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.: PACTR201707002372422 Date of Approval: 23/06/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Management of third stage of labour
Official scientific title Intraumbalical vein versus intravenous oxytocin injection for mangment the third stage of labor: A Randomized controlled trial
Brief summary describing the background and objectives of the trial Active management of the third stage of labor, which includes prophylactic injection of 10 international units oxytocin within 2 minutes of birth, early clamping of the umbilical cord, and controlled cord traction, is recommended by the World Health Organizationfor postpartum hemorrhage prevention. Umbilical vein oxytocin injection directs treatment to the placental bed and uterine wall, resulting in earlier uterine contraction and placental separation However, limited published literature is available evaluating the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor Objectives The aim of this study is to evaluate the use of intraumbilical vein injection of oxytocin versus intravenous injection of oxytocin with active management of the third stage of labor in reducing blood loss and length of the third stage
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied managment of tird stage of labour,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2017
Actual trial start date
Anticipated date of last follow up 29/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
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 randomisation using a randomisation table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group intraumblical vein oxytocin injection for management of 3rd stage of labour 10 units oxytocin once after cord clamping immediatly after delivery of the baby after cord clamping immediately after delivery of the baby ..Study group ( A) - patients of this group will receive intraumbilical vein oxytocin 10 units of oxytocin diluted in 10 ml of normal saline) in the umbilical vein proximal to the site of umbilical cord clambing. Control group ( B) - patients of this group will receive10 units of oxytocin intravenous infusion immediately after deliver 200 Active-Treatment of Control Group
Control Group intraumblical vein oxytocin injection for management of 3rd stage of labour 10 units oxytocin once after cord clamping immediatly after delivery of the baby after cord clamping immediately after delivery of the baby ..Study group ( A) - patients of this group will receive intraumbilical vein oxytocin 10 units of oxytocin diluted in 10 ml of normal saline) in the umbilical vein proximal to the site of umbilical cord clambing. Control group ( B) - patients of this group will receive10 units of oxytocin intravenous infusion immediately after deliver 200 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women for normal vaginal delivarywith low risk of post partum hemorrhage, Gestational age; 37 to 41 weeks Parity; PG,,P1-P4 singleton pregnancy Presentation; alive fetus with cephalic Birth weight;2500 to 3500gr placenta; anterior, posterior, fundal All women with high risk for post partum hemorrhage ;-All maternal medical diseases as Hypertensive disorders,diabetes, cardiac disorders,anemia -Placentaprevia -Placenta abruption -Historyofbleeding after delivery in previous pregnancy -history of curettage or cesarean delivery or uterinescar, 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 12/06/2017 Assuit university . faculty of medicine . Medical Ethics Committe
Ethics Committee Address
Street address City Postal code Country
faculty Assuit 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the amount of blood loss in the third and fourth stages of labor.2-duration of the third stage of labor during delivery of the placenta
Secondary Outcome 1-the incidences of postpartum hemorrhage(500 mL or greater), severe postpartum hemorrhage (1,000 mL or greater), 2- percentage of retained placenta two hour after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Manfalout hospital of reproductive health manfalout Assuit 71515 Egypt
women health Hospital of Assuit University Assuit University Assuit 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicie . Assuit University Assuit University Assuit 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicie . Assuit University Assuit University Assuit 71515 Egypt University
COLLABORATORS
Name Street address City Postal code Country
women health hospital , Assuit University Assuit University Assuit 71515 Egypt
Manfalout hospital of reproductive health manfalout Assuit 71515 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shymaa shehata shymaashehata106@gmail.com 01065747161 taqseem alhqoqueen
City Postal code Country Position/Affiliation
Assuit 71515 Egypt resident
Role Name Email Phone Street address
Public Enquiries Ahmed Abdel Aleem aboaliabdelaleem@gmail.com 01001085865 women health hospital of assuit university
City Postal code Country Position/Affiliation
Assuit 71515 Egypt lecturer of obestetiic and gynacology faculty of medicine Assuit university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Alaa Eldin Mahmoud youssef alaayoussef@yahoo.com 01224785272 women health hospital of assuit university
City Postal code Country Position/Affiliation
Assuit 71515 Egypt prof
REPORTING
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