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.: PACTR202107529608380 Date of Approval: 22/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of family planning education
Official scientific title The effect of couple based family planning education on reversible modern contraceptive use continuation among married couples of reproductive age in Jimma Zone
Brief summary describing the background and objectives of the trial Among the proximate determinants of fertility, contraceptive use is found to play significant role in population stabilization by reducing total fertility rates, thereby enhancing economic development, lowering maternal morbidity and mortality by preventing pregnancies that are too early, too close, too many, or too late, and high risk births which could pose adverse health consequences for the mother, child, and the family (FMOH, HPP, PPD ARO, USAID, 2012). Though there has been relative contraceptive prevalence rate increase in Ethiopia, the reduction in fertility rate is very low attributed to various reasons .among which the couple level variables affecting the contraceptive use dynamics (such as adequate awareness about FP/Contraception, inter-spousal communication, partner contraceptive use approval and support, contraceptive use discontinuation and its covert use) among other multifaceted factors can be considered(JO et al., 2014, MOH, 2003),. Most studies on contraceptive use mainly focus on prevalence, determinant factors of use and cross sectionals in their designs and there are little theory or based longitudinal studies which addresses the effect of family planning education on reversible modern contraceptive use continuation, inter-spousal communication, partner approval and support, and covert contraceptive use among married couples of reproductive age groups. The study findings will have significant contribution in the efforts made to improve maternal and child health by various stakeholders like Federal ministry of health, Program managers, at various levels of health sectors and policy makers Thus, using the information motivation behavioral skill model, this study aims to determine the effect of couple based family planning education on reversible modern contraceptive use, inter-spousal communication, partner approval and support, and covert contraceptive use and method choice among married couples of Jimma Zone, South West Ethiopia. Specific objectives 1. The effect of couple based family planning education on knowledge, attitude and practice towards family planning use among married couples of reproductive age group in Jimma Zone 2. The couple based family planning education: The extent of changes in covert contraceptive use, and method choice among married women of reproductive age 3. The couple based family planning education: The extent of changes in covert contraceptive use, and method choice among married women of reproductive age 4. The effect of couple based family planning education on modern reversible contraceptive use continuation among married women of reproductive age in Jimma Zone
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Family planning
Purpose of the trial Education /Training
Anticipated trial start date 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 31/08/2021
Actual Last follow-up date 31/08/2021
Anticipated target sample size (number of participants) 766
Actual target sample size (number of participants) 766
Recruitment status Active, not 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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Family planning education Overall, family planning education was given on three sessions in various settings within two months (January to February). As the distribution of population in the community is disperse, and because of COVID-19, the education was given at an individual bases through home –to-home visit, and in groups of small members (5-10) as convenient. The duration of the intervention was for two months (from January to February, 2021) Family planning education will be given for both the husband and wife on family planning or contraceptive methods,(Concept of family planning, Benefits, existing reversible modern contraceptives methods, side effects, management of side effects, method continuation, importance of male and involvement for effective use of family planning). 383
Control Group Usual counseling service Routine counseling service For two months (January to February, 2021 The control group will be left to the usual routine counseling of the health post or health institution 383 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women of reproductive age (15-49 years) and their partners, who are currently using modern contraceptive methods, lived in the selected kebeles (first level local administrative section) at least for six months, married and living together and have a plan of spacing child birth at least for one year Those who have a plan of leaving the area less than 12 months People of Polygamy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 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 12/07/2020 Jimma University IRB committee
Ethics Committee Address
Street address City Postal code Country
Jimma Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Awareness six months from now
Secondary Outcome Awareness six months from now
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kersa and Goma district Jimma Jimma 5039 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Governmental organization Jimma Jimma 378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma Jimma 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fekadu Yadassa fekadutesso@gmail.com +251912050454 Jimma
City Postal code Country Position/Affiliation
Jimma 5039 Ethiopia Assistant professor
Role Name Email Phone Street address
Public Enquiries Gurmesa Tura gurmesatura@gmail.com +251912061646 Jimma
City Postal code Country Position/Affiliation
Jimma 5039 Ethiopia Associate professor
Role Name Email Phone Street address
Scientific Enquiries Zewdie Birhanu zbkoricha@yahoo.com +251917025852 Jimma
City Postal code Country Position/Affiliation
Jimma 5039 Ethiopia Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data (IPD) will be shared within 12-24 months after publication of the research papers. The individual participant data may include study protocol, statistical analysis plan, informed consent form, Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD may be shared within 12-24 months after publication of the research papers The data can be used for any purpose and will be available on publisher web site or Jimma University data base.
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