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.: PACTR201802003039106 Date of Approval: 02/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of reduction of blood loss at myomectomy using Misoprostol to that of Haemostatic Torniquet
Official scientific title Comparing Perioperative Vaginal Misoprostol With Intraoperative Pericervical Haemostatic Tourniquet In Reducing Blood Loss During Abdominal Myomectomy
Brief summary describing the background and objectives of the trial Background: Myomectomy is often the preferred surgical option for symptomatic uterine fibroids in women who desire to retain their uterus. However, blood loss at abdominal myomectomy is often significant and may lead to devastating complications. AIM: To compare the effectiveness of perioperative administration of vaginal misoprostol to intra-operative pericervical haemostatic tourniquet in reducing blood loss during abdominal myomectomy at University of Ilorin Teaching Hospital, Ilorin. OBJECTIVES: 1.To estimate the blood loss among patients in groups I and II. 2.To compare the differences in the pre-operative and post-operative haematocrit of patients in both groups. 3.To compare the need for blood transfusion in both groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Uterine Fibroid
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/06/2016
Actual trial start date 31/05/2017
Anticipated date of last follow up 07/06/2017
Actual Last follow-up date 12/06/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ERCPAN/2015/09/1455 Ethical Review Committee of the University of Ilorin Teaching Hospital , Ilorin, Nigeria
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Perioperative Vaginal Misoprostol 400 microgram One hour before commencement of surgery vaginal Misoprostol 40
Control Group Pericervical Haemostatic Torniquet Not applicable Not more than 45 minutes before release Intraoperative 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosis of uterine fibroid with a treatment plan for abdominal myomectomy Exclusion criteria: 1.Known allergy to prostaglandins including misoprostol. 2.Chronic medical disorders including hypertension, diabetes mellitus, cardiac or pulmonary diseases. 3.Previous uterine surgery (myomectomy or caesarean section). 4.Known bleeding or clotting disorders. 5.Haematocrit at 24hours before surgery less than 30%. 6.Patient refusal to participate in the study. 20 Year(s) 48 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 10/09/2015 Ethical Review Committee of the University of Ilorin Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke-Oyi Ilorin Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intra-operative blood loss and Need for intra-operative blood transfusion. Intraoperative period (not more than 3 hours)
Secondary Outcome 1. Occurrences of side effects of Misoprostol including nausea, vomiting, diarrhoea, shivering and elevated temperature (temperature ¿ 380C). 2. Need for hysterectomy. 3. Post-operative haematocrit. 4. Need for post-operative blood transfusion. Up to 24 hours post operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital Old Jebba Road, Oke- Oyi Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Ilorin Teaching Hospital Old Jebba Road, Oke- Oyi Ilorin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Ilorin Teaching Hospital Old Jebba Road, Oke- Oyi Ilorin Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr M.A. AFOLABI University of Ilorin Teaching Hospital, Old Jebba Road, Oke- Oyi Ilorin Nigeria
Dr G.G. EZEOKE University of Ilorin Teaching Hospital, Old Jebba Road, Oke- Oyi Ilorin Nigeria
DR R. SAIDU University of Ilorin Teaching Hospital, Old Jebba Road, Oke- Oyi Ilorin Nigeria
DR A.S. ADENIRAN University of Ilorin Teaching Hospital, Old Jebba Road, Oke- Oyi Ilorin Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MUHIBAT AFOLABI muhibatafolabi@yahoo.com +234803 819 3027 Old Jebba Road
City Postal code Country Position/Affiliation
Ilorin Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries MUHIBAT AFOLABI muhibatafolabi@yahoo.com +234803 819 3027 Old Jebba Road
City Postal code Country Position/Affiliation
Ilorin Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries ABIODUN ADENIRAN acrowncord@hotmail.com +234805 753 4788 Old Jebba Road
City Postal code Country Position/Affiliation
Ilorin Nigeria CONSULTANT
REPORTING
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