Assessing the effect of different doses of iron supplementation in pregnant women
| ISRCTN | ISRCTN77724888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77724888 |
| Secondary identifying numbers | ERC/2015/09/05 |
- Submission date
- 01/03/2017
- Registration date
- 13/03/2017
- Last edited
- 08/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Scientific
Obstetrics and Gynaecology Department
Lautech Teaching Hospital
Osogbo
360104
Nigeria
| Phone | +234 (0)803 323 8808 |
|---|---|
| sek_aiy@yahoo.com |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Serum ferritin level in non-anaemic pregnant women on daily versus weekly iron supplement: A randomized control trial |
| Study objectives | 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(s) | Obafemi Awolowo University Teaching Hospital Ethics and Research Committee, 22/09/2015, ref: IRB/IEC/0004553 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 22/05/2015 |
| Completion date | 22/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 250 women |
| Total final enrolment | 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/09/2015 |
| Date of final enrolment | 30/01/2017 |
Locations
Countries of recruitment
- Nigeria
Study participating centres
220005
Nigeria
360104
Nigeria
Sponsor information
Hospital/treatment centre
-
Ile-Ife
220005
Nigeria
| Phone | +234 (0)815 209 2751 |
|---|---|
| oauthcethicalcommittee@yahoo.com | |
"ROR" |
https://ror.org/05bkbs460 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at RCOG World Congress | 01/06/2019 | 08/04/2020 | No | No |
Editorial Notes
08/04/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
20/07/2018: The intention to publish date was changed from 01/01/2018 to 01/01/2019.
