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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609669836522 Date of Registration: 08/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of partner counselling on the quality of life of women with obstetric fistula in Katsina Nigeria : A randomised controlled trial
Official scientific title Impact of partner counselling on the quality of life of women with obstetric fistula in Katsina Nigeria : A randomised controlled trial
Brief summary describing the background and objectives of the trial Woman suffering from obstetric fistula suffer not only from the physical effects of their illness but also undergo devastating psycho-social problems as identified by numerous studies. These effects include loss of marriage (divorce), depression, stigma, low self-esteem, discrimination and abandonment. Men have great role to play in caring for women with VVF by ensuring they have access to medical care where the physical and psychosocial problems are attended to. Access to maternity care is largely dependent on the husbands as many women in northern Nigeria lack autonomy to decide when and how to access the health care facility. Aim. This study intends to find out if involvement of men in the form of counselling to the partners of obstetric fistula patients will affect the quality of life of the women
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 13/09/2026
Actual trial start date
Anticipated date of last follow up 30/04/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL not yet published
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group counselling of partners of obstetric fistula patients one-on-one counselling of the male partners 15 to 30 minutes The partners of the study participants that fall under intervention group will be invited at their convenience for an individual counselling session. Each spouse will be counselled once. The counselling will be provided by two certified counsellors from the social welfare department. The content of the counselling includes the importance of antenatal care, supervised delivery, prolong labour and other causes of obstetric fistula, importance of support for obstetric fistula patients and follow up 40
Control Group no intervention just standard of care None just standard of care none standard of care 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Obstetric fistula patients who are married at the time of presentation who are on admission. Non consenting women Divorced, widowed or separated women Women with history of back ground psychiatric disorder Husbands refusal to participate even if the woman is eligible Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 64 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 18/08/2026 NOFICK ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Babbar ruga , Batsari road Batagarawa LGA Katsina Katsina 820001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improvement in the WHO bref quality-of-life score 6 month post intervention
Secondary Outcome adherence to follow up and continuous financial and psychological support from the husband 6 month post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National obstetric Fistula Centre Katsina Babba ruga, Batsari road Katsna katsina state 820001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hurera Umar Kofar sauri Katsina Katsina State Nigeria 820001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hurera Umar Kofar Sauri Katsina Nigeria Katsina State Nigeria 820001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hurera Umar humardarma@yahoo.com +2348065532272 Kofar Sauri Katsina State Nigeria
City Postal code Country Position/Affiliation
Katsina State 8200001 Nigeria Consultant Obstetrician and Gynaecologist at NOFIC Katsina
Role Name Email Phone Street address
Public Enquiries Yusuf Shuaibu naiyabab@yahoo.com 23435923946 NOFICK Katsina
City Postal code Country Position/Affiliation
Katsina 820001 Nigeria Obstetrician Gynaecologist NOFIC Katsina
Role Name Email Phone Street address
Scientific Enquiries Jamilu Tukur jtukur@yahoo.com +2348037042818 AKTH Kano
City Postal code Country Position/Affiliation
Kano Nigeria 700001 Nigeria Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available this include all individual data collected during the trial without identification of the individual participant Documents to be shared include study protocol Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available one year after the publication up to 3 years data will be shared with researchers that want to access it for an approved research
URL Results Available Results Summary Result Posting Date First Journal Publication Date
A link will be provided through email 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 Public title 01/09/2026 Correction made by the reviewer IMPACT OF PARTNER COUNSELLING ON THE QUALITY OF LIFE OF WOMEN WITH OBSTETRIC FISTULA IN KATSINA NIGERIA : A RANDOMISED CONTROLLED TRIAL Impact of partner counselling on the quality of life of women with obstetric fistula in Katsina Nigeria : A randomised controlled trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 01/09/2026 Correction made by the reviewer IMPACT OF PARTNER COUNSELLING ON THE QUALITY OF LIFE OF WOMEN WITH OBSTETRIC FISTULA IN KATSINA NIGERIA : A RANDOMISED CONTROLLED TRIAL Impact of partner counselling on the quality of life of women with obstetric fistula in Katsina Nigeria : A randomised controlled trial
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/09/2026 corrections Experimental Group, counselling of partners of obstetric fistula patients, one-on-one counselling of the male partners, 15 to 30 minutes, The partners of the study participants that fall under intervention group will be invited at their convenience for an individual counselling session. Each spouse will be counselled once. The counselling will be provided by two certified counsellors from the social welfare department. The content of the counselling includes the importance of antenatal care, supervised delivery, prolong labour and other causes of obstetric fistula, importance of support for obstetric fistula patients and follow up, 40,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/09/2026 Corrections by the reviewer. How ever there is no separate column on this form for the control group Control Group, no intervention which is individual partner counselling the group but they receive standard of care, None just standard of care, none, no intervention to control group, 40, Active-Treatment of Control Group Control Group, no intervention just standard of care, None just standard of care, none, standard of care, 40, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/09/2026 Corrections by the Trial reviewer TRUE, NOFICK ethics Committe, Babbar ruga , Batsari road Batagarawa LGA Katsina, Katsina, 820001, Nigeria, , 18 Aug 2026, +23431259264, nofickatsina@gmail.com, 44957_40286_4737.pdf TRUE, NOFICK ethics Review Committee, Babbar ruga , Batsari road Batagarawa LGA Katsina, Katsina, 820001, Nigeria, , 18 Aug 2026, +23431259264, nofickatsina@gmail.com, 44957_40286_4737.pdf