Plain English Summary
Background and study aims
Anaemia is a condition in which there are not enough red blood cells or not enough of the component of blood that binds to oxygen (haemoglobin). Haemoglobin is made from iron and so a deficiency in iron can lead to a type of anaemia called iron-deficiency anaemia. Iron-deficiency anaemia during pregnancy is a common condition, particularly in developing countries where people often do not get adequate iron from their diets. Iron supplements are usually used to treat this condition, however they can have unpleasant side-effects such as nausea and constipation and so many women are reluctant to take them. To prevent the development of iron-deficiency anaemia during pregnancy, the World Health Organisation (WHO) recommends that pregnant women in developing countries should receive 60mg of iron every day from when they are 18 weeks pregannt. The aim of this study is to compare the effectiveness of once weekly supplementation of oral iron therapy against the current practice of daily supplementation in order to prevent iron-deficiency anaemia during pregnancy.
Who can participate?
Women who are 18 weeks pregnant who are not anaemic.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are asked to take one iron tablet every day until they have their baby. Those in the second group take three iron tablets once each week until they have their baby. At the start of the study when women are 18 weeks pregnant and again when women are 37 weeks pregnant, women in both groups have blood samples taken to measure their iron levels. In addition, their baby’s weight when born is also recorded.
What are the possible benefits and risks of participating?
There are no direct benefits to participants however taking part in this study will help increase knowledge about how best to give iron supplements to prevent iron-deficiency anaemia in pregnancy. There is a small risk that some participants may experience discomfort or bruising from blood tests.
Where is the study run from?
1. Obafemi Awolowo University Teaching Hospitals Complex (Nigeria)
2. Ladoke Akintola University of Technology Teaching Hospital (Nigeria)
When is the study starting and how long is it expected to run for?
May 2015 to May 2017
Who is funding the study?
Obafemi Awolowo University Teaching Hospitals Complex (Nigeria)
Who is the main contact?
Dr Sekinah Bola-Oyebamiji
sek_aiy@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sekinah Bola-Oyebamiji
ORCID ID
Contact details
Obstetrics and Gynaecology Department
Lautech Teaching Hospital
Osogbo
360104
Nigeria
+234 (0)803 323 8808
sek_aiy@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ERC/2015/09/05
Study information
Scientific title
Serum ferritin level in non-anaemic pregnant women on daily versus weekly iron supplement: A randomized control trial
Acronym
Study hypothesis
Weekly supplementation of 195mg of elemental iron is as effective as daily supplementation with 65mg elemental iron in maintaining normal serum ferritin level in pregnancy.
Ethics approval
Obafemi Awolowo University Teaching Hospital Ethics and Research Committee, 22/09/2015, ref: IRB/IEC/0004553
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Iron deficiency anaemia in pregnancy
Intervention
Participants are randomised to one of two groups by allocating odd and even numbers to the participants at their antenatal booking clinic. Participantss with even number will be drafted to the daily group while those with even numbers will be allocated to the weekly group.
Arm 1 (daily group): Participants will receive one tablet of ferrous sulphate (Fesulf by Therapeutic pharmaceuticals, Lagos) 200mg BP equivalent to 65mg elemental iron once daily from 20 weeks of gestation until delivery.
Arm 2 (weekly group): Participants will receive three tablets of ferrous sulphate (Fesulf 200mg BP by Therapeutic pharmaceuticals, Lagos) at once on a particular day of the week from 18 weeks until delivery.
Blood samples for heamoglobin concentration and serum ferritin will be drawn from all participants in both arms at baseline (20 weeks gestation), and 37 weeks gestation.
Intervention type
Drug
Phase
Not Applicable
Drug names
Ferrous sulphate
Primary outcome measure
1. Serum ferritin level is measured using a fasting 5mls blood sample collected in a plain universal using Accu-Bind ELISA Microwells Ferritin Test System at baseline (20 weeks gestation), and 37 weeks gestation
2. Heamoglobin concentration will be measured using a capillary tube blood sample drawn at baseline (20 weeks gestation), and 37 weeks gestation
Secondary outcome measures
Baby's birthweight is measured using Seca 354 electronic baby weighing (Seca Cirencester UK) scale after delivery.
Overall trial start date
22/05/2015
Overall trial end date
22/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant women at an estimated gestation age of 18 weeks
2. Not anaemic
3. Haemoglobin genotype of AA or AS
4. Provision of informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
250 women
Total final enrolment
250
Participant exclusion criteria
1. Exceeded the 20th week of pregnancy
2. Haemoglobin genotype SS or SC
3. Anaemic pregnant women with haemoglobin less than 100g/L
4. Those who are not willing to participate in the study
Recruitment start date
30/09/2015
Recruitment end date
30/01/2017
Locations
Countries of recruitment
Nigeria
Trial participating centre
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife
220005
Nigeria
Trial participating centre
Ladoke Akintola University of Technology Teaching Hospital
Osogbo
360104
Nigeria
Sponsor information
Organisation
Obafemi Awolowo University Teaching Hospitals Complex
Sponsor details
-
Ile-Ife
220005
Nigeria
+234 (0)815 209 2751
oauthcethicalcommittee@yahoo.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Obafemi Awolowo University Teaching Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
01/01/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results presented at RCOG World Congress in https://doi.org/10.1111/1471-0528.12_15703 (abstract 668) (added 08/04/2020)