Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
This study is investigating if a daily low dose of aspirin (150mg) can help pregnant women with long-term high blood pressure avoid serious complications. These complications can include pre-eclampsia (a dangerous condition involving high blood pressure and organ damage during pregnancy), babies not growing well, or other serious issues for the mother and baby. Researchers want to know if starting aspirin early in pregnancy (before 20 weeks) can make a difference. Currently, there isn't a cure for these problems once they happen, so preventing them is really important. While some health organisations recommend aspirin for chronic high blood pressure in pregnancy, clear proof of its effectiveness in this specific group is still being gathered. This trial hopes to provide that important evidence.
At a glance
What is this study about?
This study is about pregnant women who have long-term high blood pressure, also known as chronic hypertension. About 1 to 5 out of every 100 women have this condition. For those who do, there's a higher chance of developing serious problems during pregnancy. These can include pre-eclampsia (a serious condition with high blood pressure and organ damage), the baby not growing as well as expected, or other severe health issues for both mother and baby. If these problems become severe, sometimes the only option is to deliver the baby early, which can carry its own risks. Because there's no cure once these problems start, finding a way to prevent them is really important for the health of mothers and their babies.
Some health experts in the UK and USA already suggest that women with chronic high blood pressure take a low dose of aspirin during pregnancy to help prevent pre-eclampsia. However, this recommendation is based on studies in other groups of women, and there isn't a lot of specific research showing how well it works for women with long-term high blood pressure. Some research in the past used very low doses of aspirin or started it later in pregnancy, and the results weren't always clear. Because of this, some other health bodies, like those in France, haven't yet made the same recommendation, waiting for more solid information.
This study aims to get clear answers. It will compare a daily dose of 150mg aspirin with a dummy pill (placebo) to see if aspirin, started before 20 weeks of pregnancy, can effectively reduce the risk of these complications for mothers and babies. By doing this, the researchers hope to provide strong evidence to help guide future care for pregnant women with chronic high blood pressure.
Key takeaways
- This study is for pregnant women with long-term high blood pressure.
- It tests if 150mg daily aspirin can prevent serious pregnancy complications.
- Aspirin or a dummy pill will be given, starting before 20 weeks of pregnancy.
- The goal is to improve outcomes for mothers and babies.
- Participation involves regular monitoring throughout pregnancy.
Who may be eligible?
To be considered for this study, you would need to be pregnant for between 10 and 19 weeks and 6 days. You must also have chronic high blood pressure, meaning you had it before pregnancy or it was diagnosed early on. This study is for women carrying one baby and you would need to give your written permission to take part and be part of the UK social security system.
There are certain reasons why you wouldn't be able to join the study. These include if you're already taking blood thinners for another health condition, if you're taking aspirin for something else, or if you have certain existing health problems like major kidney, liver, or heart issues. Other reasons include having a history of severe pre-eclampsia that led to an early delivery (before 34 weeks), bleeding problems, allergies to aspirin, or certain infections like HIV or hepatitis.
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 between 10 and 19 weeks + 6 days?
- Do you have high blood pressure that started before pregnancy or early in pregnancy?
- Are you carrying one baby?
- Do you have a condition that requires blood thinners or an allergy to aspirin?
- Have you ever had severe pre-eclampsia leading to early delivery (before 34 weeks)?
- Do you have serious kidney, liver, or heart problems?
What does participation involve?
If you join this study, you will be randomly assigned to either take a daily low-dose aspirin (150mg) or a dummy pill (placebo) until your baby is born. You won't know which one you are taking. You'll have regular check-ups and assessments, just like you would during a standard pregnancy. The study team will monitor your health and your baby's growth very closely. All participants will receive the usual antenatal care. The study will follow you through your pregnancy and delivery to see how you and your baby are doing. The total duration of your participation would be for the remainder of your pregnancy.
Potential risks and benefits
Locations (20)
- CHU BordeauxVerified postcodeBordeaux, France· Recruiting
- CHU CaenVerified postcodeCaen, France· Withdrawn
- CHU Antoine Béclère, AP-HPVerified postcodeClamart, France· Recruiting
- Hôpital Louis Mourier, AP-HPVerified postcodeColombes, France· Recruiting
- Centre Hospitalier Intercommunal de CréteilVerified postcodeCréteil, France· Recruiting
- CHU DijonVerified postcodeDijon, France· Recruiting
- CHU Bicêtre, AP-HPVerified postcodeLe Kremlin-Bicêtre, France· Recruiting
- CHRU LilleVerified postcodeLille, France· Not yet recruiting
- CHU LyonVerified postcodeLyon, France· Recruiting
- Hôpital St JosephVerified postcodeMarseille, France· Withdrawn
- CHRU NancyVerified postcodeNancy, France· Withdrawn
- CHU NantesVerified postcodeNantes, France· Recruiting
Common questions
What is chronic hypertension?
Chronic hypertension means you have high blood pressure that started before your pregnancy or was diagnosed early on, usually before 20 weeks.
What is pre-eclampsia?
Pre-eclampsia is a serious pregnancy condition where you develop high blood pressure and signs that some of your organs, like your kidneys or liver, are not working properly. It can be dangerous for both mother and baby.
Why 150mg of aspirin?
Past studies haven't always shown clear results with very low doses of aspirin. This study is testing a slightly higher dose (150mg) to see if it's more effective in preventing complications.
What is a 'dummy pill' (placebo)?
A dummy pill looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the study drug against no treatment, so they can be sure any effects are due to the aspirin and not just other factors.
Who is funding this research?
The information provided doesn't specify the funding source. This is usually detailed in the full study protocol or on the clinical trials registry.
How to find out more
Edouard LE CARPENTIER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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