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.: PACTR202204658979734 Date of Approval: 04/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF MOBILE PHONE TELE-REMINDER ON IRON STATUS AND DIET QUALITY OF PREGNANT WOMEN AVAILING ANTENATAL CARE AT PHEBE AND CHARLES B. DUNBAR HOSPITALS, BONG COUNTY, MONROVIA-LIBERIA A CLUSTER RANDOMIZED CONTROL TRIAL
Official scientific title A cluster trial of the effects of mobile-phone tele-reminder on iron status and diet quality of pregnant women availing antenatal care at Phebe and Charles B. Dunbar hospitals, Bong County, Monrovia-Liberia
Brief summary describing the background and objectives of the trial Unfortunately, the majority of pregnant women in Sub-Saharan Africa are denied access to antenatal care, increasing their risk of pregnancy-related mortality and morbidity (Zhongming et al, 2010). According to the most recent Liberia Demographic and Health Survey (DHS 2019), 45 percent of Liberian women are anemic, including 23 percent mildly anemic, 21 percent moderately anemic, and 1 percent seriously anemic. Rural areas have a greater frequency of anemia (47%) than cities (43 percent). Only 43% of pregnant women took iron supplements for at least 90 days, while 64% took deworming medication. Iron supplementation was not taken by 6% of pregnant women (DHS 2019). Objective: The objective is to reduce anemia in pregnancy through the application of mobile phone-based teleconsultation in delivering antenatal care services to pregnant women on the start of their first antenatal care visit at Phebe and Charles B. Dunbar Hospitals, Bong County-Liberia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 Prevention
Anticipated trial start date 01/06/2022
Actual trial start date 01/06/2022
Anticipated date of last follow up 02/09/2022
Actual Last follow-up date 30/11/2022
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard or Routine antenatal care Routine ANC for the duration of 3 months 3 months All respondents assigned to the control group will receive routine and standard ANC services. Respondents in this group will be follow-up every month to measure the primary and secondary outcome variables. During every ANC visit, routine ANC will be administered by the assigned midwives. The primary outcome variables that will be measured will include hemoglobin, diet diversity score, and adherence to all routine ANC services. The secondary outcome variables that will be of interest in this study will be hand hygiene practices, malaria smear, level of ANC satisfaction, and body weight in kg. 75 Active-Treatment of Control Group
Experimental Group Mobile phone based teleconsultation by means of SMS and phone call Biweekly teleconsultation 3 months In the experiment group, each respondent will receive intervention slightly different from those administered to the respondents assigned to the control group. The key differences in terms of intervention will include: 1. Respondents in the experiment group will receive mobile phone-based teleconsultation biweekly while at their various homes. During the nutrition intervention, the focus will not be on all the various food groups but rather, respondents will be counseled only on food groups with rich sources of iron and vitamins that enhance iron absorption. Respondents in this group will be assisted via visual aid with a list of affordable, available, and accessible locally produced foods (identified in the West African Food Composition Table, 2012) that are good sources of iron and vitamins. The Mobile Phone Teleconsultation Manual (Appendix D) developed by the researcher, for us, the midwives will be used as a guide in administering the consultation to the respondents. 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
In a cluster randomized control trial, the eligibility criteria will be applied to the hospitals and the individual level of analysis. Hospitals with the highest antenatal care attendance, equip medical and laboratory facilities and more screening facilities for ANC will be selected for this study. Phebe and the Charles B. Dunbar hospitals are two centrally referral hospitals located in Liberia with a high level of ANC attendance. These two hospitals will be selected because they provide all the minimum recommended ANC services (drugs availability, laboratory standard, and so on). At the individual level, pregnant women availing ANC for the first time at the selected hospitals will be the sample population. Additionally, Pregnant women with no chronic medical problems, those accessible via mobile phone, and those who are willing to sign the consent form will be eligible for this study. A total of 147 pregnant women will take part in this study. Seventy-five (75) pregnant women will be assigned to each treatment arm. As exclusion criteria, all pregnant women who have had prior ANC visits, those with chronic health-related problems in pregnancy, those who are not reachable via mobile phone, and finally those who will refuse to sign the consent form. Pregnant women who have had prior ANC visits will be excluded because they have been exposed to other ANC interventions that could affect the outcome variables Adult: 19 Year-44 Year 19 Year(s) 44 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 01/04/2022 National Research Ethic Board of Liberia
Ethics Committee Address
Street address City Postal code Country
21 Street, Sinkor, JFK Compound, Monrovia Liberia Monrovia 50101 Liberia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The control intervention will consist of routine/standard antenatal care services. The experimental intervention will consist of mobile phone calls and short messages services (SMS). The primary outcome will be the difference in the average iron status (measured as hemoglobin) between the control group and the intervention group. The indicator for measuring iron status in this study will be hemoglobin measured in g/dl. The cutoff point for normal hemoglobin in pregnancy is >12g/dl. Anemia is considered as hemoglobin level <11g/dl. At each monthly ANC visit
Secondary Outcome The secondary outcomes will include the prevalence of malaria infection in the control group and the intervention group, the difference in hygiene and health practice between the control group and the intervention group, and the prevalence of pregnant women consuming at least one or more iron-rich food in the control and intervention groups. The time, methods, and frequency of handwashing will be used to evaluate hygiene practices. Malaria Smear or the Rapid Diagnostic Test (RDT) will be used to determine the presence or absence of malaria infection. The Food Frequency 66 Questionnaires will be used to evaluate dietary practices among pregnant women in the control group and those also in the intervention group. At each monthly ANC visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Phebe and Charles Dunbar Hospitals Bong County, Liberia Gbarnga City Liberia
FUNDING SOURCES
Name of source Street address City Postal code Country
Washington Kezelee Phebe Airstrip, Suakoko District, Bong County, Liberia Gbarnga City Liberia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Henry Y. Kezelee Zuwulor Town, Zorzor District, Lofa County- Liberia Zorzor City Liberia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Washington Kezelee wkezelee@up.edu.ph +231778948505 Phebe
City Postal code Country Position/Affiliation
Gbarnga City Liberia PhD Student
Role Name Email Phone Street address
Public Enquiries Leila S. Africa lsafrica@up.edu.ph +639612316221 University of Philippines Los Banos
City Postal code Country Position/Affiliation
Los Banos Philippines Research Advisor
Role Name Email Phone Street address
Scientific Enquiries Corazon V.C Barba corazonbarba@gmail.com +639221348631 Laguna
City Postal code Country Position/Affiliation
Los Banos Philippines Cochair of my research committee
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IDP DATA SHARING STATEMENT Questions Statement 1. Will individual participant data be available? yes 2. What data, in particular, will be shared? All of the individual participant data collected during the trial, after deidentification 3. What other documents will be available? The study protocol and the informed consent form 4. When will data be available? immediately the following publication. No end date 5. Data will be shared for what purpose of analysis? To achieve the aim of the approved proposal 6. By what means data will be shared? Data are available indefinitely at (Link to be included in the PI) Informed Consent Form,Study Protocol Immediately after the publication The result will open access.
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