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.: PACTR201403000787182 Date of Approval: 11/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Contaceptive utilization
Official scientific title Innovative program to promote contraceptive utilization among mothers in Khartoum State: Study protocol for a randomized controlled trial
Brief summary describing the background and objectives of the trial Although family planning services were initiated in 1965 in Sudan and in 1985 were integrated into the Primary Health Care System, yet utilization rate remains low at 9% which is among the lowest in the World (1). The general objective of the study focuses on identifying the effect of innovative family planning program on contraceptive utilization. Methods: This is a quantitative (Cluster randomized controlled trial) and qualitative mixed study. It will be conducted in Khartoum State from January 2013 to November 2014. It will develop and implement an innovative family planning program by the researcher, trained midwives and community participants. The data will be collected on mothers¿ knowledge and behaviour and family planning utilization rate at pretest and at posttest and then to be compared in addition to identifying the factors and challenges affecting contraceptive utilization, through questionnaire and in-depth interviews. The study population will be defined as any married women in Khartoum State and informed consent will be obtained. The sample size is calculated by using Hayes and Bennett equation to be 200 women for both intervention and control group, and the data collected will be analyzed by means of thematic analysis for qualitative and computerized method SPSS -20.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Contaceptives,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Family planning programme
Purpose of the trial Education /Training
Anticipated trial start date 05/05/2014
Actual trial start date 05/05/2015
Anticipated date of last follow up 31/03/2015
Actual Last follow-up date 02/03/2015
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status 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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Contraceptive once four months The provision of family planning services in primary level will promote the mothers to utilize it. This could be happened by: 1. Training of midwives in primary health care centers through conducting workshops 2. Provision of family planning services at this level of care, which will be done by trained midwives. 3. Enhancing and encouraging mothers at postnatal period about family planning methods 100
Control Group As usual once four months as usual 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Postnatal mothers Attending during data collection period Refused to particpate 20 Year(s) 45 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 25/12/2013 Sumasri
Ethics Committee Address
Street address City Postal code Country
SUMASRI Khartoum 00249 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increase in women's knowledge and behaviour 2 months interval
Secondary Outcome Contraceptive use increas 4 months interval
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Khartoum Health Centers Khartoum Khartoum 00249 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Khartoum Khartoum 00249 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Waled Amen Ahmed Khartoum Khartoum 00249 Sudan Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr. AIda Ahmed Fadalla Khartoum Khartoum 00249 Sudan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ehab Elamin weliameen1980@live.com 0122989400 Khartoum, Tuti Island
City Postal code Country Position/Affiliation
Khartoum 00249 Sudan Assistant Professor
Role Name Email Phone Street address
Principal Investigator Waled Ahmed weliameen1980@yahoo.com 00966508245369 Al-Baha, Almafarijah
City Postal code Country Position/Affiliation
Al-Baha 00966 Saudi Arabia Assistant Professor
Role Name Email Phone Street address
Public Enquiries Raga Ahmed ragy254@yahoo.com 0121480464 Khartoum, Alsahafa
City Postal code Country Position/Affiliation
Khartoum 00249 Sudan Midwife
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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