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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607873538129 Date of Registration: 24/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rectal misoprostol versus intravenous tranexamic acid as an adjunct to tourniquet during abdominal myomectomy: A randomized controlled trial
Official scientific title Rectal misoprostol versus intravenous tranexamic acid as an adjunct to tourniquet during abdominal myomectomy: A randomized controlled trial
Brief summary describing the background and objectives of the trial Uterine fibroids are the most common non-cancerous growths in the female reproductive system worldwide. Abdominal myomectomy remains a key fertility-preserving surgical option for women with symptomatic uterine fibroids, particularly in resource-limited settings. However, significant intraoperative blood loss is a major complication that often necessitates blood transfusion and increases perioperative morbidity. Therefore, implementing strategies to minimize bleeding during myomectomy is essential to reducing the associated morbidity and mortality and ultimately improving patient outcomes. Application of tourniquets to occlude the peri-cervical uterine arteries have been used to reduce intra-operative blood loss, however adjunctive pharmacological agents such as misoprostol or tranexamic acid (TXA) have been noted to further enhance hemostasis, reduce operative morbidity and improve surgical outcomes. While both agents are individually effective when used in combination with tourniquets, there are limited available data or fewer studies directly comparing the efficacy and safety of these agents when used as an adjunct during myomectomy. This study aims to generate comparative data on the effectiveness and safety of two widely available and cost-effective pharmacological agents, potentially guiding clinical decision-making in minimizing blood loss during 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
Sub-Disease(s) or condition(s) being studied BENIGN UTERINE TUMOUR- UTERINE FIBROIDS
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2026
Actual trial start date
Anticipated date of last follow up 31/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 106
Actual target sample size (number of participants) 106
Recruitment status Not yet recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intravenous Tranexamic acid 1000mg Administered thirty minutes before surgery Tranexamic acid is an anti-fibrinolytic agent which works by reversibly inhibiting the activation of plasmin and preventing breakdown of fibrin in blood clots. This stabilizes blood clots, thus reducing excessive bleeding during surgery without impairing coagulation cascade. 53 Active-Treatment of Control Group
Experimental Group Rectal misoprostol 400mcg Administered 1hour before surgery Misoprostol is a prostaglandin E1 analogue which is widely used in obstetrics for the treatment and prevention of postpartum haemorrhage, may decrease intra-operative bleeding in abdominal myomectomies. 53
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women diagnosed of uterine fibroid and scheduled for abdominal myomectomy No previous history of myomectomy or pelvic surgery No chronic medical disorder such as diabetes, hypertension, pulmonary or cardiac diseases No previous history of allergy or adverse drug reaction to misoprostol or tranexamic acid (TXA) Non-consenting eligible patient with uterine fibroid scheduled for myomectomy Patients with medical disorders like hypertension, diabetes, pulmonary or cardiac disorder Allergic to misoprostol or tranexamic acid Previous myomectomy or pelvic surgery Patient receiving preoperative hormonal therapy: example GnRH analogues Haemoglobin less than 10mg/dl Pregnancy Adenomyosis History of bleeding disorder or coagulopathy Adult: 18 Year(s)-44 Year(s),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 10/07/2026 RESEARCH ETHICS COMMITTE
Ethics Committee Address
Street address City Postal code Country
UNIOSUN TEACHING HOSPITAL, OSOGBO, OSUN STATE, NIGERIA OSOGBO 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraoperative estimated blood loss (EBL) will be measured using both gravimetric and volumetric method immediate postoperative
Secondary Outcome Change in the haematocrit (Hct) from preoperative baseline to 24hours post-operative Need for blood transfusion: number of patients receiving intra-operative or postoperative transfusion and the total units of blood transfused per patient Operative time: from skin incision to closure of the skin (mins) Length of hospital stay Adverse drug reaction vis-à-vis nausea, vomiting,diarrhoea, fever, chills and rigor, thromboembolic event, allergic reaction and seizure 48hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIOSUN Teaching Hospital Idi-Seke, Area Osogbo 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ojo John Oluwadamilola Idi-Seke, Area Osogbo 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. John Oluwadamilola OJO Department of Obstetrica and Gynaecology, UNIOSUN Teaching Hospital Osogbo 23401 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John OJO johnoluwadamilola1@gmail.com 2347030105089 No1 Fatoki Estate
City Postal code Country Position/Affiliation
Osogbo 23401 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries SEKINAH BOLAOYEBAMIJI sbolaoyebamiji@gmail.com +2348033238808 SP HOSPITAL, BEHIND GOF INTERNATIONAL SCHOOL, OGO-OLUWA
City Postal code Country Position/Affiliation
OSOGBO 23401 Nigeria HONORARY CONSULTANT
Role Name Email Phone Street address
Public Enquiries DANIEL ADEKANLE adekanled@gmail.com +2348035379325 COLLEGE OF HEALTHSCIENCES, UNIOSUN
City Postal code Country Position/Affiliation
OSOGBO 23401 Nigeria PROFESSOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will committed to transparent research and plan to share de-identified individual participant data (IPD) collected during this trial. The shared dataset will include baseline demographics and all primary and secondary clinical outcomes—specifically, estimated blood loss, perioperative haematocrit levels, transfusion requirements, and any recorded adverse events. To fully contextualize the data, I will also provide the full study protocol, the Statistical Analysis Plan (SAP), and the blank Informed Consent Form (ICF). This data package will be made available 1year following the publication of our primary results (giving our team time to finalize secondary analyses) and will remain accessible for a period of 3 years. Informed Consent Form,Study Protocol 1year to 2years post publication To protect participant privacy, data access is strictly controlled. Here is how we manage requests: Who can apply: Access is reserved exclusively for qualified researchers affiliated with recognized academic, clinical, or public health institutions. Allowed uses: The data may only be used for methodologically sound secondary research, such as verifying our primary outcomes or incorporating the data into larger systematic reviews and meta-analyses. Commercial use, unapproved post-hoc analyses, or any attempt to re-identify participants is strictly prohibited. The request process: Interested researchers must submit a formal proposal detailing their scientific hypothesis and analysis plan. This proposal will be evaluated by our study's Data Access Committee (including the PI, a biostatistician, and an ethics representative) for scientific merit. Final requirements: Before any data is securely transferred, approved applicants must provide proof of independent ethical (IRB/HREC) approval for their specific analysis and sign a legally binding Data Use Agreement (DUA) to ensure strict adherence to data protection laws.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 17/07/2026 lower case recommended by the reviewer RECTAL MISOPROSTOL VERSUS INTRAVENOUS TRANEXAMIC ACID AS AN ADJUNCT TO TOURNIQUET DURING ABDOMINAL MYOMECTOMY: A RANDOMIZED CONTROLLED TRIAL Rectal misoprostol versus intravenous tranexamic acid as an adjunct to tourniquet during abdominal myomectomy: A randomized controlled trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 17/07/2026 lower case recommended by the review RECTAL MISOPROSTOL VERSUS INTRAVENOUS TRANEXAMIC ACID AS AN ADJUNCT TO TOURNIQUET DURING ABDOMINAL MYOMECTOMY: A RANDOMIZED CONTROLLED TRIAL Rectal misoprostol versus intravenous tranexamic acid as an adjunct to tourniquet during abdominal myomectomy: A randomized controlled trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 17/07/2026 Because the initial proposed date has passed 01 Jul 2026 01 Aug 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 17/07/2026 Not applicable 106
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 17/07/2026 Just added the name of the sponsor Self funded, Idi-Seke, Area, Osogbo, 23401, Nigeria, Self Funded, Ojo John Oluwadamilola, Idi-Seke, Area, Osogbo, 23401, Nigeria, University,