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.: PACTR201812621823801 Date of Approval: 21/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Couple Counseling on use of Modern Family Planning , in Eastern Ethiopia
Official scientific title Effect of Couple Counseling on the use of Modern Family Planning among currently married women in Eastern Ethiopia, Randomized Control Trial
Brief summary describing the background and objectives of the trial Family planning is unique in its range of potential benefits, encompassing economic development, maternal and child health, educational advances, and women’s empowerment. With the control over their own fertility desires, women can help improve both their health and career aspirations. Unless male is involved into the family planning counseling, women's desire to limit or space the birth will not be achieved as planned by government. Despite the role of husband in decision making of family planning methods, little is factually known about the effect of couple counseling on modern family planning uptake among couples. Hence this study should generate evidence on the effectiveness of couple counseling for the initiation and uptake of modern family planning methods. The objective of this trial is to evaluate effect of couple counseling on modern family method use among currently married reproductive aged women in rural areas of Eastern Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Effective use of modern family planning
Purpose of the trial Prevention
Anticipated trial start date 01/01/2019
Actual trial start date 01/02/2019
Anticipated date of last follow up 01/07/2019
Actual Last follow-up date 30/07/2019
Anticipated target sample size (number of participants) 594
Actual target sample size (number of participants) 594
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group women alone family planning counselling 6 times 6 month a total of six family planning counseling(intervention counselling) session will be given for the women without their husbands on monthly basis 198
Experimental Group couple family planning counselling 6 times 6 months family planning counseling session for couples(women with their husbands) given on monthly basis for a total of six times 198
Control Group standard care The control group will be visited for two times only (at base line and end line data collection period) The women in this group will receive standard care only(offered by existing health extension workers) 198 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
non pregnant women currently married women living with their husband Husbands or wives who were cognitively impaired or in very poor health husbands or wives reporting infertility Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 03/07/2018 HARAMAYA UNIVERSITY COLLEGE OF HEALTH AND MEDICAL SCIENCES INSTITUTIONAL HEALTH RESEARCH ETHICS REVIEW COMMITEE
Ethics Committee Address
Street address City Postal code Country
Bote, Harar Harar 00235 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Modern family planning method uptake at baseline and at end of the intervention
Secondary Outcome knowledge of modern family planning methods at base line and at end line of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Babile Babile, Eastern Ethiopia Harar 00235 Ethiopia
Kombolcha kombolcha, Eastern Ethiopia kombolcha Ethiopia
Kersa kersa, Eastern Ethiopia kersa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Center for International Reproductive Health 300 North Ingalls Street, Suite 947 Michigan United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Center for International Reproductive Health Training 300 North Ingalls Street, Suite 947 Michigan United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Center for International Reproductive Health Training 300 North Ingalls Street, Suite 947 Michigan United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Teshale Mulatu teshalem19@gmail.com 251921867010 Bote,harar, Eastern Ethiopia
City Postal code Country Position/Affiliation
Harar 00235 Ethiopia lecturer department of Midwifery Haramaya university college of health and medical science
Role Name Email Phone Street address
Public Enquiries Merga Agga mderesa@yahoo.com 251912031784 Harar, Bote
City Postal code Country Position/Affiliation
Harar 00235 Ethiopia Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Yadeta Bacha yad_de2005@yahoo.com 251911741054 Bote, Harar
City Postal code Country Position/Affiliation
Harar 00235 Ethiopia Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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