NCT04356326RecruitingPhase 3
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 19 Apr 2020
- Start date
- 15 Feb 2021
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Diseases
- High blood pressure
- NCT number
- NCT04356326
- EudraCT number
- 2018-004160-58
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 15 Feb 2021 to the primary completion date, 28 Feb 2029
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient receiving aspirin for another indication outside pregnancy,
Other illness
- ---Medical history requiring anticoagulation (antiphospholipid syndrome, deep vein thromboembolic disease, pulmonary embolism, atherothrombosis, patient with mechanical heart valves),
- 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),
- Hemostasis disorders, including hemophilia (with thrombocytopenia)
- Any constitutional or acquired hemorrhagic disease, (including digestive hemorrhages, history of hemorrhagic stroke and thrombocytopenia
- Patients with psychiatric follow-up, poor understanding of French or cognitive problems,
- Duodenal ulcer,
- Severe renal impairment,
- Severe hepatic insufficiency,
- Severe cardiac impairment,
Lab values
- Platelet count lower than 100,000 cells/microliter (dosage less than 6 months old),
- Human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus positive serum,
- Patients with known glucose-6-phosphate dehydrogenase deficiency,
Age
- Age \<18 years old,
Other
- Patient with significant proteinuria (\> 300mg/24 hours or a proteinuria/creatininuria ratio ≥ 30mg/mmol),
- Patient included in another interventional study which could interfere with the results of the study,
- Women under the protection of justice,
- Gout,
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.