RecruitingOBSERVATIONAL

PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism

This international study, called PREP and GO, is designed to understand the best ways to manage blood-thinning medication (specifically a type called LMWH) for pregnant people. Blood clots, known as VTE, can be a serious concern during pregnancy and after birth. The study will collect information on how these medications are given around the time of labour and delivery, and in the weeks following. Researchers want to learn about any bleeding problems, the risk of blood clots, how women feel about their delivery experience, and the healthcare they receive. This will help doctors make better decisions about using blood thinners to protect mothers from clots while keeping them safe from other risks.

At a glance

Status

Recruiting

Sponsor

University of Calgary

Enrolment target

825

Start

04 Apr 2023

Estimated completion

31 Dec 2029

What is this study about?

The PREP and GO study is looking into how blood-thinning medicines are used for pregnant people who are at risk of developing blood clots. Blood clots, sometimes called VTE, can be very serious, and pregnant people may need medication to prevent them. This study will carefully collect information from hospitals around the world about how these blood thinners, particularly a type called LMWH, are given to patients around the time they give birth and in the few weeks afterwards.

The main goal is to gather high-quality information to understand what works best. The study will look at several important things: whether mothers experience any bleeding problems, their risk of getting blood clots, how they feel about their delivery experience, and the kind of healthcare they receive. By understanding all these aspects, doctors can improve their advice and treatment plans for pregnant people who need blood thinners.

Ultimately, this research helps doctors provide the safest and most effective care for mothers. It helps them balance the need to prevent dangerous blood clots with the risk of other issues, like too much bleeding. This will lead to better health outcomes and a safer experience for pregnant people requiring these important medications.

Key takeaways

This study observes how blood thinners are used in pregnancy and after birth.
It helps improve care for pregnant people at risk of blood clots.
You must already be taking LMWH for a blood clot indication.
No new treatments are given; your care remains the same.
Data is collected from your routine medical records and surveys.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old and currently pregnant. A key requirement is that you are already taking a blood-thinning medicine called LMWH during your pregnancy to prevent or treat a blood clot. This includes if you've had a blood clot in this pregnancy, a previous pregnancy, or at some other time. You could also be eligible if you have a medical condition that makes you more likely to get blood clots, which means you need blood thinners.

However, you won't be able to join if you are taking blood thinners for a reason other than preventing blood clots, such as for a faulty heart valve or certain fertility issues. Also, you cannot be part of the study if you plan to give birth at home or in a birthing centre that isn't connected to a hospital. Finally, you must be willing and able to give your permission to be part of the study.

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 18 years old or older?
Are you currently pregnant and taking a blood-thinning injection called LMWH?
Is your LMWH for preventing or treating blood clots (not for other reasons like heart valve issues)?
Do you plan to give birth in a hospital setting?
Are you able to agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will simply collect information about your care throughout your pregnancy, during your labour and delivery, and in the weeks after your baby is born. This involves documenting details about the blood-thinning medicine you are taking, any health issues you experience, and how your delivery goes. There won't be any extra visits or appointments specifically for the study. You will continue to have your usual check-ups, and the study team will gather information from your existing medical records. They will also ask you to complete some questionnaires about your experiences. The study aims to follow you from when you join until around six weeks after you've given birth.

Potential risks and benefits

A potential benefit of taking part is that your information will help doctors understand more about safe and effective care for pregnant people using blood thinners, which could improve care for future mothers. Since this is an observational study, you will not receive any new or experimental treatments, and your medical care will remain exactly as your doctor has planned for you. Therefore, there are no direct medical risks from participating. Your decision to join or not join will not affect your medical care in any way, and you are free to withdraw from the study at any time without giving a reason.

Locations (14)

Duke University Hospital
Verified postcode
Durham, United States· Recruiting
Foothills Medical Centre
Verified postcode
Calgary, Canada· Recruiting
Royal Alexandra Hospital
Verified postcode
Edmonton, Canada· Recruiting
BC Women's Hospital and Health Centre
Verified postcode
Vancouver, Canada· Recruiting
St. Boniface Hospital
Verified postcode
Winnipeg, Canada· Recruiting
McMaster University Medical Centre
Verified postcode
Hamilton, Canada· Recruiting
The Ottawa Hospital - General Campus
Verified postcode
Ottawa, Canada· Recruiting
Montfort Hospital
Verified postcode
Ottawa, Canada· Recruiting
Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting
CHU Sainte-Justine
Verified postcode
Montreal, Canada· Recruiting
The Sir Mortimer B. Davis Jewish General Hospital
Verified postcode
Montreal, Canada· Recruiting
Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting

Common questions

What kind of blood thinner are they studying?

They are specifically looking at a type of blood-thinning medication called Low Molecular Weight Heparin (LMWH).

Will I have to take new medicine if I join?

No, you will not be given any new or different medicine. The study just observes the care you're already receiving.

Do I need to visit the hospital more often for this study?

No, there are no extra hospital visits. Information will be collected during your standard appointments and from your medical records.

What kind of information will they collect?

They will collect details about your blood thinner use, any complications, your delivery experience, and your healthcare needs.

Can I leave the study once I've joined?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Jill Baxter, BSc

jbaxter@ucalgary.ca 403-220-7103 Official trial record

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