Using aspirin to prevent complications in pregnant women with chronic hypertension
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.
This study is testing whether taking low-dose aspirin during pregnancy can help prevent serious complications for women with chronic high blood pressure and their babies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 20 sites (Bordeaux and 19 other locations) |
| Trial ID | NCT04356326 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of acetylsalicylic acid (aspirin) at a dosage of 150 mg per day, administered before 20 weeks of gestation, in preventing maternal and fetal complications in pregnant women suffering from chronic hypertension. Chronic hypertension can lead to severe complications such as preeclampsia, intrauterine growth restriction, and even perinatal death. The study aims to provide evidence for the use of low-dose aspirin as a preventive measure, addressing a significant gap in treatment options for this high-risk population. Participants will be randomly assigned to receive either aspirin or a placebo to assess the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women between 10 and 19 weeks of gestation with a diagnosis of chronic hypertension.
Not a fit: Patients with medical histories requiring anticoagulation or those with significant proteinuria or active bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of severe complications in pregnant women with chronic hypertension, improving maternal and fetal health outcomes.
How similar studies have performed: Previous studies have suggested potential benefits of low-dose aspirin in similar populations, but this specific approach is being rigorously tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * ---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,
Where this trial is running
Bordeaux and 19 other locations
- CHU Bordeaux — Bordeaux, France (Recruiting)
- CHU Caen — Caen, France (Withdrawn)
- CHU Antoine Béclère, AP-HP — Clamart, France (Recruiting)
- Hôpital Louis Mourier, AP-HP — Colombes, France (Recruiting)
- Centre Hospitalier Intercommunal de Créteil — Créteil, France (Recruiting)
- CHU Dijon — Dijon, France (Recruiting)
- CHU Bicêtre, AP-HP — Le Kremlin-Bicêtre, France (Recruiting)
- CHRU Lille — Lille, France (Not_yet_recruiting)
- CHU Lyon — Lyon, France (Recruiting)
- Hôpital St Joseph — Marseille, France (Withdrawn)
- CHRU Nancy — Nancy, France (Withdrawn)
- CHU Nantes — Nantes, France (Recruiting)
- CHU Cochin- Port Royal, AP-HP — Paris, France (Recruiting)
- CHU Robert Débré, AP-HP — Paris, France (Recruiting)
- CHU Tenon — Paris, France (Recruiting)
- Hôpital Trousseau, AP-HP — Paris, France (Recruiting)
- CH Poissy — Poissy, France (Recruiting)
- CHU St Etienne — Saint-Etienne, France (Recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- CHU Tours — Tours, France (Withdrawn)
Study contacts
- Study coordinator: Edouard LE CARPENTIER
- Email: Edouard.Lecarpentier@chicreteil.fr
- Phone: 01 45 17 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.