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.: PACTR202307748580298 Date of Approval: 28/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Feasibility, Acceptability, and Outcomes of Sterile Water Injection (SWI) in Managing Lower Back Pain among Labouring Women in a Tertiary Hospital in Ghana: A Mixed-method Study.
Official scientific title Feasibility, Acceptability, and Outcomes of Sterile Water Injection (SWI) in Managing Lower Back Pain among Labouring Women in a Tertiary Hospital in Ghana: A Mixed-method Study.
Brief summary describing the background and objectives of the trial Sterile Water Injections (SWI) is an effective, evidence-based option for managing low back pain for labouring women. However, Ghanaian women in labour do not have SWI as an option for managing low back pain during birth despite the negative effects of unmanaged pain on both the labouring woman and her baby. This study aims to explore the clinical effectiveness, feasibility, acceptability, and outcomes of implementing sterile water injection (SWI) in managing lower back pain among labouring women in Ghana. The study will use a mixed-method approach (Convergent-parallel) consisting of a non-randomised clinical trial and qualitative interviews to prospectively select pregnant women and administer sterile water injections to those with low back pain. Midwives will be trained to administer the sterile water injections to those who consent. Data collection will be in three phases after recruiting and training of the midwives. Both quantitative and qualitative data will be collected from the women, midwives and other stakeholders. Data collection tools will include VAS tool for pre, intra and post implementation tools, satisfaction surveys for the women and interviews for the different participant groups (women, midwives and stakeholders). Data will be analysed both quantitatively and qualitatively. The quantitative aspect will be analysed with SPSS version 24.0 whereas the qualitative data will be managed using Nvivo software version 12. Descriptive and inferential analysis will be done for the quantitative aspect of the study, whereas thematic analysis will be used to identify the main and sub-themes emerging from the qualitative arm of the study.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SWIS
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/12/2022
Actual trial start date 12/06/2023
Anticipated date of last follow up 28/03/2023
Actual Last follow-up date 13/10/2023
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 46
Recruitment status Not yet recruiting
Publication URL https://www.cdu.edu.au/research-and-innovation/research-ethics-and-integrity/human-research-ethics
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 Non-randomised 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
Experimental Group Sterile Water Injection 0.1ml to 0.3ml of sterile water injections Less than 1minute of injection with a pain relief of up to 2hours or more. Sterile water injections of between 0.1 -0.3ml will be administered to women in labour with significant low back pain. The sterile water injections are administered using a 25-gauge needle (insulin or tuberculin syringe) into the skin of the birthing woman. Four injections will be administered by two midwives simultaneously during the first stage of labour at the woman’s lumbar-sacral area, boarded by the Rhombus of Michaelis (lower back usually identified by dimpling at the area). The injections cause a brief but painful stinging or burning sensation, that lasts for about 30 seconds and then goes away completely. To distract from the sting the injections are done during a contraction. Study information will be made available at the antenatal clinic (ANC) to prepare women. Immediately following enrolment in the labour ward, the first injection will be administered then any time you request for repeat injections, it will be given. The back pain is assessed with a validated instrument (VAS ≥ 7) at specific intervals (pre injection, 10, 30, 60, 90 and 120 minutes) in the first and second stage of labour. 27
Control Group Standard Treatment No sterile water injections will be administered but routine care as prescribed by facility Low back pain will be assessed at 10,30,60,90 and 120minutes respectively but no sterile water injections will be administered. Standard pain relieving options will be given based on the hospital's protocol. 27 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age 18 years and above - Women at term (between 37 completed weeks and 41 completed weeks) - Primip - Singleton pregnancy - Cephalic presentation - First-stage labour (spontaneous or induced) - Back pain assessed by VAS as ≥7 - Women whose labour would be considered high risk such as elderly primip (≥40years), women with high blood pressure (pre-eclampsia), insulin-dependent diabetic pregnant women, infections at the injection site, and those women with clotting problems. - Those women whose consent is required to be provided by a spouse for cultural reasons. - Women of non-English speaking backgrounds, Twi, Ga, Hausa, or Ewe (These are the common Ghanaian languages) where an interpreter is not available. Adult: 19 Year-44 Year 18 Year(s) 39 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 01/09/2022 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
7 Ellengowan Drive, Brinkin Darwin 0810 Australia
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 08/06/2023 Korle Bu Teaching Hospital IRB
Ethics Committee Address
Street address City Postal code Country
22nd Guggisberg Road Accra 000 Ghana
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 10/07/2023 FDA Clinical Trials
Ethics Committee Address
Street address City Postal code Country
17 Indian Ocean Street, Nelson Mandela Ave Accra 000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of women with low back pain who will consider sterile water injection for its clinical effectiveness Before injection to after labour
Secondary Outcome - VAS Measurement before intervention and after injection at 30, 60, 90 minutes. 30minutes to 90 minutes after intervention
Secondary Outcome - Proportion of women who report >30% reduction in VAS scores at 30 minutes after SWI administration 30minutes after sterile water injection
Secondary Outcome - Proportion of women who report >50% reduction in VAS scores at 30 minutes after SWI administration 30minutes
Secondary Outcome Women’s satisfaction 3hours after birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Maternity Unit 22nd Guggisberg Avenue Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Charles Darwin University 7 Ellengowan Drive, Brinkin Darwin 0810 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Charles Darwin University 7 Ellengowan Drive, Brinkin Darwin 0810 Australia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sue Kruske sue.kruske@cdu.edu.au +61418882337 5 Burrell Court Larapinta
City Postal code Country Position/Affiliation
Alice Springs 0875 Australia Professor of Primary Health Care and NT Health
Role Name Email Phone Street address
Public Enquiries Jonas Afari jawuku100@yahoo.com +233546777700 12 Guggisberg Avenue, Korle-Bu Teaching Hospital
City Postal code Country Position/Affiliation
Accra Ghana Specialist Anaesthesiologist
Role Name Email Phone Street address
Scientific Enquiries Nigel Lee nigel.lee@uq.edu.au +61731636118 St Lucia, Level 3 Chamberlain, Building, School of Nursing Midwifery and Social Work,
City Postal code Country Position/Affiliation
Brisbane Queensland Australia Lecturer and Researcher
Role Name Email Phone Street address
Principal Investigator Awube Menlah awube.menlah@cdu.edu.au +233203364436 Valley View University Street, Oyibi
City Postal code Country Position/Affiliation
Accra Ghana PhD Candidate
Role Name Email Phone Street address
Public Enquiries Clare Davison clare.davison@cdu.edu.au +61403968409 7 Ellengowan Drive, Brinkin
City Postal code Country Position/Affiliation
Darwin 0810 Australia Lecturer and Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The analysed de-identified individual patient will be made available long-term for use by future researchers. Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning ‘12 months following analysis and article publication with no end date Data will be made available to recognized research institutions whose proposed use of the data has been ethically reviewed and approved by an independent committee and establishment of a data sharing agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.cdu.edu.au/research-and-innovation/research-ethics-and-integrity/human-research-ethics 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