Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103517062817 Date of Approval: 16/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title REDUCING BLOOD LOSS DURING ABDOMINAL MYOMECTOMY: SUBLINGUAL MISOPROSTOL WITH PERICERVICAL TOURNIQUET VERSUS PERICERVICAL TOURNIQUET ALONE; A RANDOMIZED CONTROL TRIAL
Official scientific title REDUCING BLOOD LOSS DURING ABDOMINAL MYOMECTOMY: SUBLINGUAL MISOPROSTOL WITH PERICERVICAL TOURNIQUET VERSUS PERICERVICAL TOURNIQUET ALONE; A RANDOMIZED CONTROL TRIAL
Brief summary describing the background and objectives of the trial To compare the effect of a single preoperative dose of 400microgram of sublingual misoprostol plus pericervical tourniquet with a pericervical tourniquet alone in reducing intraoperative blood loss during abdominal myomectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Surgery
Sub-Disease(s) or condition(s) being studied UTERINE FIBROIDS
Purpose of the trial Prevention
Anticipated trial start date 29/04/2019
Actual trial start date 15/07/2019
Anticipated date of last follow up 28/10/2019
Actual Last follow-up date 28/02/2020
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 68
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo with pericervical tourniquet Two tablets of sublingual placebo (inert, identical to misoprostol in shape, colour and size) One dose 15 minutes before surgery The patients received two tablets of placebo (inert, identical to misoprostol in shape, colour and size) placed under their tongue 15 minutes before abdominal myomectomy. The patients also had a pericervical tourniquet at surgery. 34 Placebo
Experimental Group Misoprostol with pericervical tourniquet 400 micrograms 15 minutes before surgery The patients received two tablets of misoprostol (each 200 micrograms) placed under their tongue 15 minutes before abdominal myomectomy. The patients also had a pericervical tourniquet at surgery 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging. 2. Age > 18years. 3. Pre-menopausal women 4. Pre-operative hematocrit >30% 5. Women willing to have sublingual administration of misoprostol or a placebo pre-procedure. 6. No other pre-operative medical intervention to reduce blood loss during abdominal myomectomy. 7. Consultant-led Abdominal myomectomy. 8. Regional anaesthesia for Abdominal myomectomy 9. Ability to understand and the willingness to sign a written informed consent. 1. Patients who have had a prior abdominal myomectomy 2. Post-menopausal women 3. Patients with a history of gynecologic malignancy 4. Patients with known bleeding/clotting disorders 5. Patients on anticoagulant therapy. 6. History of allergic reactions attributed to misoprostol or compounds of similar chemical or biologic composition to misoprostol Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/06/2019 UIUCH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University College Hospital, Queen Elizabeth Road, Mokola, Ibadan Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood loss at abdominal myomectomy At sugery
Secondary Outcome Need for blood transfusion Post operative period
Secondary Outcome Post operative haematocrit 24 hours after surgery
Secondary Outcome Duration of surgery At surgery
Secondary Outcome Febrile morbidity within 24 hours of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth road Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Adebayo Agboola Department of Obstetrics and Gynaecology, University College Hospital, Queen Elizabeth Road, Mokola Ibadan Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adebayo M.D. Agboola University College Hospital, Queen Elzabeth Road Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Olutosin Awolude Department of Obstetrics and Gynaecology, University College Hospital, Queen Elizabeth Road Ibadan Nigeria
Professor Oladosu Ojengbede Department of Obstetrics and Gynaecology, University College Hospital, Queen Elizabeth Road Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adebayo Agboola agboolamd123@gmail.com +2348124665856 Department of Obstetrics and Gynaecology, University College Hospital, Queen Elizabeth Road
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Oluwatosin Awolude tosinawolude@yahoo.com +2348032222986 Department of Obstetrics and Gynaecology, University College Hospital, Queen Elizabeth Road
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Oladosu Ojengbede ladosu2002@yahoo.co.uk +2348034426047 Department of Obstetrics and Gynaecology, University College Hospital, Queen Elizabeth Road
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices) may be shared with the appropriate consent Clinical Study Report,Study Protocol within 2 years Controlled access including participants who give consent
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information