day Procedure Unit and they will administer the tablets sublingually to the patient. The patient will be blinded to the arm she was assigned to, as will the surgeons.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed using a random number generator and used to produce envelopes allocating patients to either the misoprostol (two 200mcg tablets that dissolve sublingually) or placebo (two similar shaped tablets that dissolve sublingually) treatment arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
We based our power calculation on previous studies assessing rectal and vaginal administration of misoprostol on intra-operative blood loss at myomectomy surgery. In the misoprostol group we used a mean anticipated blood loss of 500ml +/- 300ml, and in the placebo group we used a mean anticipated blood loss of 700ml using an enrolment ration of 1:1 with a type I error rate of 0.05 (a = 0.05) with a power of 0.8 (ß=0.2) which gives a sample size of 72 – 36 in each study arm.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/09/2018
Date of last participant enrolment
Anticipated
2/07/2021
Actual
Date of last data collection
Anticipated
30/07/2021
Actual
Sample size
Target
72
Accrual to date
53
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18037 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 32014 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 307234 0
Other Collaborative groups
Name [1] 307234 0
Advanced Gynaecological and Endoscopic Surgery (AGES)
Country [1] 307234 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital Human Research and Ethics Committee
Address
19 Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 307839 0
None
Name [1] 307839 0
Address [1] 307839 0
Country [1] 307839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307330 0
Royal Women's Hospital Human Research and Ethics Committee
Ethics committee address [1] 307330 0
19 Flemington Road Parkville Victoria 3052
Ethics committee country [1] 307330 0
Australia
Date submitted for ethics approval [1] 307330 0
30/04/2017
Approval date [1] 307330 0
01/08/2017
Ethics approval number [1] 307330 0
17/07

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106858 0
Dr Lima Wetherell
Address 106858 0
Royal Women's Hospital
19 Flemington Road, Parkville VIC 3052
Country 106858 0
Australia
Phone 106858 0
+61421240243
Fax 106858 0
Email 106858 0
[email protected]
Contact person for public queries
Name 106859 0
Dr Lima Wetherell
Address 106859 0
Royal Women's Hospital
19 Flemington Road, Parkville VIC 3052
Country 106859 0
Australia
Phone 106859 0
+61421240243
Fax 106859 0
Email 106859 0
[email protected]
Contact person for scientific queries
Name 106860 0
Dr Lima Wetherell
Address 106860 0
Royal Women's Hospital
19 Flemington Road, Parkville VIC 3052
Country 106860 0
Australia
Phone 106860 0
+61421240243
Fax 106860 0
Email 106860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9770Study protocol  [email protected]
9771Statistical analysis plan  [email protected]
9772Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePOMMS: Pre-operative misoprostol in myomectomy surgery: A randomised controlled pilot study.2022https://dx.doi.org/10.1016/j.ejogrb.2022.07.008
N.B. These documents automatically identified may not have been verified by the study sponsor.