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.: PACTR202508881262388 Date of Registration: 12/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Comprehensive Couple Antenatal Health Education on Postpartum Depression among Women in Arsi Zone: A Randomized Controlled Trial using Modified Poisson Regression Model
Official scientific title Effect of Comprehensive Couple Antenatal Health Education on Postpartum Depression among Women in Arsi Zone: A Randomized Controlled Trial using Modified Poisson Regression Model
Brief summary describing the background and objectives of the trial Health Epidemiological studies, including individual surveys, systematic reviews, and meta-analyses, indicate that more than one in five women in Ethiopia experience postpartum depression. Evidence suggests that educating couples about maternal health services can stimulate health-seeking behaviors, improve adherence to the continuum of maternity care, and yield favorable health outcomes for women, newborns, and children. Despite the evident benefits, couple engagement in in reproductive health remains significantly underexplored, particularly in low-income countries. Current interventions rarely focus on couples during antenatal care, and there exists a paucity of randomized trials that evaluate the impact of couple involvement in reproductive health initiatives. Thus, this study aims to evaluate the effect of engaging couples in antenatal health education on postpartum depression among women in the Arsi zone, employing a randomized controlled trial design. The findings of this research are anticipated to inform policymakers and healthcare practitioners in the development of effective strategies for the prevention and management of postpartum depression, thereby contributing to reductions in maternal mortality and the overall enhancement of public health.
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 Education /Training
Anticipated trial start date 03/07/2023
Actual trial start date 03/07/2023
Anticipated date of last follow up 26/04/2024
Actual Last follow-up date 30/04/2024
Anticipated target sample size (number of participants) 621
Actual target sample size (number of participants) 585
Recruitment status Completed
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Comprehensive Couple Antenatal Health Education Three times 9 months The comprehensive couple antenatal health education content was pretested and covers several maternal health topics. Additionally, health education fliers, leaflets, posters, and videos containing the take-home messages in culturally adapted, easy-to-follow graphic materials were used to facilitate learning. The contents of the intervention were developed by referring to related published articles and WHO recommendations. The following are sample contents of those components.  Description of pregnancy: physical, physiological, and psychological changes.  Transition to fatherhood: Redefining values and priorities, acceptance, feeling, and behavioral changes.  Care of a pregnant woman, nutritional requirements and supplements, rest and emotional care, vaccination, pregnancy danger signs, sexually transmitted diseases, sexual activity during pregnancy and after delivery  Birth preparedness and complication readiness, signs and process of labor, support during delivery, and possible birth outcomes.  Baby care, breastfeeding, danger signs of a baby, and feeding the baby.  Family life: parenting and relationships within the family, paternal role & responsibility, couple relationship, domestic violence, substance use, and family planning. 195
Control Group Regular Antenatal care services. 3 9 Women in the control group received regular Antenatal care services. 390 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Married adult couples with no known mental health disorders attending antenatal care visits at Arsi Zone health facilities were eligible for the study. Those who are less than 18 years of age Women with a known mental health disorders Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Both
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 14/06/2023 Wolkite University Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
127 Wolkite 007 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postpartum depression 6-12 weeks postpartum
Secondary Outcome Infant development 12 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adama HO 123 Adama Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Girma Alemayehu 123 Wolkite 007 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Girma 123 Wolkite Ethiopia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Girma Beyene girmalemayehu16@gmail.com +251911056495 123
City Postal code Country Position/Affiliation
Wolkite Ethiopia Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Girma Beyene girmalemayehu16@gmail.com +251911056495 123
City Postal code Country Position/Affiliation
Wolkite Ethiopia Assistant Professor
Role Name Email Phone Street address
Public Enquiries Girma Beyene girmalemayehu16@gmail.com +251911056495 123
City Postal code Country Position/Affiliation
Wolkite Ethiopia Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification will be shared Statistical Analysis Plan Beginning 3 months and ending 5 years following article publication Researchers who provide 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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 07/08/2025 To ensure inclusion of individuals who are 18 years old, I selected the category 'Adolescent: 13–18 years.'" Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/08/2025 Comment from reviewer Experimental Group, Comprehensive Couple Antenatal Health Education , Three times, 9 months, The comprehensive couple antenatal health education content was pretested and covers several maternal health topics. Additionally, health education fliers, leaflets, posters, and videos containing the take-home messages in culturally adapted, easy-to-follow graphic materials were used to facilitate learning. The contents of the intervention were developed by referring to related published articles and WHO recommendations. The following are sample contents of those components.  Description of pregnancy: physical, physiological, and psychological changes.  Transition to fatherhood: Redefining values and priorities, acceptance, feeling, and behavioral changes.  Care of a pregnant woman, nutritional requirements and supplements, rest and emotional care, vaccination, pregnancy danger signs, sexually transmitted diseases, sexual activity during pregnancy and after delivery  Birth preparedness and complication readiness, signs and process of labor, support during delivery, and possible birth outcomes.  Baby care, breastfeeding, danger signs of a baby, and feeding the baby.  Family life: parenting and relationships within the family, paternal role & responsibility, couple relationship, domestic violence, substance use, and family planning. , 1, Experimental Group, Comprehensive Couple Antenatal Health Education , Three times, 9 months, The comprehensive couple antenatal health education content was pretested and covers several maternal health topics. Additionally, health education fliers, leaflets, posters, and videos containing the take-home messages in culturally adapted, easy-to-follow graphic materials were used to facilitate learning. The contents of the intervention were developed by referring to related published articles and WHO recommendations. The following are sample contents of those components.  Description of pregnancy: physical, physiological, and psychological changes.  Transition to fatherhood: Redefining values and priorities, acceptance, feeling, and behavioral changes.  Care of a pregnant woman, nutritional requirements and supplements, rest and emotional care, vaccination, pregnancy danger signs, sexually transmitted diseases, sexual activity during pregnancy and after delivery  Birth preparedness and complication readiness, signs and process of labor, support during delivery, and possible birth outcomes.  Baby care, breastfeeding, danger signs of a baby, and feeding the baby.  Family life: parenting and relationships within the family, paternal role & responsibility, couple relationship, domestic violence, substance use, and family planning. , 195,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 07/08/2025 Comment from reviewer Control Group, Regular Antenatal care services., 3, 9, Women in the control group received regular Antenatal care services., 1, Active-Treatment of Control Group Control Group, Regular Antenatal care services., 3, 9, Women in the control group received regular Antenatal care services., 390, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 07/08/2025 Based on comment from trial reviewer No fund received, 123, Wolkite, 007, Ethiopia, Self Funded, Girma Alemayehu, 123, Wolkite, 007, Ethiopia, Self Funded,