CompletedPhase IIIInterventional

Prevention of anaemia with oral iron supplementation

During pregnancy, your body needs extra iron to help your baby grow. Many women develop low iron levels (anaemia), which can cause extreme tiredness and other health problems. Right now, the NHS does not routinely offer iron tablets to all pregnant women unless a blood test shows their iron is low. This study, run by NHS Blood and Transplant, is testing whether starting a daily low-dose iron tablet early in pregnancy prevents anaemia and improves health for both mother and baby. Women who take part are randomly chosen to take either an iron tablet or a dummy tablet (placebo) once a day until six weeks after giving birth. The trial lasts around 34 weeks. Taking part is voluntary, and the results could help shape future NHS guidance for antenatal care.

At a glance

Status

Completed

Phase

Phase III

Sponsor

NHS Blood and Transplant

Enrolment target

11,020

Start

01 Mar 2024

Estimated completion

01 Aug 2025

Iron deficiency anaemia in pregnancy

What is this study about?

Iron is an essential mineral that helps your blood carry oxygen around your body. When you are pregnant, your body produces much more blood to support your growing baby and placenta. Because of this, it is very common for iron levels to fall. If they drop too low, you can develop anaemia, leaving you feeling exhausted, weak, dizzy, or short of breath.

At present, the NHS does not give iron tablets to every pregnant woman as a routine measure. Instead, doctors and midwives only prescribe iron if routine blood tests show that you are already anaemic. However, because so many women develop low iron later in pregnancy, researchers want to know if preventing the problem early on is a better approach.

This study aims to discover whether taking a low-dose iron tablet every day, starting from your first booking appointment, improves health outcomes for mothers and their babies. By comparing women who take iron with women who take a dummy tablet, the research team can find out if early iron supplementation should become a standard part of pregnancy care across the UK.

Key takeaways

Tests whether routine low-dose iron tablets from early pregnancy prevent anaemia.
Compares a daily iron tablet against an inactive dummy pill (placebo).
Open to healthy pregnant women aged 18 and over who are not currently anaemic.
Participation lasts from early pregnancy until six weeks after birth (around 34 weeks).
Study appointments are arranged to fit alongside your normal NHS antenatal care.
Taking part is voluntary, and you can leave the study at any time.

Who may be eligible?

This trial is for healthy pregnant women aged 18 and older who are in the early stages of pregnancy (up to 15 weeks and 6 days). To take part, your first routine blood tests must show that you do not already have anaemia, and your early ultrasound scan must show a single, healthy pregnancy.

You cannot take part if you are already anaemic, expecting twins or triplets, or have a known allergy to iron supplements. Women who have conditions where the body absorbs too much iron (such as haemochromatosis), severe bowel conditions, or who have received a blood transfusion in the past 30 days are also unable to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I am currently pregnant with a single baby (not twins or triplets).
I am at or under 15 weeks and 6 days of pregnancy.
My early pregnancy scan confirmed a healthy, growing baby.
My booking blood tests show my iron levels are currently normal.
I do not have a severe bowel condition or an allergy to iron tablets.

Answer every question to see your result.

What does participation involve?

If you agree to take part, a computer will randomly place you into one of two groups. One group will take a low-dose iron tablet once a day, and the other group will take a matching dummy tablet (placebo). Neither you nor your care team will know which tablet you are taking. You will start taking the tablets around week 12 of pregnancy and continue until about six weeks after your baby is born, which is roughly 34 weeks in total. Study checks are designed to fit around your standard NHS antenatal visits, where staff will check your blood counts and monitor your wellbeing. You will also receive simple advice on how to take the tablet to avoid stomach irritation.

Potential risks and benefits

If you receive the iron tablet, it may lower your chances of developing anaemia during your pregnancy, although this cannot be guaranteed. Everyone taking part helps doctors understand how best to care for pregnant women in the future. Like all medicines, iron tablets can cause mild side effects, such as tummy ache, sickness, constipation, loose stools, dark poo, or mouth ulcers. The research team will give you guidance on how to reduce these effects. Taking part is completely your choice, and you can stop at any time without it affecting the care you and your baby receive.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Not provided at time of registration
City only
-, England

Common questions

What is a placebo?

A placebo is a dummy pill that looks and tastes identical to the real medicine but contains no active ingredients. It helps researchers fairly compare whether the real iron tablet makes a genuine difference.

What happens if my blood tests show I become anaemic during the trial?

Your midwife and doctors will monitor your blood regularly as part of your normal care. If you develop anaemia at any point, you will be given appropriate NHS treatment to protect your health.

Can I still take my normal pregnancy vitamins?

Usually yes, but you should discuss all vitamins and supplements with the study team to make sure you are not taking extra iron that could affect the trial.

Will taking an iron tablet harm my baby?

No. Low-dose iron tablets are widely and safely used during pregnancy to treat and prevent low iron levels.

Do I have to pay for the tablets or appointments?

No, all study tablets and trial-related checks are completely free of charge.

How to find out more

Catherine Bain

Catherine.bain@nhsbt.nhs.uk +44 (0)1223 588182 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.