RecruitingInterventional

Preventing miscarriage through platform testing of multiple novel interventions

This study, called PREMIS, is exploring if a common supplement called DHA (a type of omega-3 fatty acid) can help women who have experienced two or more miscarriages. Miscarriage and early births can sometimes be linked to inflammation in the body. DHA might help with this. The researchers are testing two different doses of DHA to see if they can increase the chance of a healthy live birth after 34 weeks of pregnancy. They also want to see if DHA increases the chance of the pregnancy continuing past 11-14 weeks. If you're over 16, actively trying to get pregnant, have had two or more miscarriages, and get a positive pregnancy test, you might be able to take part.

At a glance

Status

Recruiting

Sponsor

University of Birmingham

Enrolment target

1,943

Start

01 Jun 2026

Estimated completion

31 Jan 2030

Medical condition: Miscarriage Medical condition in lay language: Miscarriage Therapeutic areas: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

What is this study about?

This study, called PREMIS, is looking into ways to help women who have gone through the heartache of two or more miscarriages. Miscarriages and babies born too early can sometimes be linked to problems like inflammation or stress in the body. Omega-3 fatty acids, like DHA, are known to be important for a healthy pregnancy and might help calm this inflammation. Currently, there's no NHS treatment specifically to boost DHA levels to try and prevent miscarriage, and we don't fully understand if low DHA levels contribute to miscarriages.

The main goal of this study is to find out if taking DHA supplements can increase the chance of a live birth after 34 weeks for women who have had repeated miscarriages. They are also looking at whether DHA can help pregnancies continue past the crucial 11-14 week mark. Researchers hope that by providing different doses of DHA, they can discover a safe and effective way to support these pregnancies.

This study is important because it could lead to new ways to help women have successful pregnancies. It builds on what we know about how DHA supports pregnancy and addresses a really difficult issue for many families.

Key takeaways

This study aims to prevent miscarriage in women who have had two or more miscarriages.
It tests if DHA (an omega-3 supplement) can increase the chance of a live birth after 34 weeks.
Participants will be randomly assigned to receive either no DHA, a low dose, or a high dose.
The supplements are taken as capsules daily until 24 weeks of pregnancy.
There are no known risks to taking these DHA supplements.
Tommy's Charity is funding this important research.

Who may be eligible?

The study is looking for women who are 16 years old or older and have unfortunately experienced two or more miscarriages in the past. To join, you need to be actively trying to get pregnant and have recently received a positive pregnancy test result.

There are also a couple of things that might mean you can't join. If you already take omega-3 supplements that contain more than 300mg of DHA and aren't able or willing to stop them for the study, you wouldn't be able to participate. Also, if you have allergies or are sensitive to fish or seafood, the supplements might not be suitable 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 a woman aged 16 or over?
Have you experienced two or more miscarriages?
Are you currently trying to get pregnant and have a positive pregnancy test?
Do you eat two or fewer portions of fish per week?
Are you not currently taking other high-dose omega-3 supplements, or are you willing to stop them?
Are you not allergic or sensitive to fish/seafood?

Answer every question to see your result.

What does participation involve?

If you join this study, a computer will randomly place you into one of three groups. You will have a 1 in 3 chance of being in each group. One group will not receive any DHA supplements (this is the 'control' group), another group will receive a low dose of 750mg of DHA each day, and the third group will receive a higher dose of 1125mg of DHA each day.

If you're in one of the DHA groups, you'll take your capsules by mouth every day. The low dose means taking two capsules daily, and the high dose means taking three capsules daily. You would continue taking these until you are 24 weeks pregnant. The study is planned to run from June 2026 until May 2030.

Potential risks and benefits

If you take part in the study, you might benefit from receiving free omega-3 supplements, which could potentially help your pregnancy, although this is what the study aims to find out. There are no known serious risks associated with taking DHA (omega-3) supplements at the doses used in this study. However, if you have any concerns or questions during the study, you can always discuss them with your local care team. Remember, you can choose to leave the study at any time.

Locations (19)

Aberdeen Royal Infirmary
Approximate
Aberdeen, Scotland
Leicester Royal Infirmary
Approximate
Leicester, England
Arrow Park Hospital
City only
Wirral, England
Birmingham Women's Hospital
Approximate
Birmingham, England
University Hospital Coventry
Approximate
Coventry, England
St Peters Hospital
Approximate
Chertsey, England
Burnley General Hospital
Approximate
Burnley, England
Ipswich Hospital
Approximate
Ipswich, England
Worthing Hospital
Approximate
Worthing, England
Princess Royal Hospital
Approximate
Haywards Heath, England
Royal Sussex County Hospital
Unverified
Brighton, England
St Richards Hospital
Unverified
Chichester, England

Common questions

What is DHA?

DHA is a type of healthy fat, an omega-3 fatty acid, found in foods like oily fish. It's known to be important for health, especially during pregnancy.

Why are two different doses being tested?

Researchers want to see if one dose is more effective than another, or if both doses have a similar effect, since there isn't clear guidance yet on the best amount to take.

Who is paying for this study?

The study is being funded by Tommy's Charity, a UK-based charity dedicated to making pregnancy safer.

Where is the study happening?

The study is being organised from the University of Birmingham in the UK.

Can I eat fish if I join the study?

Yes, you can eat fish. The study is designed for people who eat up to two portions of fish per week.

How to find out more

Lee Priest

l.priest.1@bham.ac.uk - Official trial record

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