Study of Acetylsalicylic Acid (Aspirin) 150 mg for Prevention of Complications in Pregnant Women with Chronic Hypertension

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What is this study about?

This study focuses on pregnant women with chronic hypertension, a condition where blood pressure remains consistently high. The research examines how acetylsalicylic acid (also known as aspirin) affects pregnancy-related complications including pre-eclampsia (a serious condition causing high blood pressure during pregnancy), fetal growth restriction (when a baby doesn’t grow properly in the womb), and other pregnancy-related blood pressure problems.

The study compares the effects of taking 150 mg of acetylsalicylic acid daily with a placebo to prevent serious complications that could affect both mother and baby. These complications include pre-eclampsia, separation of the placenta from the womb, reduced baby growth, early delivery, and other serious health issues for both mother and baby.

Participants in this study will receive either acetylsalicylic acid in the form of gastro-resistant tablets (tablets that dissolve in the intestine rather than the stomach) or identical-looking placebo tablets. The treatment continues for 6 months during pregnancy. The study is designed so that neither the pregnant women nor their healthcare providers know which treatment they are receiving during the study period.

1 Initial participation phase

You will begin participation between 10 weeks and 19 weeks + 6 days of pregnancy

Your pregnancy must be confirmed as a single baby pregnancy (not twins or multiple)

You must have chronic high blood pressure (treated or untreated)

2 Medication administration

You will receive either acetylsalicylic acid (150 mg tablets) or a placebo tablet

The medication is to be taken daily by mouth

The tablets are specially coated to protect your stomach (gastro-resistant)

You will need to maintain a diary to record your medication intake

3 Monitoring during pregnancy

Your pregnancy will be monitored for various conditions including:

– High blood pressure complications in pregnancy

– Baby’s growth progress

– Any signs of the placenta separating from the uterus

Blood and urine samples will be collected to measure specific proteins related to pregnancy

4 Birth and immediate follow-up

Your delivery will be monitored and documented

Information about your baby’s birth weight and overall health will be recorded

Any complications during delivery will be documented

5 Long-term follow-up

Your child’s development will be monitored at age 2 and 4 years

The study will continue until November 2026

Who Can Join the Study?

  • Must be a pregnant woman between 10 weeks and 19 weeks plus 6 days of pregnancy
  • Must have chronic high blood pressure (whether currently being treated or not)
  • Must be carrying only one baby (singleton pregnancy)
  • Must be willing and able to provide written informed consent to participate in the study
  • Must have active social security coverage

Who Cannot Join the Study?

  • Known allergy or hypersensitivity to aspirin or other similar medications
  • Multiple pregnancy (carrying more than one baby)
  • History of bleeding disorders or significant bleeding problems
  • Active peptic ulcer disease (stomach or intestinal ulcers)
  • Current use of blood-thinning medications (such as warfarin)
  • Liver disease with abnormal blood clotting
  • History of severe kidney disease
  • Previous adverse reaction to aspirin therapy
  • Participation in another clinical trial within the past 30 days
  • Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study
  • Inability to provide informed consent
  • Planned delivery at a non-participating hospital
  • Current regular use of aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
  • Platelet count less than 100,000 per microliter of blood (a condition affecting blood clotting)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Hopital Antoine Beclere Clamart France
Robert Debre University Hospital Paris France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Cwrqyl Hayrpnqzqbv Iafsjoxa Giuxassj Montreuil France
Alackvrrhn Puxlrpgi Husnfakw De Pbhkz Paris France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.02.2021

Trial locations

Investigated drugs:

Aspirin (acetylsalicylic acid) is a medication commonly used to reduce pain, fever, and inflammation. In this trial, it is being studied for its potential benefits in pregnant women with chronic high blood pressure. The medication works by preventing the formation of certain substances in the body that cause inflammation and blood clotting. When used during pregnancy, it may help prevent serious complications by improving blood flow to the placenta and reducing the risk of blood clots.

Investigated diseases:

Chronic Hypertension in Pregnancy – A condition where high blood pressure exists before pregnancy or develops before 20 weeks of gestation. The elevated blood pressure continues throughout pregnancy, putting additional stress on the cardiovascular system.

Pre-eclampsia – A pregnancy complication characterized by high blood pressure and signs of damage to organ systems, typically occurring after 20 weeks of pregnancy. It involves reduced blood flow to the placenta and can cause swelling, protein in urine, and other symptoms.

Fetal Growth Restriction – A condition where an unborn baby is smaller than expected for its gestational age due to not growing at a normal rate inside the womb. The baby’s estimated weight is below what’s expected for its gestational age, often falling below the 10th percentile.

Placental Abruption – A serious condition that occurs when the placenta partially or completely separates from the inner wall of the uterus before delivery. This separation can reduce or block the baby’s supply of oxygen and nutrients.

Preterm Delivery – The birth of a baby before 37 weeks of pregnancy have been completed. The earlier the delivery occurs in pregnancy, the more challenging it can be for the baby.

Trial ID:
2024-516461-36-00
Protocol code:
CHASAP
NCT ID:
NCT04356326
Trial Phase:
Therapeutic confirmatory (Phase III)

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