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CHASAP : Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a multicenter prospective randomized double-blind placebo-controlled trial.
EU CTIS ID: 2024-516461-36-00
What this study is testing
To compare, in pregnant women with chronic hypertension, the efficacy of Aspirin (acetylsalicylic acid) at a dose of 150 mg / day with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pregnant women between 10 weeks and 19 weeks + 6 days
- Chronic hypertension, whether treated or not
- Singleton pregnancy
- Signed the written informed consent
- Affiliation to social security
You likely can't join if
- Medical history requiring anticoagulation (antiphospholipid syndrome, deep vein thromboembolic disease, pulmonary embolism, atherothrombosis, patient with mechanical heart valves),
- Human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus positive serum,
- Patient included in another interventional study which could interfere with the results of the study
- Age <18 years old,
- Geographic inaccessibility (less likely to comply with necessary follow-up visits and Care),
- Women under the protection of justice,
See the full eligibility criteria
- Pregnant women between 10 weeks and 19 weeks + 6 days
- Chronic hypertension, whether treated or not
- Singleton pregnancy
- Signed the written informed consent
- Affiliation to social security
- Medical history requiring anticoagulation (antiphospholipid syndrome, deep vein thromboembolic disease, pulmonary embolism, atherothrombosis, patient with mechanical heart valves),
- Human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus positive serum,
- Patient included in another interventional study which could interfere with the results of the study
- Age <18 years old,
- Geographic inaccessibility (less likely to comply with necessary follow-up visits and Care),
- Women under the protection of justice,
- Patients with psychiatric follow-up, poor understanding of French or cognitive problems.
- Duodenal ulcer,
- Severe renal impairment,
- Severe hepatic insufficiency,
- Severe cardiac impairment
- Patient receiving aspirin for another indication outside pregnancy
- Gout
- Patients with known glucose-6-phosphate dehydrogenase deficiency,
- Patient with significant proteinuria (> 300mg/24 hours or a proteinuria/creatininuria ratio ≥ 30mg/mmol),
- Active bleeding,
- History of severe PE with delivery < 34 weeks of gestation,
- Hypersensitivity to salicylates such as aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Platelet count lower than 100,000 cells/microliter (dosage less than 6 months old),
- Hemostasis disorders, including hemophilia (with thrombocytopenia)
- Any constitutional or acquired hemorrhagic disease, (including digestive haemorrhages, history of haemorrhagic stroke and thrombocytopenia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.