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RecruitingPHASE4INTERVENTIONAL

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

This study aims to find out if a blood-thinning medication, called Low Molecular Weight Heparin (LMWH), can safely and effectively prevent serious blood clots in women after they've had a baby. Blood clots are a major health concern for new mothers, especially in the first few weeks after birth. Many women have a medium risk of developing these clots due to factors like obesity or having a C-section. Currently, there isn't clear advice on whether blood thinners help for this group of women. This research will compare new mothers who take LMWH for 6 weeks after delivery with those who don't, to see if the medication reduces the chance of clots and if it's safe to use.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
University Hospital, Brest
Enrolment target
2,400
Start
16 May 2025
Estimated completion
16 Aug 2028

What is this study about?

Blood clots that form in the veins, known as Venous Thromboembolism (VTE), can be very serious. They are a big worry for women, especially after giving birth, and can sometimes be life-threatening. About half of these clots in new mothers happen in the weeks following delivery. While we know that some women are at a higher risk of getting these clots, there's no clear guidance for those who have a 'medium risk'. This group often includes mothers who have had a C-section, are overweight, or have experienced a lot of bleeding after birth.

Because there isn't a lot of research specifically for new mothers with an average risk of clots, doctors currently use guidelines based on studies of other groups of people, or smaller observations. This means the advice can differ from country to country. This study wants to change that by directly comparing two approaches for new mothers with this medium risk.

We want to see if giving a blood-thinning medicine called Low Molecular Weight Heparin (LMWH) for six weeks after delivery is better at preventing blood clots than not giving any blood thinners. The study will allow doctors and patients to choose the specific type of LMWH. We hope this research will provide clearer, evidence-based advice to help protect new mothers from dangerous blood clots in the future.

Key takeaways

  • This study looks at preventing blood clots in new mums.
  • It tests a blood-thinning medicine called LMWH for 6 weeks after birth.
  • It's for women with a 'medium risk' of blood clots, not high or low.
  • The goal is to find better ways to keep new mothers safe.
  • You might get LMWH or usual care; it will be decided randomly.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for women who have recently given birth and are considered to have a 'medium risk' of developing a blood clot. This risk is usually 3% or higher, based on a special calculation model that looks at things like if you smoke, if you're overweight, if you have certain health conditions like diabetes or pre-eclampsia, or if you had a C-section or heavy bleeding after birth. You must be over 18 years old and have given birth between 6 and 36 hours before joining the study. You also need to be able to fully understand and agree to take part.

However, there are reasons why some women cannot join. These include if you've ever had a deep vein blood clot before, if you're already taking blood thinners for your pregnancy, or if you need blood-thinning medicine for a current condition. You also can't take part if you have a medical reason that makes LMWH unsafe for you, such as certain blood problems or severe kidney issues. If you've already received more than two doses of LMWH since delivery, or if you're taking aspirin daily (100mg) or other specific anti-clotting medicines, you won't be able to join. Lastly, if you've been part of a similar study before or are currently in another study testing a treatment, you won't be eligible.

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.

  1. Are you over 18 years old?
  2. Did you give birth between 6 and 36 hours ago?
  3. Have you been told you have a 'medium risk' of blood clots after delivery?
  4. Have you never had a blood clot before, or already been on LMWH during pregnancy?
  5. Do you have any conditions that would make blood thinners unsafe for you?
Answer every question to see your result.

What does participation involve?

If you join this study, you would either receive a blood-thinning injection (LMWH) once a day for six weeks after your baby is born, or you would not receive any blood-thinning medication. The specific type of LMWH would be decided by you and your doctor. You would have regular check-ups, similar to the care you would usually receive after giving birth, particularly when you go for your standard 6-week post-delivery check-up to see how you are recovering. The study will mainly involve monitoring your health during this 6-week period after delivery.

Potential risks and benefits

Taking part in this study could potentially help us understand the best way to prevent dangerous blood clots in new mothers, which might benefit future women. For you personally, if you are in the group receiving LMWH, it might reduce your risk of developing a clot. However, all medicines have possible side effects, and LMWH can increase the risk of bleeding. If you are in the group that doesn't receive LMWH, you might not be protected from clots, but you also wouldn't have the bleeding risk from the medication. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • CHU d'Amiens Picardie
    Verified postcode
    Amiens, France· Not yet recruiting
  • CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • CHU de Brest
    Verified postcode
    Brest, France· Recruiting
  • Hôpital Béclère, AP-HP
    Verified postcode
    Clamart, France· Not yet recruiting
  • CHU de Clermont Ferrand Site Estaing
    Verified postcode
    Clermont-Ferrand, France· Not yet recruiting
  • CH départemental de Vendée
    Verified postcode
    La Roche-sur-Yon, France· Not yet recruiting
  • Hôpital Bicêtre, AP-HP
    Verified postcode
    Le Kremlin-Bicêtre, France· Not yet recruiting
  • Hôpital Nord Marseille, AP-HM
    Verified postcode
    Marseille, France· Not yet recruiting
  • Centre Hospitalier des Pays de Morlaix
    Verified postcode
    Morlaix, France· Not yet recruiting
  • CHRU de Nancy
    Verified postcode
    Nancy, France· Not yet recruiting
  • CHU de Nantes
    Verified postcode
    Nantes, France· Not yet recruiting
  • Hôpital Lariboisière, AP-HP
    Verified postcode
    Paris, France· Not yet recruiting

Common questions

What is LMWH?

LMWH stands for Low Molecular Weight Heparin. It's a type of medicine given by injection that helps to thin your blood and stop clots from forming.

What does 'intermediate risk' mean?

It means you have a medium chance of getting a blood clot after having your baby, based on things like your medical history or details of your delivery, but not a very high or very low chance.

Will I have to do anything extra if I join the study?

The main difference is you might need to take daily injections of LMWH for 6 weeks. Any follow-up visits would mostly align with your usual care after childbirth.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any time, for any reason, and it won't affect the care you receive from your doctors.

Is this medicine safe for breastfeeding mothers?

The safety of LMWH during breastfeeding would be discussed by your doctor, as part of your decision to join the study.

How to find out more

Emmanuelle LE MOIGNE, MD, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Prevention of Postpartum Venous Thromboembolism in Women at …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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