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.: PACTR202105600194030 Date of Approval: 19/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of proactive counseling on postpartum family planning utilization among women who gave birth at health institutions in Harari region, eastern Ethiopia
Official scientific title The effect of proactive counseling on postpartum family planning utilization among women who gave birth at health institutions in Harari region, eastern Ethiopia
Brief summary describing the background and objectives of the trial Postpartum family planning (PPFP) is a key strategy for purposes of spacing and limiting childbirths in 2 years after delivery which also reduces maternal and newborn morbidity and mortality. Ethiopia is far away from a set target to meeting the PPFP demand by 2020 and Harari region is one of the country’s settings with the highest unmet need of PPFP. .This study was aimed to examine the effect of proactive counseling on PPFP utilization and its associated factors among institutionally delivered women in Harari region, eastern Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/04/2020
Actual trial start date 01/04/2020
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 333
Actual target sample size (number of participants) 333
Recruitment status Completed
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Proactive Counseling six month For postpartum women we recruited from Hiwot Fana Specilized University Hospital as intervention arm, we provided a proactive counseling of FP ahead of the data collection. The intervention protocol we employed was the national family planning counselling tool which included details of rapport, exploration, decision making, and implementation (REDI) framework. This means, we applied the existing national FP counseling tool proactively on women who delivered at the hospital. As a counseling procedure, we strictly followed the REDI framework. To accomplish the counseling intervention, experienced healthcare professionals were recruited, trained and assigned to each maternity ward to counsel the postpartum women as per the REDI framework before they were discharged from the wards. A validated questionnaire which contained all information regarding socio-demographic, reproductive health history, contraceptive knowledge and FP utilization was employed for data collection. The data collection approach was an interviewer administered for baseline assessment in the hospital. For follow-up assessments, however, the postpartum women were interviewed by telephone calls two times at 6th week and 6th month intervals after delivery. For the intervention group, the postpartum women were interviewed for their fertility desire, willingness to space child, and willingness to limit childbirth following the counseling intervention. The contraceptive information and counseling intervention details consisted of types of contraceptive methods and their effectiveness, advantages, disadvantages, risks, adverse effects and proper use. For women who decided to use PPFP methods at the moment, the data collectors linked them with healthcare providers so as to give them with their contraceptive method of choice 188
Control Group No proactive counseling six For the control group, we did not give any form of intervention other than the usual services and counseling provided at the hospital. Accordingly, women assigned to control group were simply interviewed by the data collectors about their desire for fertility and intention to use PPFP. Overall, women who had not used FP before discharge from the hospitals were interviewed twice (i.e., at 6th week and 6th month after delivery) by telephone calls to check whether they have already used the FP from the same facility or elsewhere or not. 145 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women who gave birth at the hospitals and who were in postpartum period during the data collection time were considered for inclusion in the study. Women who had a known learning difficulty or mental health problem, and who did not need contraception (e.g., women with hysterectomy) were excluded. Adult: 19 Year-44 Year 15 Year(s) 40 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 17/03/2020 Haramaya University College of Health and Medical Sciences Institutional Health Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Harar Botte Harar 235 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Not applicable Not applicable
Primary Outcome post partum family planning utilization at 1st day 6 week and 6 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Public Hospital in Harari Region Andegna Menged Harar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Engender Health Bole Medianalem Addisa Ababa 156 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Haramaya University College of Health and Medical Sciences Botee street Harar 235 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Mihiret Habite Bole Medihaniyalem Addis Ababa Ethiopia
Dumessa Edessa Bote street Harar Ethiopia
Yadeta Dessie Bote street Harar Ethiopia
Eshetu Girma Tikur Anbessa Addisa Ababa Ethiopia
Alexander Mohammed Bote street Harar Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Yadeta Dessie yad_de2005@yahoo.com +251930179948 Bote street
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Chief Executive Directors of Health and Medical Science College
Role Name Email Phone Street address
Principal Investigator Merga Dheresa mderesa@yahoo.com +251912031784 Botee street
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Assistant professor of Maternal and Public Health
Role Name Email Phone Street address
Scientific Enquiries Nega Barki neggalemash@gmail.com +251254662011 Batee street
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Chair Person for Institutional Health Research Ethics Review Committee
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share Individual participant data that underlie the results reported in this article (Study protocol, Statistical Analysis Plan, Analytic Code), after deidentification (text, tables, figures, and appendices) to anyone who wishes to access the data for any purpose within Immediately following publication, no end date. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Impact of proactive counseling on post partum family planning utilization
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/04/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/04/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information