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.: PACTR202404823279671 Date of Approval: 25/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postpartum Depression Among Mothers With Birth Complications: A Randomized Control Trial Of Mobile Health, Facility And Home-Based Strategies In Tertiary Hospital In Ghana.
Official scientific title Postpartum Depression Among Mothers With Birth Complications: A Randomized Control Trial Of Mobile Health, Facility And Home-Based Strategies In Tertiary Hospital In Ghana.
Brief summary describing the background and objectives of the trial Background Postpartum depression is a mood disorder that poses challenges in the postpartum period for the mother, infant and the entire family. Postpartum depression continues to impact mothers, their infants and their families negatively and can present in a severest form leading to suicide and infanticide. Among mothers with birth complications, postpartum depression might be more prevalent due to extreme physical, emotional and physiological changes during birth and beyond. In Ghana, postpartum depression prevalence ranges between 7% and 41% (Sefogah et al., 2020; Anokye et al., 2018) and might even be higher in the population of mothers with birth complications. Despite the high prevalence of postpartum depression, the interventions and strategies for treating and improving the disorder are limited in the Ghanaian context. Given the gap in treatment, the study seeks to determine the effectiveness of cognitive behavioural therapy through mobile health, facility and home-based strategies for improving postpartum depression among mothers with birth complications. Objectives of the Study Main Objective The study seeks to determine effective strategies to improve postpartum depression among mothers with birth complications. Specific objectives 1. To examine the prevalence of postpartum depression among mothers with birth complications. 2. To determine the effectiveness of mobile health strategy on postpartum depression. 3. To evaluate home-based strategy for improving postpartum depression 4. To assess the effects of facility-based strategy on postpartum depression 5. To identify associations between sociodemographic and postpartum depression.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 25/09/2023
Actual trial start date 30/09/2023
Anticipated date of last follow up 10/09/2024
Actual Last follow-up date 10/09/2024
Anticipated target sample size (number of participants) 168
Actual target sample size (number of participants) 168
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 Permuted block randomization 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
Experimental Group cognitive behavioural therapy and the standard routine postnatal care weekly four weeks The intervention group will receive education in cognitive behavioural therapy support weekly for four weeks during the study together with the standard routine postnatal care. The three arms: mobile health, home-based, and facility-based strategies will receive the standard routine postnatal care and cognitive behavioural therapy The cognitive behavioural therapy for mothers with postpartum depression and birth complications will be based on three areas of support; 1. Adaptation: Exploring mothers' thoughts, feelings, and behaviour and helping them adapt to new roles as mothers in the postpartum period. 2. Reflection: Helping mothers reflect on activities and the reality of the situation they find themselves in and providing them with information on motivational, affective, social and physiological systems to enhance the quality of life. 3. Stimulus- response network: Helping mothers plan daily living activities and goals and expectations within their means. 84
Control Group Standard routine postnatal care four times 6 weeks Standard routine postnatal care Immediate care: This includes regular monitoring of vital signs, such as blood pressure, temperature, and pulse. Assessment of the mother's recovery from childbirth. Subsequent postnatal care involves monitoring the newborn's health and development, including weight, feeding, and overall well-being. Guidance and support to mothers on breastfeeding techniques, proper positioning and attachment, and education on newborn care 84 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers who will give birth at Cape Coast Teaching Hospital during the study period. Encountered birth complications and aged 15 years and above. Mothers who plan to stay in Ghana for three months after childbirth, have an active phone number and are willing to participate in the study. Having depression Mothers with a previous history of mental disorders or cognitive impairment. Mothers whose health conditions might not permit them to participate in the study. 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 18/05/2023 Cape Coast Teaching Hopital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Abura Cape Coast CT 1363 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 13/09/2023 Kamuzu University of Health Sciences College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Blantyre Blantyre PB 360 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in depressive symptoms Measurements are done after receiving a week after the last session of the intervention
Secondary Outcome Positive changes in cognitive functioning During fouth session of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cape Coast Teaching Hospital Abura Cape Coast CT 1368 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Science University of Cape Coast Cape Coast PMB Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Naomi Kyeremaa Yeboa Science University of Cape Coast Cape Coast PMB Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naomi Kyeremaa Yeboa naomi.yeboa@ucc.edu.gh +233555027783 School of Nursing, Univesity of Cape Coast, Science
City Postal code Country Position/Affiliation
Cape Coast PMB Ghana Student
Role Name Email Phone Street address
Public Enquiries Ursula Kafulafula ukafulafula@kuhes.ac.mw +265888878290 Blantyre
City Postal code Country Position/Affiliation
Blantyre PB 360 Malawi Supervisor
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Chodzaza echodzaza@kuhes.ac.mw +265888333891 Blantyre
City Postal code Country Position/Affiliation
Blantyre PB 360 Ghana Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Upon completing this randomized controlled trial and publishing primary outcomes, individual participant data (IPD) will be made available to qualified researchers, subject to ethical and legal considerations. Access to IPD will be granted through a controlled, secure system managed by a committee. Researchers interested in accessing the data must submit a request outlining their research objectives, methodology, and intended use of the data. Data will be de-identified to protect participant confidentiality. For inquiries regarding data sharing, please contact the principal investigator on email 202250010014@kuhes.ac.me or naomi.yeboa@ucc.edu.gh Statistical Analysis Plan,Study Protocol After 5years Research purpose, methodology, ethical considerations, and data security.
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