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.: PACTR201811625172526 Date of Approval: 29/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title temporary uterine artery clamping in cesarean section
Official scientific title The evaluation of the efficiency of temporary uterine artery clamping on postpartum hemorrhage in cesarean section.
Brief summary describing the background and objectives of the trial Cesarean section is a common and bleeding procedure in world wide. Because of the blood lose, hematocrit and hemoglobin levels decrease after cesarean section. The aim of this study was to evaluate the change in preoperative and postoperative hemoglobin, hematocrit and hemorrhage by temporary uterine artery clamping after the newborn delivery in cesarean operation.
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 postpartum hemorrhage
Purpose of the trial Prevention
Anticipated trial start date 26/11/2018
Actual trial start date 27/11/2018
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental Group 6 months In the primary cesarean sections, after delivery of the newborn, the uterus will be taken outside the abdomen and bilateral uterine arteries will be clamped with atraumatic intestinal clamps in the case group. In the control group with similar characteristics, no clamp will be placed. The placenta will then be removed and the uterine incision will be closed. Preoperative and postoperative homoglobin and homatokrit levels will be studied and recorded. With the aid of vacuum aspirator during the cesarean section, all bleeding will be collected and then measured. Amniotic fluid will not be aspirated. After the uterine incision is closed, clamps will be removed. All demographic data, hemoglobin and hematocrit levels, additional suture need for uterine incision, duration of operation, duration of discharge, need for total painkiller, maternal and neonatal complications will be recorded in both groups. 100
Control Group Control Group 6 months In the primary cesarean sections, after delivery of the newborn, the uterus will be taken outside the abdomen and bilateral uterine arteries will be clamped with atraumatic intestinal clamps in the case group. In the control group with similar characteristics, no clamp will be placed. The placenta will then be removed and the uterine incision will be closed. Preoperative and postoperative homoglobin and homatokrit levels will be studied and recorded. With the aid of vacuum aspirator during the cesarean section, all bleeding will be collected and then measured. Amniotic fluid will not be aspirated. After the uterine incision is closed, clamps will be removed. All demographic data, hemoglobin and hematocrit levels, additional suture need for uterine incision, duration of operation, duration of discharge, need for total painkiller, maternal and neonatal complications will be recorded in both groups. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Primary singleton cesarean sections 2.BMI<35 kg/m2 3.Between 37-42 weeks pregnancy 4.Between 18-40 ages 5.No any maternal systemic disorders. 1. Multiple pregnancy 2. Pregnacy plus myoma utery 3. Polyhydramnios 4. Pregnant women with chorioamnionitis 5. Pregnant women with placental abnormalities 6. Pregnant women with bleeding diathesis 7. Pregnant women with low platelet 8. Women who do not want to participate 9. Women who have previous history of postpartum hemorrhage 10. Women with severe adhesion in operation 11.Women with multiparity Adult: 19 Year-44 Year 18 Year(s) 40 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 28/10/2018 Mogadishu Somali Turkey Recep Tayyip Erdogan Education and Research Hospital Etical Committe
Ethics Committee Address
Street address City Postal code Country
Recep Tayyip Erdogan Street Mogadishu 123456 Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Preoperative and postoperative hemoglobin, hematocrit and bleeding amount will be measured and recorded. The effects of uterine artery clamping on these variables are examined. during cesarean section
Secondary Outcome It will be investigated that the effect of bilateral temporary uterine artery clamping on postpartum hemorrhage in our study. from cesarean section to 45th day postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mogadishu Somali Turkey Recep Tayyip Erdogan Education and Research Hospital Recep Tayyip Erdogan Street Mogadishu Somalia
FUNDING SOURCES
Name of source Street address City Postal code Country
MOGADISHU SOMALI TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL RECEP TAYYIP ERDOGAN STREET, MOGADISHU SOMALI-TURKEY RECEP TAYYIP ERDOGAN EDUCATION AND RESEARCH HOSPITAL MOGADISHU 12345 Somalia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mogadishu Somali Turkey Recep Tayyip Erdogan Education and Research Hospital Recep Tayyip Erdogan Street Mogadishu Somalia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Recep Erin erinrecep@gmail.com +905335629874 mogadishu somali-turkey recep tayyip erdogan education and research hospital
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Scientific Enquiries AHMED ISHAK HUSSEIN daacat100@gmail.com +252615597479 mogadishu somali-turkey recep tayyip erdogan education and research hospital
City Postal code Country Position/Affiliation
Mogadishu Somalia Dr.
Role Name Email Phone Street address
Public Enquiries Safiya Sagal Ahmed safiyosagal40@gmail.com +252615937497 mogadishu somali-turkey recep tayyip erdogan education and research hospital
City Postal code Country Position/Affiliation
Mogadishu Somalia Miss
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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