Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)

This study, called 'IronMother,' is for pregnant women who have anaemia because of low iron levels. We are comparing two ways of taking iron pills: either every day or every other day. The main goal is to see which method helps improve iron levels more effectively within four weeks, and if one causes fewer side effects like an upset stomach. We will also check how easy it is for women to take the pills as prescribed, and look at important health information for both mother and baby, such as delivery outcomes, baby's birth weight, and if the baby needs special care. The study uses a common iron supplement called Galfer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

University College Dublin

Enrolment target

230

Start

17 May 2024

Iron deficiency anaemia in pregnancy

What is this study about?

When you're pregnant, your body needs more iron to make extra blood for you and your baby. Sometimes, even if you eat iron-rich foods, your iron levels can get too low, leading to a condition called iron deficiency anaemia. This can make you feel very tired, weak, and generally unwell. If left untreated, it can sometimes lead to problems for both you and your baby.

This study, called 'Daily versus alternate day oral iron supplementation for the treatment of iron deficiency anaemia in pregnancy (IronMother)', is trying to find the best way to help pregnant women with low iron levels. We already know that iron supplements can help, but we're trying to figure out if taking the iron pills every day or every other day is more effective. We also want to understand which way causes fewer tummy upsets or other side effects, making it easier for women to stick to their treatment.

The main thing we'll be looking at is how much your iron levels (measured by something called haemoglobin or Hb) improve after four weeks of taking the iron. We'll also check other things like your stored iron levels (ferritin), how many pills you've taken, and any discomfort you might feel. Importantly, we'll also be gathering information about your delivery and your baby's health, such as birth weight and whether the baby needs any extra care after birth. This helps us understand the full picture of how different iron treatments might affect both mother and baby.

Key takeaways

Compares daily vs. every-other-day iron for pregnant women with anaemia.
Aims to find the most effective and tolerable iron dosing schedule.
Monitors iron levels, side effects, and overall health of mother and baby.
Uses a common iron supplement called Galfer 305mg.
Study duration involves 4 weeks of treatment plus follow-up for birth outcomes.

Who may be eligible?

This study is looking for women who are pregnant and have been diagnosed with iron deficiency anaemia. You must be at least 18 years old to take part.

There may be other specific health requirements or conditions that mean you can or cannot join the study. This is to make sure the study is safe for everyone involved and that the results are clear and useful.

It's important to talk to your doctor about all of your health conditions and any medications you are taking, even if they seem unrelated, to find out if this study is right for you.

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.

Are you pregnant and at least 18 years old?
Have you been diagnosed with iron deficiency anaemia?
Are you able to attend appointments for blood tests and questionnaires?
Are you willing to take oral iron supplements as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given an iron supplement called Galfer. You will either take this medicine every day or every other day, depending on which group you are in. The study treatment period will last for four weeks.

During these four weeks, you'll have appointments to check your iron levels with blood tests. We will also ask you to fill out questionnaires about how you're feeling, any side effects you might be experiencing, especially tummy troubles, and how easy you find it to take your medicine. We will also check how many pills you have taken. After the main treatment period, we will continue to gather some information about your delivery and your baby's health.

Potential risks and benefits

Taking part in this study may offer you the potential benefit of improving your iron levels and reducing symptoms of anaemia under close medical supervision. However, there's no guarantee that the treatment will work for you, or that one way of taking the treatment will be better than the other. Like all medicines, the iron supplement may have side effects, such as an upset stomach, constipation, or diarrhoea. The study will carefully monitor for these. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Ireland

Common questions

What is iron deficiency anaemia?

It means you have low iron in your blood, which can make you feel tired, dizzy, and weak, especially during pregnancy.

What is Galfer?

Galfer is a common iron supplement that doctors often prescribe to help treat low iron levels.

Will I know if I'm taking the pill every day or every other day?

The study is designed so that neither you nor your doctor will know which schedule you are on during the main treatment period. This helps make the study results as fair as possible.

Are there any extra tests besides blood tests?

Yes, you'll also be asked to fill out questionnaires about how you're feeling and any side effects, and we'll check how many pills you've taken.

How long will I be in the study?

The main treatment part of the study lasts for four weeks, but we will gather information about your delivery and baby's birth after that point.