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.: PACTR201510001295348 Date of Approval: 05/10/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title passive leg rising in prevention post-spinal hypotension
Official scientific title The role of passive leg rising in prevention post-spinal hypotension in cesarean section: a randomized controlled trial
Brief summary describing the background and objectives of the trial Maternal hypotension is a common complication after subarachnoid block (SAB) for cesarean section (CS). Many measures have been used to prevent and manage maternal hypotension during CS such as fluid preloading, co-loading, colloid using, positioning, and vasopressor administration. Passive leg raising (PLR) creates a transient increase in the preload via translocation of venous blood from the lower limbs to the thorax. PLR has been extensively used for detection of fluid responsiveness in patients with acute circulatory failure.In this study we will examine the possible role for PLR after preforming SAB in prevention of maternal hypotension during CS
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,prevention of spinal induced hypotension in cesarean section,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2015
Actual trial start date 01/11/2015
Anticipated date of last follow up 01/02/2016
Actual Last follow-up date 01/02/2016
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group: supine position with left lateral tilt non till end of surgery Control group: supine position with left lateral tilt 75 Active-Treatment of Control Group
Experimental Group PLR group: passive leg raising 300 till skin incision non till skin incision PLR group: passive leg raising 300 till skin incision 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II, 18 ¿ 40 years old, full term singleton parturients for elective CS under Spinal anesthesia history of cardiovascular diseases, hypertensive disorders of pregnancy, obese patients (BMI>30) 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 17/10/2015 cairo university, faculty of medicine
Ethics Committee Address
Street address City Postal code Country
kasr alainy st cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome number of episodes of hypotension. throughout the procedure
Secondary Outcome ABP, heat rate, nausea and vomiting, total ephedrine requirements, number of episodes of bradycardia, blood loss, urine output, age, and weight. throughout the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University hospitals Kasr Al ainy St Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University hospitals, faculty of medicine Kasr Al ainy St Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University hospitals, faculty of medicine Kasr Al ainy St Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Atef Kamel Salama Kasr Al ainy St Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Salama atef.kamel@kasralainy.edu.eg +201224616643 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
Role Name Email Phone Street address
Public Enquiries Atef Salama atef.kamel@kasralainy.edu.eg +201224616643 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Ahmed El sakka ahmedsakka2@hotmail.com +201002414221 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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