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.: PACTR202303468069055 Date of Approval: 15/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of combined vaginal misoprostol and tourniquet or tourniquet alone on reducing blood loss during abdominal myomectomy.
Official scientific title The effect of combined vaginal misoprostol and tourniquet or tourniquet alone on reducing blood loss during abdominal myomectomy.
Brief summary describing the background and objectives of the trial Blood loss during abdominal myomectomy is an important complication that can negatively impact on the post-operative recovery and quality of life of women undergoing this procedure. The main objective of this study was to determine the reduction in blood loss when a single pre-operative dose of 600ug vaginal misoprostol plus peri-cervical tourniquet was compared with peri-cervical tourniquet alone during abdominal myomectomy, using changes in pre-operative and post-operative hemoglobin levels as a surrogate measure of blood loss. Secondary outcomes of the study included the need for blood transfusion, adverse effects of misoprostol, duration of surgery, febrile morbidity and length of hospital stay.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Primary haemorrhage during myomectomy
Purpose of the trial Education /Training
Anticipated trial start date 12/04/2021
Actual trial start date 12/04/2021
Anticipated date of last follow up 01/12/2021
Actual Last follow-up date 01/12/2021
Anticipated target sample size (number of participants) 133
Actual target sample size (number of participants) 80
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vaginal misoprostol plus pericervicl tourniquet 600ug misoprostol an hour prior to surgery vaginal misoprostol plus peri-cervical tourniquet during surgery 40
Control Group pericervical tourniquet during surgery tourniquet tied around base of broad ligament during surgery to occlude uterine and ovarian vessels. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All reproductive-aged women with symptomatic fibroids who desire future fertility Uterine size not exceeding 28 weeks gestation on abdominal examination All women with symptomatic uterine fibroids who give voluntary consent tp partake in the study Parous reproductive-aged women with symptomatic fibroids and no future fertility wishes Peri-menopausal women with symptomatic fibroids who do not desire fertility Women with hemoglobin level less than 10g/dl before surgery Women with prior abdominal surgeries including Cesarean section and previous myomectomy Women with body mass index greater than 35kg/m2, due to surgical challenges Women who refuse blood transfusion Women with hemoglobinopathies and coagulation disorders Women with co-existing chronic medical conditions Women who have allergies to prostaglandins Women with symptoms suggestive of Covid-19 and who test positive for the virus within two weeks prior to surgery Adult: 19 Year-44 Year 23 Year(s) 47 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 25/09/2020 37 Military Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Neghelli Barracks Accra 0233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome To determine the need for intraoperative or post-operative blood transfusion for women in both the treatment and the control groups. To assess the prevalence of adverse effects of misoprostol in the treatment group. To assess the differences in post-operative febrile morbidity, surgery duration and length of hospital stay in both the treatment and control groups during surgery and 3 days post surgery
Primary Outcome To determine the reduction in blood loss using pre-operative and post-operative hemoglobin changes between women in the treatment and control groups 24 hours before and 24hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
37 Military Hospital Neghelli Barracks Accra 0233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Deliverance Agyabeng Neghelli Barracks Accra 00233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Deliverance Agyabeng Neghelli Barracks Accra 0233 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Deliverance Agyabeng d6ps23@yahoo.com 0233540350228 Esther Ocloo street
City Postal code Country Position/Affiliation
Accra 0233 Ghana Senior Resident. Obstetric and Gynecology Department. 37 Military Hospital
Role Name Email Phone Street address
Public Enquiries Prince Ashitey pyashitey@yahoo.com 00233243004247 Neghelli Barracks
City Postal code Country Position/Affiliation
Accra 0233 Ghana Administration officer
Role Name Email Phone Street address
Scientific Enquiries Thomas Ndanu revtomdata@gmail.com 0233244872410 Korle-Bu
City Postal code Country Position/Affiliation
Accra 0233 Ghana Statistician. University of Ghana Dental School
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A single preoperative dose of vaginal misoprostol (600µg) plus peri-cervical tourniquet is a simple and effective method of significantly reducing blood loss during abdominal myomectomy when uterine size is ≥ 18 weeks compared to the use of peri-cervical tourniquet alone. There was, however, no significant difference as regards the need for intraoperative or postoperative blood transfusion between the two groups. Additionally, this dosage of misoprostol did not result in any appreciable increase in the adverse effects of the drug and there was no difference in febrile morbidity, duration of surgery and length of hospital stay when tourniquet is used alone or combined with misoprostol. Clinical Study Report 1 year Access will be granted to all academics who are interested in research, Process of requesting for data will be decided by principal investigator and the criteria for reviewing requests will be based on quality of request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 14/03/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 14/03/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information