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.: PACTR201702001933278 Date of Approval: 24/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Epidural labour analgesia services: Effect, challenges and outcome of clinical intervention
Official scientific title Epidural labour analgesia services: Effect, challenges and outcome of clinical intervention-An open label randomised control trial
Brief summary describing the background and objectives of the trial Epidural analgesia is the gold standard for pain relief in labour because of improve maternal cardio-respiratory physiology. In our institution, mothers do request for epidural labour analgesia, but has been rarely used to the best of our knowledge because of anticipated challenges from patient¿s and staff to institutional factors that may affect setting up epidural services protocol. Possible challenges shall be scrutinized in the recruited groups from booking till after delivery. We often use pentazocine injection for unbearable labour pain cases with unsatisfactory outcome We, therefore aim to hypothesize that an appropriate clinical intervention on the likely challenges of epidural services in labour and its protocol in a group may bring positive effects and better outcome than in the control group without intervention. Objectives: 1. To assess patient¿s awareness about epidural relief in labour in the two groups 2. To identify parturient who would request for epidural labour analgesia and follow them up till delivery and immediate post partum 3. To identify factors that determine choice of epidural labour analgesia 4. To evaluate and compare challenges of labour analgesia in the two groups
Type of trial RCT
Acronym (If the trial has an acronym then please provide) nil
Disease(s) or condition(s) being studied labour pain,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/01/2017
Actual trial start date 03/01/2017
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date 30/06/2017
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Not yet recruiting
Publication URL Nil
Secondary Ids Issuing authority/Trial register
not applicable not applicable
not applicable not applicable
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised By coin-tossing into either interventional group (Group A or non-interventional group (Group B) The person allocating the participants would close his or her eyes while tossing the coin. Two different persons will represent head or tail of the coin for the interventional and non-interventional group respectively Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A Not applicable Not applicable Awareness on epidural labour analgesia will be created to pregnant women at booking clinic through video show inform of youtube on epidural labour analgesia in addition to distribution of epidural card (oaa format). A proforma each will be given to articipant to be filled which include willingness to or not to request for epidural when in labour. 60
Control Group GROUP B Not application 6 months No awareness programme on epidural labour analgesia for this Group B at the antenatal booking clinic. That is, no video show or epidural labour analgesia and no distribution of epidural information leaflet(card) until after booking and submission of the proforma on awareness. 60 Historical
Control Group GROUP B Not application 6 months No awareness programme on epidural labour analgesia for this Group B at the antenatal booking clinic. That is, no video show or epidural labour analgesia and no distribution of epidural information leaflet(card) until after booking and submission of the proforma on awareness. 60 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Normal pregnancy Booking for the first time High risk pregnancy like twin pregnancy, abnormal positioning, abnormal clotting profile, eclampsia. Patient's refusal 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 28/06/2016 Ethics and Research Committee OAUTHC
Ethics Committee Address
Street address City Postal code Country
Ilesa road Ile-Ife 220005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome identification of challenges facing non administration of epidural labour analgesia to parturients At presentation when in established labour At delivery After delivery
Secondary Outcome Effect of the level of awareness on epidural labour pain relief At booking At presentation when in established labour At delivery Post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Ilesa road Ile-Ife 220005 Nigeria
Obafemi Awolowo University Teaching Hospitals Complex Wesley Guild Ilesa 220005 Nigeria
Obafemi Awolowo University Wesley Guild Ilesa 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal MDCAN Building Ile-Ife 220005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Simeon Olateju Department of Anaesthesia, Obafemi Awolowo University Ile-Ife 220005 Nigeria University
Secondary Sponsor Simeon Olateju Department of Anaesthesia, Obafemi Awolowo University Ile-Ife 220005 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Tade Ijarotimi Ilesa road Ile-Ife 220005 Nigeria
Adedapo Adetoye Ilesa road Ile-Ife 220005 Nigeria
Adedapo Adetoye Ilesa road Ile-Ife 220005 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Simeon Olateju gbadeteju2005@yahoo.com +2348033885482 Department of Anaesthesia, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile-Ife 234 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Simeon Olateju gbadeteju2005@yahoo.com +2348033885482 Department of Anaesthesia, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile-Ife 234 Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Simeon Olateju gbadeteju2005@yahoo.com +2348033885482 Department of Anaesthesia, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile-Ife 234 Nigeria Senior Lecturer
REPORTING
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