Status:
RECRUITING
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Conditions:
Chronic Hypertension Complicating Pregnancy
Pre-Eclampsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Chronic hypertension affects 1 to 5% of women of childbearing age. According to the literature, about 45% of pregnant women with chronic hypertension will develop complications such as superimposed pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- ---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 interventional 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,
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04356326
Start Date
February 15 2021
End Date
February 1 2030
Last Update
September 2 2025
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Bordeaux
Bordeaux, France
2
CHU Caen
Caen, France, 14000
3
CHU Antoine Béclère, AP-HP
Clamart, France
4
Hôpital Louis Mourier, AP-HP
Colombes, France