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.: PACTR202308866726753 Date of Approval: 21/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effectiveness of perineal cold application on reduction of postpartum maternal pain and timely initiation of breastfeeding among women after spontaneous vaginal delivery in Dodoma region
Official scientific title The effectiveness of perineal cold application on reduction of postpartum maternal pain and timely initiation of breastfeeding among women after spontaneous vaginal delivery in Dodoma region
Brief summary describing the background and objectives of the trial Worldwide over 60% of women have a spontaneous vagina birth (SVB), equating to an estimated 78.84 million births per annum. Who is commonly experienced perineal pain and dyspareunia, which limit the woman’s mobility, quality of life and ability to care for her baby comfortably (Manresa, 2019). The incidence and prevalence of perineal trauma documented worldwide are associated with tears, episiotomies, and vaginal lacerations. (Afshar, 2019) In sub-Saharan Africa, it is estimated that 70 to 85% of women sustain some degree of trauma to the perineum during childbirth (Mantzius et al., 2020). Perineal pain and dyspareunia are commonly experienced in the short and longer term by women undergoing vaginal birth(Manresa, 2019). Perineal pain can impair and hurting a mother’s adaptation to her new role (Mantzius et al., 2020). Likewise, dyspareunia is usually reported in the long-term postnatal period, which can affect sexual health and relationships (Fahami et al.,2012). Perineal trauma can have long-term social, psychological and physical health consequences, and for women and discomfort may disrupt breastfeeding, family life and sexual relationship(Steen, 2010) However, researchers have gained much insight into the importance of using ice packs for localizing treatment in relieving perineal pain after a child’s standard delivery (Leventhal et al., 2011); (Edqvist et al., 2020); Jahdi et al., 2010); little is known/done about perineal cold application therapy in Tanzania. However, prior research confirmed that the localizing treatment using an ice pack to relieve perineal pain was safe; women had maximum satisfaction than other methods (Leventhal et al., 2011). the objective of this study is to determine the effectiveness of perineal cold application on reduction of postpartum maternal pain and timely initiation of breastfeeding among mothers with spontaneous vagina delivery in Dodoma Region
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 23/08/2023
Actual trial start date 01/09/2023
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date 31/10/2023
Anticipated target sample size (number of participants) 228
Actual target sample size (number of participants) 228
Recruitment status Not yet 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 by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group pharmacological treatment 500mg 1hour the control group will be given paracetamol ana tested for the intensity of pain before and after every 20minutes for the duration of one hour 114 Placebo
Experimental Group Perineal cold application One cold pack for one hours application sepof cold pack to the perineum after child birth and followed for pain relief measures at 20 minutes interval 114
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
singleton birth Birth weight (2500g and above) full-term 18 to 49 years of age who had perineal pain postpartum hemorrhage eclampsia shock medical disorders fetal anomaly neonates admitted in the intensive care unit retained placenta consumption of alcohol or continuous drugs rupture membranes >12 hours, 3rd or 4th degree perineal tear perineal hematoma perineal oedema Adult: 19 Year-44 Year 18 Year(s) 49 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 17/08/2023 The Vice of the University of Dodoma Ethical Board
Ethics Committee Address
Street address City Postal code Country
Benjamin Mkapa ,p.o. box 259,41107Dodoma Dodoma 41107 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain relief after every 20 minutes
Secondary Outcome Initiation of breast feeding within one hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dodoma Regional Referal Hospital P.O.Box 1249, Dodoma Dodoma Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Dodoma City Council P.O.Box 1249 Dodoma Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pastory Bundala Miyuji Proper Dodoma United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joyce Augustino kimariojoyce652@gmail.com 255745386372 Miyuji Proper
City Postal code Country Position/Affiliation
Dodoma Tanzania Nursing officer
Role Name Email Phone Street address
Scientific Enquiries Fabiola Moshi fabiola.moshi@gmail.com 255767837019 Ilazo
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Lecturer University of Dodoma
Role Name Email Phone Street address
Public Enquiries Angelina Joho Johoangeljoho@yahoo.co.uk 255714638166 Benjamin
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data that underlie the results that will be reported from this study, after the deidentification of identifiers in text and tables, will be shared. I will first share with the Council Health management team (CHMT) and Regional Health management team (RHMT) in the Dodoma region. I will further share the report with higher authorities, such as the President’s Office, the Regional Administrative Secretary and Local Government (PORALGT), and the Ministry of Health. Lastly will be publicly available at Figshare repository Study Protocol 1/10/2023- 1/07/2023 all data will be publicly available on the Figshare website
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