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.: PACTR202007617885299 Date of Approval: 10/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nutritional intervention to reduce the burden of anemia during pregnancy
Official scientific title Community-based maternal nutritional intervention to reduce the burden of anemia during pregnancy in peri-urban areas of Dodoma City
Brief summary describing the background and objectives of the trial Anaemia during pregnancy is a public health problem and considered as a key risk factor for an adverse outcome of pregnancy. It has been associated with maternal and perinatal mortality, premature delivery, low birth weight and intrauterine growth retardation (WHO, 2014; Gebre & Mulugeta, 2015). Dodoma region is among the regions in Tanzania with high prevalence (63.8%) of anaemia in pregnant (Tatala et al., 2002). Tanzania has implemented various interventions to reduce the burden of anaemia during pregnancy; including anaemia screening and treatment, FeFo supplementantation, deworming, IPTp, provision of ITNs and health education. However, these interventions target pregnant women who attend at the antenatal care services. In Tanzania, utilization of martenal health care services is low (Magoma et al., 2010). According to TDHS-MIS, 2016 report, only 24 % of women had their first ANC visits in the first trimester while 73.5% of women attended ANC in the second and third trimesters of pregnancy. This translates to less opportunity for receiving regular scheduled checkups and interventions to pregnant women, hence increased risk for anaemia. Despite these efforts, the prevalence of maternal anemia has not declined. This may be due to the fact that these interventions are based at the health care facility level hence the uptake at community is limited. There is a need to scale up these interventions at community level, the gap which this project is going to bridge. Therefore the aim of this study is to conduct a community based maternal nutrition intervention to reduce the burden of anaemia among pregnant women in Dodoma peri-ubarn areas.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Anemia in pregnancy
Purpose of the trial Prevention
Anticipated trial start date 28/06/2020
Actual trial start date 28/06/2020
Anticipated date of last follow up 01/10/2020
Actual Last follow-up date 25/10/2020
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 360
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community maternal nutritional education fesolate supplementation deworming and malaria prophylaxis Nutritional education once per month 200mg of dried ferrous sulphate Bp plus 0.25mg Folic acid supplements daily 1500mg of Sulfadoxine plus 75mg of Pyrimethamine in three tablets given on 20th and 24th week of gestational age Mebendazole 400mg start Nutritional education - three months 200mg of dried ferrous sulphate Bp plus 0.25mg Folic acid- three months Malaria prophylaxis - 20th and 24th week of gestational age Deworming - once i) Maternal nutritional education Researchers will develop education materials and deliver them to pregnant women in the interventional group. The educational materials will consist of information on dietary practices to prevent anaemia, risk factors and effects of anaemia during pregnancy. Nutrition education will be delivered three sessions; Firstly nutrition education will be delivered in groups of ten to eleven participants. Each participant will be provided with the developed educational materials as part of self learning. Secondly, each woman will be followed immediately after the first session and given the same training individually. Lastly, individualized follow up training session will be done at the mid of the intervention. ii) Supplementation of Iron and Folic acid tablets All participants in the interventional and control group will be given supplements of iron and folic acid as per national guideline in the course of whole pregnancy. Research assistants will give health education on the importance of taking iron supplement during pregnancy. Monitoring of adherence to iron and folic acid supplementation will be done twice monthly up the end of the project. iii) Malaria prophylaxis All participants in the interventional and control group will be given intermittent prophylaxis treatment for malaria (IPTp) with sulfadoxine pyrimethamine (SP) from 20 – 32 weeks gestation as per national guideline. Research assistants will give health education on the importance of taking IPTp during pregnancy. The first IPTp will be given as soon as we confirm their gestation age and the second dose will be given accordingly. iv) Deworming All participants in the interventional and control group will be given the dose of antihelminthiasis as per national guideline. Research assistants will give health education on the importance of taking antihelminthiasis during pregnancy. 200
Control Group Community based maternal intervention on fesolate supplementation deworming and malaria prophylaxis 200mg of Ferrous Sulphate Bp plus 0.25mg of folic acid supplement daily 1500mg of sulfadoxine plus 75mg of pyrimethamine given on 20th and 24th week of gestational age 400mg of mebendazole start 200mg of Ferrous Sulphate Bp plus 0.25mg of folic acid supplement daily 1500mg of sulfadoxine plus 75mg of pyrimethamine given on 20th and 24th week of gestational age 400mg of mebendazole once i) Supplementation of Iron and Folic acid tablets All participants in the interventional and control group will be given supplements of iron and folic acid as per national guideline in the course of whole pregnancy. Research assistants will give health education on the importance of taking iron supplement during pregnancy. Monitoring of adherence to iron and folic acid supplementation will be done twice monthly up the end of the project. ii) Malaria prophylaxis All participants in the interventional and control group will be given intermittent prophylaxis treatment for malaria (IPTp) with sulfadoxine pyrimethamine (SP) from 20 – 32 weeks gestation as per national guideline. Research assistants will give health education on the importance of taking IPTp during pregnancy. The first IPTp will be given as soon as we confirm their gestation age and the second dose will be given accordingly. iii) Deworming All participants in the interventional and control group will be given the dose of antihelminthiasis as per national guideline. Research assistants will give health education on the importance of taking antihelminthiasis during pregnancy. 200 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women in the second trimester stage of pregnancy (16 – 24 weeks of pregnancy) Pregnant women in the first and third trimester Pregnant women in the second trimester with chronic diseases (HIV, Diabetes, sickle cell anemia) Pregnant women who will not reside in study area up to the end of the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 50 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 30/04/2020 The University of Dodoma Institutional Research Review Committee
Ethics Committee Address
Street address City Postal code Country
Iyumbu Dodoma 0255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduce the prevalence of anaemia After Three months
Secondary Outcome Increase knowledge on Anaemia prevention After Three months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bahi District Bahi peri-urban areas Dodoma United Republic of Tanzania
Chamwino District Chamwino peri-urban areas Dodoma United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The University of Dodoma Iyumbu Dodoma 0255 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The University of Dodoma Iyumbu Dodoma 0255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mariam Munyogwa munyogwam@yahoo.com +2557680494847 Kikuyu
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Lecturer The University of Dodoma
Role Name Email Phone Street address
Public Enquiries Ambrose T. Kessy Kessy akessy99@yahoo.com +255767574466 Iyumbu
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Senior Lecturer The University of Dodoma
Role Name Email Phone Street address
Scientific Enquiries Ipyana Mwampagatwa imwampagatwa@yahoo.com +255758213612 Iyumbu
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania Professor The University of Dodoma
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets that will be used and/or analysed during the study will be available from the principle investigator upon request without any restriction Informed Consent Form,Statistical Analysis Plan,Study Protocol December 2020 to November 2021 The dataset will be available to all scholars upon request from principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.udom.ac.tz 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