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.: PACTR201801002909246 Date of Approval: 24/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of a counseling Intervention on Risk of IPV in Pregnant women in Nigeria
Official scientific title The Effect of a clinic based counselling Intervention on Risk reduction of Intimate Partner Violence among Pregnant women attending Antenatal Clinics of Jos UNiversity Teaching Hospital- a Randomized Controlled Trial
Brief summary describing the background and objectives of the trial IPV has become a very topical issue in Nigeria and the world. In Nigeria, there is a general reluctance to expose the menaace and an acceptance of IPV as a way of life. This puts the pregnant woman at high risk for birth complications and mortality. The study aims to test the effect of a counselling intervention in the antenatal clinics on reduction of the risk of these woman and therefore prevent IPV from occurring. it is hoped that this intervention, if useful, would be introduced into routine antenatal care in order to reduce the burden of IPV in pregnancy and improve birth outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Intimate Partner Violence
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 29/12/2017
Actual trial start date
Anticipated date of last follow up 29/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
Recruitment status Not yet 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 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 15 minutes monthly 3 months empowerment counselling 48
Control Group IPV screening and risk assessment monthly 3 months IPV screening and risk assessment 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All clients attending ANC in JUTH within the study period who are at least 18 years of age, with gestational ages 24 weeks or less, calculated from last menstrual period or earliest obstetric Ultrasound scan done, and have given consent to participate in the study. All pregnant women are included because they are all considered to be at risk of IPV since pregnancy, by itself, is a risk factor for IPV. 1. ANC attendees who are acutely ill as their need for care will be prioritized and they may not be able to respond to the questions. 2. ANC attendees whose partners have insisted on being present at the interview as that may cause them to withhold or falsify information. 3. ANC attendees who plan to relocate within the 12 week study period as follow up may become difficult when they do so. 4. ANC attendees who do not have intimate partners as that precludes them from suffering from IPV; for example, attendees who do not have intimate partners but got pregnant from rape by a stranger or other persons with whom she is not intimate. 18 Year(s) 99 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 02/11/2016 Institutional Health Research Ethical Committee, Jos University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Lamingo Jos 930001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean IPV risk (measured by Danger assessment score) At baseline After 3 months
Secondary Outcome Prevalence of IPV At baseline at 1 month at 2 months at 3 months
Secondary Outcome demographic characteristics at baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Antenatal clinic, Jos University teaching Hospital Lamingo Jos 930001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self funded Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
none
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tochukwu Uchendu tachukwu@yahoo.com +2347032282996 Lamingo
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Senior Registrar/ JUTH
Role Name Email Phone Street address
Public Enquiries Tochukwu Uchendu tachukwu@yahoo.com +2347032282996 Lamingo
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Senior Registrar/ JUTH
Role Name Email Phone Street address
Scientific Enquiries Tochukwu Uchendu tachukwu@yahoo.com +2347032282996 Lamingo
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Senior Registrar/ JUTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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