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New treatment option for Chronic Hypertension Complicating Pregnancy
Official title Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
ClinicalTrials.gov ID: NCT04356326
What this study is testing
What is Aspirin 150 mg?
Aspirin 150 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic hypertension complicating pregnancy.
Also referred to as Active arm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A randomized clinical trial to assess the efficiency of acetylsalicylic acid (aspirin) 150 mg/day started before 20 weeks of gestation in the prevention on maternal and fœtal complications in pregnant women with chronic hypertension.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant patient between 10 and 19 weeks of gestation + 6 days
- Chronic hypertension, whether treated or not, know before pregnancy or diagnosed before randomization
- 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 receiving aspirin for another indication outside pregnancy,
- 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),
See the full eligibility criteria
- Pregnant patient between 10 and 19 weeks of gestation + 6 days
- Chronic hypertension, whether treated or not, know before pregnancy or diagnosed before randomization
- 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),
- Patient receiving aspirin for another indication outside pregnancy,
- 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 hemorrhages, history of hemorrhagic stroke and thrombocytopenia
- Human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus positive serum,
- Patient included in another treatment study which could interfere with the results of the study,
- Age \<18 years old,
- 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,
- Gout,
- Patients with known glucose-6-phosphate dehydrogenase deficiency,
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Caen, France
- Clamart, France
- Colombes, France
- Créteil, France
- Dijon, France
- Le Kremlin-Bicêtre, France
- Lille, France
- Lyon, France
- Marseille, France
- Nancy, France
- Nantes, France
- Paris, France
- Poissy, France
- Saint-Etienne, France
- Toulouse, France
- Tours, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Caen, France; Clamart, France; Colombes, France; Créteil, France; Dijon, France and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.