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.: PACTR202304525632216 Date of Approval: 19/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving the quality of life in women who experienced maternal near miss in Kilimanjaro, Tanzania
Official scientific title Effect of supportive psychotherapy on improving the quality of life in women who have experienced maternal near miss in Kilimanjaro, Tanzania
Brief summary describing the background and objectives of the trial Women are considered maternal near-miss cases when they survive severe life-threatening pregnancy-related conditions. Its prevalence globally is 18.7 per 1000 live births, which is higher in low-income countries than in high-income countries. In Sub-Saharan Africa, the magnitude is 24 per 1000 live births, and in Tanzania the prevalence varies from 24 - 87 per 1000 live births. Women who experienced maternal near-miss report low quality of life. Supportive psychotherapy treatments have improved the quality of life in women with miscarriages. Therefore, the primary objective of this study is to determine the effect of supportive psychotherapy to improve the quality of life in women who experienced maternal near-miss in Kilimanjaro, Tanzania.
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 02/05/2023
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
2581 KCMUCo-Research ethics committee
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 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 supportive psychotherapy three weeks with three therapy sessions, one per week. Supportive psychotherapy A trained research assistant in supportive psychotherapy will conduct three sessions that will take 30 minutes to 1 hour based on the patient's needs every week per session. The first week will include the creation of rapport between therapist and clients, listening, normalising and validating client's experiences. In addition, the introduction of psycho-education on physical and mental well-being. The therapist will empathetically listen to the client's emotional catharsis. Moreover, they use unconditional positive regard. Interaction with a therapist will provide emotional support for psychological burnout. Introduce coping mechanisms, such as breathing relaxation demonstration with visual descriptions. The second week: will include an assessment of reduced symptoms and those still existing and assessing the progress of skills implementation. Introduce new coping skills if needed. The third week: Will include prevention techniques for problem relapse and termination of supportive psychotherapy treatment. 70
Control Group standard health care three weeks Standard healthcare A trained research assistant will provide the three sessions of standard health care to women who have experienced Maternal Near Misses. Each session will take 30 minutes to 1 hour every week. First week: This will include the creation of rapport, physiological assessment, vital signs, perineal healing, wound healing, presence of back pain, and body hygiene, teaching on proper attachment and good positioning of babies for best breastfeeding, eating a balanced diet, and having enough time for resting, Second week: Counselling on postpartum contraceptive used, Third week: HIV counselling, testing and prevention, which will take three weeks. At the termination of standard health care, a post-test will be performed three months later to assess for changes. 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Women 15-49 years of age • Women who experienced maternal near miss • Women who are residing in the Kilimanjaro region, Tanzania • Women who are in psychiatric treatment or attending any counselling session. • Women with severe depression or anxiety • Women who are unable to consent • Women who refuse to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 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 02/03/2023 National Institute of Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive, box 9653, 11101 Dar es salaam Dar es salaam 00000 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome quality of life Immediate after intervention and three months later
Secondary Outcome mental health status Immediate after intervention and three months later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Centre Hospital 3010, Moshi Kilimanjaro 00000 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Higher Education Student Loan Board HESLB house, 1 Kilimo street, Tazara Road, Box 76068, 15471 Dar es salaam 00000 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kilimanjaro christian Medical University College Kilimanjaro Medical Centre Moshi United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Enna Sengoka enna.sengoka@yahoo.com +255762250564 KCMC
City Postal code Country Position/Affiliation
Moshi Tanzania PhD Student Head Nurse Department of Gynaecology
Role Name Email Phone Street address
Public Enquiries Gilegard Masenga drgmasenga@gmail.com +255272754377 KCMC
City Postal code Country Position/Affiliation
Moshi Tanzania Managing Director KCMC
Role Name Email Phone Street address
Scientific Enquiries Gunilla Bjorling gunilla.bjorling@ju.se +46722505020 Barnarpsgatan 39
City Postal code Country Position/Affiliation
Jonkoping 55111 Sweden Professor
Role Name Email Phone Street address
Scientific Enquiries Michael Johnsson Mahande jmmahande@gmail.com +255759929962 KCMC
City Postal code Country Position/Affiliation
Moshi Tanzania Professor KCMUCo
Role Name Email Phone Street address
Scientific Enquiries Janet Mattsson janet.mattsson@hkr.se +467033759 Kristianstad University
City Postal code Country Position/Affiliation
Kristianstad Sweden Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in articles, after deidentification (text, tables, figures, and appendices) will be shared upon request. Informed Consent Form Beginning 9 months and ending 36 months following article publication. Researchers who provide a methodologically sound proposal.
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