Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT04356326

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-09-02

500

Participants Needed

20

Research Sites

467 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women between 10 and 19 weeks plus 6 days of gestation
  • Chronic hypertension diagnosed before pregnancy or before randomization, treated or untreated
  • Singleton pregnancy
  • Signed written informed consent
  • Affiliated to social security
Not Eligible

You will not qualify if you...

  • Medical history requiring anticoagulation (e.g., antiphospholipid syndrome, deep vein thrombosis, pulmonary embolism, atherothrombosis, mechanical heart valves)
  • Currently taking aspirin for reasons other than pregnancy
  • Significant proteinuria (>300 mg/24 hours or proteinuria/creatininuria ratio ≥ 30 mg/mmol)
  • Active bleeding
  • History of severe preeclampsia with delivery before 34 weeks gestation
  • Allergic to salicylates such as aspirin or NSAIDs
  • Platelet count below 100,000 cells/microliter (within last 6 months)
  • Bleeding disorders including hemophilia
  • Any inherited or acquired hemorrhagic disease (including digestive hemorrhages, history of hemorrhagic stroke, thrombocytopenia)
  • Positive for HIV, hepatitis B, or hepatitis C
  • Participating in another interventional study affecting results
  • Under 18 years old
  • Under legal protection
  • Psychiatric follow-up, poor understanding of French, or cognitive issues
  • Duodenal ulcer
  • Severe kidney failure
  • Severe liver failure
  • Severe heart failure
  • Gout
  • Known glucose-6-phosphate dehydrogenase deficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

CHU Bordeaux

Bordeaux, France

Actively Recruiting

2

CHU Caen

Caen, France, 14000

Withdrawn

3

CHU Antoine Béclère, AP-HP

Clamart, France

Actively Recruiting

4

Hôpital Louis Mourier, AP-HP

Colombes, France

Actively Recruiting

5

Centre Hospitalier Intercommunal de Créteil

Créteil, France, 94000

Actively Recruiting

6

CHU Dijon

Dijon, France

Actively Recruiting

7

CHU Bicêtre, AP-HP

Le Kremlin-Bicêtre, France

Actively Recruiting

8

CHRU Lille

Lille, France

Not Yet Recruiting

9

CHU Lyon

Lyon, France

Actively Recruiting

10

Hôpital St Joseph

Marseille, France

Withdrawn

11

CHRU Nancy

Nancy, France

Withdrawn

12

CHU Nantes

Nantes, France

Actively Recruiting

13

CHU Cochin- Port Royal, AP-HP

Paris, France

Actively Recruiting

14

CHU Robert Débré, AP-HP

Paris, France

Actively Recruiting

15

CHU Tenon

Paris, France

Actively Recruiting

16

Hôpital Trousseau, AP-HP

Paris, France

Actively Recruiting

17

CH Poissy

Poissy, France

Actively Recruiting

18

CHU St Etienne

Saint-Etienne, France

Actively Recruiting

19

CHU Toulouse

Toulouse, France

Not Yet Recruiting

20

CHU Tours

Tours, France

Withdrawn

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Research Team

E

Edouard LE CARPENTIER

CONTACT

C

Camille JUNG

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy | DecenTrialz