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.: PACTR202310594848644 Date of Approval: 03/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of maternal and fetal outcomes of intermittent and daily iron supplementation among pregnant women in NAUTH Nnewi, Nigeria: A randomized control study
Official scientific title Comparison of maternal and fetal outcomes of intermittent and daily iron supplementation among pregnant women in NAUTH Nnewi, Nigeria: A randomized control study
Brief summary describing the background and objectives of the trial Iron deficiency anaemia remains the leading cause of anaemia worldwide. This is common especially in developing countries where nutritional deficiency is the major culprit. Pregnancy is associated with increased iron demand and antenatal iron supplementation has been shown to reduce the incidence of iron deficiency in pregnancy with attendant improved maternal and fetal outcomes. The aim of the study is to determine and compare the effects of intermittent versus daily iron supplementation on maternal and fetal outcomes among pregnant women.
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 Prevention
Anticipated trial start date 02/10/2023
Actual trial start date
Anticipated date of last follow up 02/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Daily iron group Participants in the daily iron group will be instructed to take one tablet of 200mg ferrous sulphate daily for 4 weeks Daily iron for 4 weeks and then repeated 4 weekly throughout the duration of pregnancy Participants in the daily iron group will be instructed to take one tablet of 200mg ferrous sulphate daily for 4 weeks. At the end of the 4 weeks period, the tablet pack will be counted and reviewed to check for compliance and the amount taken noted. The regimen will be repeated 4 weekly for the duration of the study for both groups. The participants will be told to take the tablet in the morning when they have empty stomach or at least 30 minutes before meal and not to take it with milk, tea or coffee. In addition, they will be informed to take the iron tablet with Vitamin C for maximum absorption. The will be told to report any side effect like nausea, vomiting, heartburns, diarrhea, constipation etc. The baseline serum haemoglobin, serum ferritin will be measured in all participants at the point of recruitment and repeated twice. The second and third samples will be obtained at 24-28 weeks and 34-36 weeks respectively after commencement of iron supplementation so as to determine the effect of treatment on serum haemoglobin and ferritin respectively. Only samples of participants who take their drugs regularly based on the group she belongs to will be taken and analysed. The participants will be followed up till delivery and the delivery outcomes noted 45
Control Group Intermittent iron group 200mg of ferrous sulphate twice weekly Twice weekly for 4 weeks and then repeated 4weekly till delivery participants in the intermittent iron group will take 200mg of ferrous sulphate twice per week for 4 weeks. At the end of the 4 weeks period, the tablet pack will be counted and reviewed to check for compliance and the amount taken noted. The regimen will be repeated 4 weekly for the duration of the study for both groups. The participants will be told to take the tablet in the morning when they have empty stomach or at least 30 minutes before meal and not to take it with milk, tea or coffee. In addition, they will be informed to take the iron tablet with Vitamin C for maximum absorption. The will be told to report any side effect like nausea, vomiting, heartburns, diarrhea, constipation etc. The baseline serum haemoglobin, serum ferritin will be measured in all participants at the point of recruitment and repeated twice. The second and third samples will be obtained at 24-28 weeks and 34-36 weeks respectively after commencement of iron supplementation so as to determine the effect of treatment on serum haemoglobin and ferritin respectively. Only samples of participants who take their drugs regularly based on the group she belongs to will be taken and analysed. The participants will be followed up till delivery and the delivery outcomes noted 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting singleton pregnancies presenting to antenatal clinic after 12 weeks of gestation. • Pregnancies below 12 weeks • Multiple gestation. • Pregnancies complicated by haemoglobinopathies, • Established iron deficiencies anaemia • Chronic maternal illness eg Tuberculosis, malignancies. • Maternal smoking. Adult: 19 Year-44 Year 18 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 17/05/2023 NAUTHHREC
Ethics Committee Address
Street address City Postal code Country
Old Onitsha Road Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Mean haemoglobin level in both groups • The change in haemoglobin level after 4 weeks of iron therapy in both groups The baseline serum haemoglobin, serum ferritin will be measured in all participants at the point of recruitment and repeated twice. The second and third samples will be obtained at 24-28 weeks and 34-
Secondary Outcome • Mean Ferritin level • Side effect profile (nausea, vomiting, constipation, diarrhea, heartburn) • Preterm labour • Preterm premature rupture of fetal membranes (PROM) • Maternal adherence level. • Mode of delivery • Neonatal birth weight • APGAR score The baseline serum haemoglobin, serum ferritin will be measured in all participants at the point of recruitment and repeated twice. The second and third samples will be obtained at 24-28 weeks and 34-
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Old Onitsha road Nnewi 435101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The principal investigator DR IBE ANDREW OBIEFUNA will bear the cost of the work Department of Obstetrics and Gynaecology, NAUTH Nnewi 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR IBE ANDREW OBIEFUNA Old Onitsha Road Nnewi 435101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Clara Ajuba Department of haematology, NAUTH Old onitsha road Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ANDREW IBEH drandrewibe@gmail.com +2348037093986 Old Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Specialist senior registrar in Obstetrics and Gynaecology Dept of OBGYN NAUTH
Role Name Email Phone Street address
Public Enquiries George Eleje georgel21@yahoo.com +2348068117444 Old Onitsha road
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Dept of OBGYN NAUTH
Role Name Email Phone Street address
Scientific Enquiries Chigozie Okafor chigolz@yahoo.com +2348034802657 Old Onitsha Road
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynaecologist Dept of OBGYN NAUTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Immediately following publication, No end date Not applicable
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