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.: PACTR201908713181850 Date of Approval: 12/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of leg elevation on prevention of post spinal hypotension for those patients who undergo elective caesarean section under spinal anesthesia.
Official scientific title Effectiveness of leg elevation on prevention of post spinal hypotension for those patients who undergo elective caesarean section under spinal anesthesia.
Brief summary describing the background and objectives of the trial Post spinal hypotension is the most common complication of spinal anesthesia for cesarean section (CS). Post spinal hypotension (PSH) is mainly occur due to the reductions of vascular tone leading to decreased systemic vascular resistance and decreased venous return. Leg elevation leads to increased stroke volume and consequently cardiac output. The objective of this study is to assess the efficacy of leg elevation (LE) as a method of prevention of post-spinal hypotension in patients who undergo cesarean section under spinal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 25/02/2019
Actual trial start date 10/03/2019
Anticipated date of last follow up 01/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Leg elevation Leg elevation performed for 30 cm using two standard pillows 15 minutes Leg elevation 30 cm performed using two standard pillows positioned under heels so that the leg elevated approximately 40 degree above horizontal plane. 26
Control Group Control group 15 minutes Control group were positioned in regular supine position 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Elective cesrean section Age 18-35 • Patient refusal • Failed spinal block or total spinal converted to general anesthesia • Those patient who have Sepsis (SIRS with a focus of infection) • Those patient who have Infection at the puncture site • Those patient who have severe cardiac disease graded Class (NYHA) III –I • Hypertensive disorders of pregnancy. • Obesity (BMI ≥29 kg/m2) • Patients with baseline hypotension (systolic blood pressure (SBP) < 100 mmhg) or antepartum bleeding will also exclude from the study. • Height <155 cm • Patient who have history of local anesthetic drug allergy. • Multiple pregnancy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 35 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 04/09/2018 Dilla university institutional review board
Ethics Committee Address
Street address City Postal code Country
Dilla university Dilla 5050 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of hypotension 3 minutes
Secondary Outcome Severity of hypotension, incidence of nausea and vomiting and vasopressors consumption 3 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla university Referral hospital Dilla Dilla Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla university Dilla university Dilla 5050 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla university Dilla university Dilla 5050 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Hailemariam Mulugeta head department of anesthesiology and critical care DIlla Dilla Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Bedru Jemal bedruanst@gmail.com +251924415702 Dilla
City Postal code Country Position/Affiliation
Dilla 5050 Ethiopia Dilla University Referral hospital
Role Name Email Phone Street address
Principal Investigator Sofia Assen Sofiaassen6@gmail.com +251921790076 Dilla
City Postal code Country Position/Affiliation
Dilla 4040 Ethiopia Dilla university referral hospital
Role Name Email Phone Street address
Public Enquiries Adane Tesfaye Adanesfaye2006@gmail.com +25116857437 Dilla
City Postal code Country Position/Affiliation
Dilla 2020 Ethiopia Dilla university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data is available in software Informed Consent Form,Study Protocol Monthly Email
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes LE group showed lower incidence of post spinal hypotension (PSH) (25%) compared to control group (44.4%) with P = 0.29 and relative risk of 0.68(95%CI 0.44-1.22). The proportion of severe hypotension was lower in leg elevation group (0%) compared to controlled group (5.6%) with p value of 0.45. Intra-operation nausea and vomiting was lower in the leg elevation group compared to control group. 10/08/2019 13/10/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://go.microsoft.com/fwlink/p/?LinkId=255141
Changes to trial information