Trial no.:	PACTR202512868895726	Date of Registration:	04/12/2025
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Effectiveness of Couple Based Maternity Education on Husband Involvement in Maternity Continuum of Care Among Rural Communities of Ethiopia; Cluster Randomized Control Trial

Official scientific title

Couple Based Maternity Education on Husband Involvement in Maternity Continuum of Care Service Utilization in Ethiopia; Cluster Randomized Control Trial

Brief summary describing the background and objectives of the trial

Brief Summary Husband engagement on maternity continuum of care can encourage and assist in changing the husband’s behavior, enhance health care-seeking, at-home care practices and lead to greater levels of love, happiness, and emotional closeness in partnerships. Especially in developing countries husbands have high impact on the mothers' and newborns' health as leaders in their communities, religions, politics and as they have the power to alter societal norms and behaviors. Couple based maternity education can enhance the husband's own sexual and reproductive health, and strengthen the husband's advocacy roles for the health of mothers and children and improve ANC visits, better preparation for birth, giving birth in a health facility and postnatal care. Different study findings reveal that in underdeveloped nations pregnancy and delivery are viewed as women's domains and husbands are typically not expected to accompany their wives to the prenatal clinic, be there during child birth, or assist with postnatal care. The husband's involvement is one factor that can affect the first two delays (the timely recognition of complications and the identification and arrival at a health facility) in the "model of three maternal delays" that result in maternal deaths are directly related to issues with access to care and husband involvement. International communities like International Conference on Population and Development and World health organization have put forward the involvement of husbands in mCoC as an essential intervention strategy to improve maternal and neonatal health outcomes and formally recognized the dynamic role of husbands in promoting mother and child health. Aim of the study To assess the Effectiveness of couple-based maternity education on husbands’ involvement in maternity continuum of care in rural Ethiopia

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

mCoC

Disease(s) or condition(s) being studied

Pregnancy and Childbirth

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Education /Training

Anticipated trial start date

10/11/2025

Actual trial start date

20/11/2025

Anticipated date of last follow up

10/06/2026

Actual Last follow-up date

10/07/2026

Anticipated target sample size (number of participants)

496

Actual target sample size (number of participants)

496

Recruitment status

Recruiting

Publication URL

0283/25

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 a randomization table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Behavioral change intervention	The intervention arm will receive Couple-based maternity education intervention for six months starting from the beginning of the second trimester pregnancy period. The intervention package is comprised of two components with in five contacts: group maternity education will be the first and third contact whereas home visit will be the second, forth and fifth contact.	Six months	The trained health professionals will provide couple-based maternity education for husbands and pregnant women in intervention group for the six month period. During intervention trained health professionals will focuses on the importance of husband’s participation in ANC and the services they provide during ANC visits, pregnancy risk indicators and difficulties, the benefits of institutional birth, and the advantages of PNC visit. It will center on the importance of open communication between partners throughout the pregnancy, the role of the husband in accompanying his partner to the health institution for prenatal care, delivery, and PNC, the need for emotional support during pregnancy, and providing financial support, including transportation to the health institution during pregnancy. There is also individual home visits and couples will receive counselling and husbands will be advised to assist the wife.	248
Control Group	No Intervention	Routine care	Routine care	The routine care will be continued in the control group	248	Placebo

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
A couple whose wife with in the beginning of second trimester of pregnancy Couples those living together Couples who had a history of delivery in the last 3 years Couple lived in the study area for at least six months Volunteered to take part in couple-based maternal education	Couples who are seriously ill Couples who intend to leave the intervention and control groups within the next six months	Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	64 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

02/10/2025

Wolaita Sodo University Institutional Review Board

Ethics Committee Address
Street address	City	Postal code	Country
Woalita Sodo Unversity	Sodo	138	Ethiopia

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Husband involvement in skilled delivery service utilization	Pre-and post-intervention
Primary Outcome	Skilled delivery service utilization	Pre-and post-intervention
Secondary Outcome	Husbands’ knowledge on obstetric danger sign	Pre-and post-intervention
Secondary Outcome	Husbands’ attitude towards their involvement on maternity continuum of care	Pre-and post-intervention

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Hadiya Zone Central Ethiopia Region	Hadiya	Hossana	667	Ethiopia
Wachemo University	Hadiya	Hossana	667	Ethiopia

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Wolaita Sodo University	Sodo, Southern Ethiopia Region	Sodo	138	Ethiopia

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Wolaita Sodo University	Wolaita Sodo, Southern Ethiopia Region	Sodo	138	Ethiopia	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Lonsako Abute Woiloro	bt.lnsk@gmail.com	+251912274086	Wachemo University, Central Ethiopia
City	Postal code	Country	Position/Affiliation
Hossana	667	Ethiopia	Assistant Professor
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mengistu Meskele Koyra	mengistu77@gmail.com	+251913177996	Wolaita Sodo, Southern Ethiopia
City	Postal code	Country	Position/Affiliation
Sodo	138	Ethiopia	Associate Professor
Role	Name	Email	Phone	Street address
Scientific Enquiries	Takele Tadesse Adafrie	takeletadesse1627@gmail.com	+251911287641	Wolaita Sodo, Southern Ethiopia
City	Postal code	Country	Position/Affiliation
Sodo	138	Ethiopia	Professor
Role	Name	Email	Phone	Street address
Public Enquiries	Amene Abebe Kerbo	ameneabe@gmail.com	+291911050812	Wolaita Sodo, Southern Ethiopia
City	Postal code	Country	Position/Affiliation
Sodo	138	Ethiopia	Associate Professor

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	I have a plan to share Baseline characteristics, outcome measure and statistical analysis	Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol	Starting from November 20 until to 8 months.	Couple, maternity education, husband involvement, Ethiopia
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
0283/25	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
Trial Information	Trial description	18/11/2025	Review comment	Brief Summary Husband engagement on maternity continuum of care can encourage and assist in changing the husband’s behavior, enhance health care-seeking, at-home care practices and lead to greater levels of love, happiness, and emotional closeness in partnerships. Especially in developing countries husbands have high impact on the mothers' and newborns' health as leaders in their communities, religions, politics and as they have the power to alter societal norms and behaviors. Couple based maternity education can enhance the husband's own sexual and reproductive health, and strengthen the husband's advocacy roles for the health of mothers and children and improve ANC visits, better preparation for birth, giving birth in a health facility and postnatal care. Detailed Description Eventhuogh maternal and child health is determined by many factors including socio-economic status, healthcare facilities, the lack of women's autonomy and environmental factors, one important factor that has been neglected over the years is the husband’s role. Different study findings reveal that in underdeveloped nations pregnancy and delivery are viewed as women's domains and husbands are typically not expected to accompany their wives to the prenatal clinic, be there during child birth, or assist with postnatal care. The husband's involvement is one factor that can affect the first two delays (the timely recognition of complications and the identification and arrival at a health facility) in the "model of three maternal delays" that result in maternal deaths are directly related to issues with access to care and husband involvement. International communities like International Conference on Population and Development and World health organization have put forward the involvement of husbands in mCoC as an essential intervention strategy to improve maternal and neonatal health outcomes and formally recognized the dynamic role of husbands in promoting mother and child health. Ethiopia's Mini	Brief Summary Husband engagement on maternity continuum of care can encourage and assist in changing the husband’s behavior, enhance health care-seeking, at-home care practices and lead to greater levels of love, happiness, and emotional closeness in partnerships. Especially in developing countries husbands have high impact on the mothers' and newborns' health as leaders in their communities, religions, politics and as they have the power to alter societal norms and behaviors. Couple based maternity education can enhance the husband's own sexual and reproductive health, and strengthen the husband's advocacy roles for the health of mothers and children and improve ANC visits, better preparation for birth, giving birth in a health facility and postnatal care. Different study findings reveal that in underdeveloped nations pregnancy and delivery are viewed as women's domains and husbands are typically not expected to accompany their wives to the prenatal clinic, be there during child birth, or assist with postnatal care. The husband's involvement is one factor that can affect the first two delays (the timely recognition of complications and the identification and arrival at a health facility) in the "model of three maternal delays" that result in maternal deaths are directly related to issues with access to care and husband involvement. International communities like International Conference on Population and Development and World health organization have put forward the involvement of husbands in mCoC as an essential intervention strategy to improve maternal and neonatal health outcomes and formally recognized the dynamic role of husbands in promoting mother and child health. Aim of the study To assess the Effectiveness of couple-based maternity education on husbands’ involvement in maternity continuum of care in rural Ethiopia
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	11/11/2025	Review comment	Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)	Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	04/12/2025	PACTR Admin	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	11/11/2025	Review comment	Experimental Group, Randomized Control Trial , Couple-based maternity education The intervention arm will receive Couple-based maternity education intervention for six months starting from the beginning of the second trimester pregnancy period. The intervention package is comprised of two components with in five contacts: group maternity education will be the first and third contact whereas home visit will be the second, forth and fifth contact. , Six months , The trained health professionals will provide couple-based maternity education for husbands and pregnant women in intervention group for the six month period. During intervention trained health professionals will focuses on the importance of husband’s participation in ANC and the services they provide during ANC visits, pregnancy risk indicators and difficulties, the benefits of institutional birth, and the advantages of PNC visit. It will center on the importance of open communication between partners throughout the pregnancy, the role of the husband in accompanying his partner to the health institution for prenatal care, delivery, and PNC, the need for emotional support during pregnancy, and providing financial support, including transportation to the health institution during pregnancy. There is also individual home visits and couples will receive counselling and husbands will be advised to assist the wife., 248,	Experimental Group, Behavioral change intervention, The intervention arm will receive Couple-based maternity education intervention for six months starting from the beginning of the second trimester pregnancy period. The intervention package is comprised of two components with in five contacts: group maternity education will be the first and third contact whereas home visit will be the second, forth and fifth contact. , Six months , The trained health professionals will provide couple-based maternity education for husbands and pregnant women in intervention group for the six month period. During intervention trained health professionals will focuses on the importance of husband’s participation in ANC and the services they provide during ANC visits, pregnancy risk indicators and difficulties, the benefits of institutional birth, and the advantages of PNC visit. It will center on the importance of open communication between partners throughout the pregnancy, the role of the husband in accompanying his partner to the health institution for prenatal care, delivery, and PNC, the need for emotional support during pregnancy, and providing financial support, including transportation to the health institution during pregnancy. There is also individual home visits and couples will receive counselling and husbands will be advised to assist the wife., 248,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	11/11/2025	Review comment	Primary Outcome, Husband involvement in skilled delivery service utilization, 6 month	Primary Outcome, Husband involvement in skilled delivery service utilization, Pre-and post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	11/11/2025	Review comment	Primary Outcome, Skilled delivery service utilization, 6 month	Primary Outcome, Skilled delivery service utilization, Pre-and post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	11/11/2025	Review comment	Secondary Outcome, Husbands’ knowledge on obstetric danger sign, 6 month	Secondary Outcome, Husbands’ knowledge on obstetric danger sign, Pre-and post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Outcome	OutCome List	11/11/2025	Review comment	Secondary Outcome, Husbands’ attitude towards their involvement on maternity continuum of care, 6 month	Secondary Outcome, Husbands’ attitude towards their involvement on maternity continuum of care, Pre-and post-intervention
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	11/11/2025	Review comment	TRUE, Wolaita Sodo University Institutional Review Board, Woalita Sodo Unversity, Sodo, 138 , Ethiopia, , 02 Oct 2025, +251912274086, bt.lnsk@gmail.com, 38472_35649_4737.pdf	TRUE, Wolaita Sodo University Institutional Review Board, Woalita Sodo Unversity, Sodo, 138 , Ethiopia, , 02 Oct 2025, +2510465511911, dawitdalga9@gmail.com, 38472_35649_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Maximum age	11/11/2025	Reason that I have ticked both age groups (19 year -44 year and 45 year-64 year) is that husbands with age of 19 years- 64 were participants in the trial.	65 Year(s)	64 Year(s)

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