Condition category
Haematological Disorders
Date applied
01/03/2017
Date assigned
13/03/2017
Last edited
13/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
+234 803 323 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 measures

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

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

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
+234 815 209 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

01/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes