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.: PACTR202607696756780 Date of Registration: 14/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between bilateral uterine artery ligation and temporary tourniquet application for controlling blood loss during surgical management of placenta previa major with suspected placenta accreta spectrum
Official scientific title A prospective randomized controlled trial comparing temporary tourniquet application versus bilateral uterine artery ligation for reducing intraoperative blood loss during surgical management of placenta previa major with suspected placenta accreta spectrum
Brief summary describing the background and objectives of the trial Placenta previa major with suspected placenta accreta spectrum is associated with significant intraoperative hemorrhage and increased maternal morbidity. Several surgical techniques have been introduced to reduce blood loss during cesarean delivery, including temporary tourniquet application and bilateral uterine artery ligation. However, evidence comparing the efficacy of these two techniques remains limited. This prospective randomized controlled trial aims to compare temporary tourniquet application with bilateral uterine artery ligation regarding intraoperative blood loss, blood transfusion requirements, operative time, need for hysterectomy, postoperative complications, and maternal outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TUL-PAS Trial
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Placenta previa major with suspected placenta accreta spectrum
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2026
Actual trial start date
Anticipated date of last follow up 01/07/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Temporary tourniquet application Single intraoperative procedure Applied during cesarean delivery until adequate hemostasis is achieved After delivery of the fetus and cord clamping, a sterile Foley catheter or vascular tape will be temporarily applied around the lower uterine segment to reduce uterine blood flow during surgical management of placenta previa major with suspected placenta accreta spectrum. The tourniquet will be removed after completion of the surgical procedure and achievement of adequate hemostasis. 30
Control Group Bilateral uterine artery ligation Single intraoperative procedure Performed during cesarean delivery After delivery of the fetus and cord clamping, bilateral uterine artery ligation will be performed at the level of the cervico-uterine junction to reduce uterine blood flow and control intraoperative bleeding during surgical management of placenta previa major with suspected placenta accreta spectrum. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women aged 18 years or older. Gestational age ≥34 weeks. Singleton pregnancy. Placenta previa major diagnosed by ultrasonography. Suspected placenta accreta spectrum based on ultrasound with or without MRI. Planned elective cesarean delivery. Ability and willingness to provide written informed consent Emergency cesarean section due to uncontrolled hemorrhage. Confirmed placenta percreta with planned cesarean hysterectomy. Known coagulation or bleeding disorders. Multiple pregnancy. Major fetal congenital anomalies or intrauterine fetal demise. Severe maternal medical illness contraindicating study participation. Refusal to participate in the study. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 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
No 08/07/2026 Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Minia University Minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Estimated intraoperative blood loss (mL) Measured intraoperatively from skin incision until completion of surgery.
Secondary Outcome Requirement for blood transfusion (number of packed red blood cell units transfused) During surgery and within the first 24 hours postoperatively.
Secondary Outcome Operative time (minutes) Measured intraoperatively from skin incision to skin closure.
Secondary Outcome Postoperative hemoglobin change (g/dL) Measured 24 hours after surgery.
Secondary Outcome Need for cesarean hysterectomy Assessed during surgery.
Secondary Outcome Maternal intraoperative and postoperative complications (bladder injury, ureteric injury, ICU admission, postoperative infection) Assessed during surgery and until hospital discharge.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University Hospital for Obstetrics and Gynecology Minia University Minia 61519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hossam Rabie Minia, Egypt Minia 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Minia University Faculty of Medicine, Minia University Minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam Rabie hossamrabie22@gmail.com +201025241128 Faculty of Medicine, Minia University,
City Postal code Country Position/Affiliation
Minia 61519 Egypt Resident of Obstetrics and Gynecology Faculty of Medicine Minia University
Role Name Email Phone Street address
Public Enquiries Hossam Rabie hossamrabie22@gmail.com +201025241128 Faculty of Medicine, Minia University
City Postal code Country Position/Affiliation
Minia 61519 Egypt Resident of Obstetrics and Gynecology Faculty of Medicine Minia University
Role Name Email Phone Street address
Scientific Enquiries Hossam Rabie hossamrabie22@gmail.com +201025241128 Faculty of Medicine, Minia University
City Postal code Country Position/Affiliation
Minia 61519 Egypt Resident of Obstetrics and Gynecology Faculty of Medicine Minia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available upon reasonable request to the principal investigator after publication of the primary results. Study Protocol Data will be available from 12 months after publication of the primary results for up to 5 years. Access will be provided to qualified researchers upon reasonable request, subject to approval by the principal investigator and the Research Ethics Committee.
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
Funding Source FundingSources List 07/07/2026 Changed the funding source name to the actual funder (Principal Investigator) as requested by the reviewer. Self funded, Minia, Egypt , Minia , 61519, Egypt, Self Funded, Hossam Rabie, Minia, Egypt , Minia , 61519, Egypt, Self Funded,