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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
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

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
CHU Caen
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CaenFranceWithdrawn
CHU Antoine Béclère, AP-HP
Coordinator of this site? Confirm its status
ClamartFranceRecruiting
Hôpital Louis Mourier, AP-HP
Coordinator of this site? Confirm its status
ColombesFranceRecruiting
Centre Hospitalier Intercommunal de Créteil
Coordinator of this site? Confirm its status
CréteilFranceRecruiting
CHU Dijon
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DijonFranceRecruiting
CHU Bicêtre, AP-HP
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Le Kremlin-BicêtreFranceRecruiting
CHRU Lille
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LilleFranceNot yet recruiting
Chu Lyon
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LyonFranceRecruiting
Hôpital St Joseph
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MarseilleFranceWithdrawn
CHRU Nancy
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NancyFranceWithdrawn
CHU Nantes
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NantesFranceRecruiting
Hôpital Trousseau, AP-HP
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ParisFranceRecruiting
CHU Cochin- Port Royal, AP-HP
Coordinator of this site? Confirm its status
ParisFranceRecruiting
CHU Tenon
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ParisFranceRecruiting
CHU Robert Débré, AP-HP
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ParisFranceRecruiting
Ch Poissy
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PoissyFranceRecruiting
Chu St-Etienne
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Saint-EtienneFranceRecruiting
CHU Toulouse
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ToulouseFranceNot yet recruiting
CHU Tours
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ToursFranceWithdrawn

This page is information, not medical advice. Discuss any trial with your doctor.