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.: PACTR202202775997127 Date of Approval: 28/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of public health education on the uptake of iron-and folic acid supplements among pregnant women
Official scientific title Effectiveness of public health education on the uptake of iron-and folic acid supplements among pregnant women in Embu county: A stepped wedge cluster randomized trial
Brief summary describing the background and objectives of the trial Iron deficiency is the most prevalent and devastating micronutrient deficiency in pregnancy globally responsible for nearly 120,000 maternal deaths per year and nearly a fifth of the burden of maternal mortality. Over 46% of pregnant women in Africa and South-East Asia and over half (62%) of pregnant women in Kenya are anemic. This has severe economic and health consequences. Micronutrient supplementation with iron and folic acid is an efficacious strategy recommended in pregnancy to reduce the risk of anemia and improve maternal and neonatal survival. However, most pregnant women do not consume iron and folic acid supplements (IFAS) as recommended. The current recommendation is daily IFAS throughout pregnancy. Nonetheless, disparate factors have contributed to the poor consumption, especially limited knowledge on IFAS, its benefits and its connection with anemia, and the mitigation of its side effects. The importance of awareness as a dimension of access has been documented, but there is no evidence on the efficacy of public health education on prenatal IFAS uptake. The purpose of this maternal IFAS awareness (MIA) study is to determine the efficacy of IFA awareness on antenatal IFAS uptake using a stepped wedge cluster randomized trial with antenatal clinics as the units of randomization. The clusters will be randomized to receive an IFAS awareness package and their levels of IFAS uptake compared with the pre-intervention performance. A total of 12 clusters will be recruited to participate in the 9-month trial effectively enrolling 1,205 pregnant women in Embu County. Respondents’ socio-demographics and their knowledge, attitudes and practices (KAP) towards IFAS will also be assessed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MIA
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date 31/03/2023
Anticipated target sample size (number of participants) 12
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Current practice During every clinic visit Throughout the control period until the cluster transitions to intervention phase. The duration of the control period will vary per cluster depending on the randomization sequence. No change will be made on the current standard of care provided to pregnant women seeking antenatal care services. Pregnant women will be given health education in group sessions covering general topics relating to pregnancy, the woman will then go to examination rooms for physical examination, the health worker will update her on the progress of her pregnancy and inform her about her next clinic visit. In addition, the health worker updates the visit details in the Ministry of Health register for antenatal care (MoH 405). Finally the woman goes to the pharmacy unit at the clinic where she receives iron and folic acid supplements (if they are available) and goes home. The process is repeated during every clinic visit. 12 Historical
Experimental Group MIA study public health education bundle Daily. During every visit to antenatal care clinic Daily. Throughout pregnancy period. The intervention bundle consists of the following elements for the various audiences: Health workers: (1). Reorientation covering overview of rationale for iron and folic acid supplements (IFAS ), dosing schedule, pill reminder card (PRC), (2) Provide MoH flipcharts with key points to use during health talks and guide on it's usage, (3) Provide MoH algorithm for counselling on antenatal IFAS. Pregnant women: (1) Morning health talks on risk of anemia in pregnancy, IFAS benefits and dosing, mitigation of IFAS side effects, (2) Emphasis on ANC return dates for IFAS refill reinforced through wall calendars with well-marked return dates for antenatal clinic (ANC), (3) Pill reminder cards and guidance on their utility to facilitate continuous IFAS uptake. Crosscutting: (1) MoH wall charts with messages on antenatal IFAS provided to all participating clinics, (2) Sufficient supply of IFA supplements, (3) Health facility audits and feedback by study and county team. 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following eligibility criteria will be used for ANC clinics: (i) Health facilities enrolling at least 21 new pregnant women per month. (ii) Facilities with complete health records (ANC register and bin cards). (iii) Facilities receiving MoH IFAS supplies. (iv) Willingness of facility management and staff to participate in the study. (i) Antenatal clinics whose management will not consent to participate. (ii) Pregnant women receiving care from non-consenting health facilities. (iii) Pregnant women under the age of 15 years. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 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
No 26/01/2022 Kenyatta University Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Centre for Research Ethics and Safety Nairobi 00100 Kenya
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 25/02/2022 Kenyatta University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Kenyatta University Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of pregnant women effectively taking up IFA supplements. End of trial
Secondary Outcome None. Decision to limit the measurement to primary outcome only. None. Decision to limit the measurement to primary outcome only.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Embu County Health Department Office Off Kaunda Street Embu Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Haron Njiru Thogoto Gikambura Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta University Kenyatta University Main Campus Juja Kenya University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haron Njiru njiru@outlook.com +254720114640 Thogoto Gikambura
City Postal code Country Position/Affiliation
Nairobi Kenya Student at Kenyatta University
Role Name Email Phone Street address
Scientific Enquiries Eunice Njogu njogu.eunice@ku.ac.ke +254722862052 Kenyatta University Main Campus
City Postal code Country Position/Affiliation
Juja Kenya Lecturer Kenyatta University
Role Name Email Phone Street address
Public Enquiries Mary Gitahi gitahi.mary@ku.ac.ke +254722934732 Kenyatta University Main Campus
City Postal code Country Position/Affiliation
Juja Kenya Chair Department of Community Health Kenyatta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data Sharing statement: All the individual participant data collected during the trial will be made available after deidentification. The other documents that will be made available is the study protocol. These will be available immediately following publication of the study findings. This data will be made available to Investigators whose proposed use of the data has been approved by an independent review committee. The recipients will be allowed to use the data for the approved purposes only. Request to access the data should be directed to njiru@outlook.com Results Reporting: The results of this trial will be disclosed to the public as required by the World Health Organization (WHO). The summary summary results of this randomized controlled trial will be reported within a year from completion of the trial. The report covering all the 9 items stipulated in the 18 May 2017 Joint statement on public disclosure of results from clinical trials. Study Protocol 01 November 2022 with no end date. Data will be accessible to Investigators whose proposed use of the data has been approved by an independent review committee.
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