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.: PACTR201905534072247 Date of Approval: 13/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Spinal labour analgesia
Official scientific title Prospective study of spinal heavy bupivacaine versus plain bupivacaine for late labour analgesia
Brief summary describing the background and objectives of the trial Study of the difference between heavy and plain bupivacain for late labour analgesia , which drug will give rapid response with favourable action on mother and fetus .
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 Treatment: Drugs
Anticipated trial start date 04/03/2019
Actual trial start date 01/03/2019
Anticipated date of last follow up 20/03/2019
Actual Last follow-up date 20/08/2019
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status 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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Heavy bupivacaine with fentanyl 2.5 mg heavy bupivacaine with 15 mic fentanyl Once 0.5 ml of heavy bupivacaine with 15 mic fentanyl completed to 3 ml total volume with saline 100 Uncontrolled
Experimental Group Plain bupivacaine combined with fentanyl 2.5 mg plain bupivacaine with 15 mic fentanyl Once 2.5 mg plain bupivacaine ...0.5ml plain bupivacaine with 15 mic fentanyl complete volume to 3 ml with normal saline 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASAI,II patient primgradiva or multigravida, in labour with cervical dilation 6 to 7 cm or more, No major cardiovascular ,respiratory or systemic disease. Age 18 to 35 years. Major cardiovascular ,respiratory or systemic disease, Coagulopathy, Patient refusal, Infection at site of injection. 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 01/03/2019 Elmenfia university ethical committe
Ethics Committee Address
Street address City Postal code Country
25- yassin Abdel ghafar Shibin alkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Better analgesia, rapid onset with which group during insertion of epidural catheter which done after spinal injection First 5 minutes
Secondary Outcome Maternal hemodynamics , any fetal effects , patient satisfaction , duration of analgesia . Maternal hemodynamics will be measured at baseline , 5 ,15 , 30 ,60 minutes after spinal, fetus apgar score at 1,5 ,10 minutes after delivery, duration of analgesia with first request to activate epi
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El mencia university 25- yassin abd ellghafar street Shibin elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hanaa about elfetouh 2525-yassin abdelghafar Shibin elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Elmenoufia university 25 -yassin abdelghafar Shibin elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nadia mohie 25-yassin abdelghafar street Shibin elkom 002048 Egypt
Hazem elsersy 2525-yassin and elghafar Shibin elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanaa Elfeky hanaafotoh@yahoo.com 00971508987298 25-yassin abdelghafar street
City Postal code Country Position/Affiliation
Shibin elkom 002048 Egypt Lecturer of anesthesia and ICU elmenoufia university
Role Name Email Phone Street address
Scientific Enquiries Nadia Mohie dr_nmbahgat@yahoo.com 0020222850598 25-yassin abdelghafar street
City Postal code Country Position/Affiliation
Shibin elkom 002048 Egypt Lecturer of anesthesia and ICU elmenfia university
Role Name Email Phone Street address
Public Enquiries Hazem Elsersy hazelsersy@hotmail.com 00201091096655 25-yassin abdelghafar street
City Postal code Country Position/Affiliation
Shibin elkom 002048 Egypt Assistant professor of anesthesia and ICU elmenoufia university.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will measure, demographic data, vitals pulse blood pressure respiratory rate and fetal heart rate, onset, sensory level ,motor block ,duration ,or satisfaction, pain score,time of first and second stage , instrumental delivery, fetal ABG and abgar score. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months, about first of April 2020 Patient in labour, heavy marcain and plain marcain
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