Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy

NCT04356326 | Recruiting Phase 3

• 2 other identifiers: CHASAP2018-004160-58
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 20

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 women with chronic hypertension.

Conditions

Chronic Hypertension Complicating Pregnancy; Pre-Eclampsia; Intrauterine Growth Restriction; Aspirin; Perinatal Death; Placental Abruption

Outcome Measures

Primary Outcomes (1)

• Composite morbidity-mortality criterion including preeclampsia, intra-uterine growth retardation <10th percentile, placental abruption, Preterm birth < 37 weeks of gestation, Perinatal death, Maternal death

  A composite morbidity-mortality criterion that includes the occurrence during pregnancy or postpartum of at least one of the following events: preeclampsia, IUGR \<10th percentile, placental abruption, Preterm birth \< 37 weeks of gestation, Perinatal death (death from 22 weeks of gestation until 28 days after birth), Maternal death

  9 months

Secondary Outcomes (18)

• IUGR (< 10th percentile of birth weight)

  9 months

• Placental abruption

  9 months

• Preterm birth < 37 weeks of gestation

  9 months

• Maternal death

  9 months

• Severe pre-eclampsia

  9 months

Study Arms (2)

Aspirin 150 mg

EXPERIMENTAL

Aspirin 150 mg / day (acetylsalicylic acid) once daily in the evening

Drug: Aspirin 150 mg

Placebo

PLACEBO COMPARATOR

Placebo taken in the evening

Drug: Placebo

Interventions

Aspirin 150 mg DRUG

Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.

Also known as: Active arm

Aspirin 150 mg

Placebo DRUG

Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.

Also known as: comparator arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (20)

CHU Bordeaux

Bordeaux, France

RECRUITING

CHU Caen

Caen, 14000, France

WITHDRAWN

CHU Antoine Béclère, AP-HP

Clamart, France

RECRUITING

Hôpital Louis Mourier, AP-HP

Colombes, France

RECRUITING

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, 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

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Perinatal Death; Abruptio Placentae

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death; Obstetric Labor Complications; Placenta Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Edouard LE CARPENTIER

CONTACT

01 45 17 50 00; Edouard.Lecarpentier@chicreteil.fr

Camille JUNG

CONTACT

01 45 17 50 00; camille.jung@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treatment will be administered double blind. Pouches or tablets and caskets will be indistinguishable, prepared in advance and made available to pharmacies in participating hospitals by the sponsor. The treatment boxes are given as the monthly visits to the patient, a reassignment box will be required on the server at each visit to obtain a new cabinet number. The cabinet number (detachable label) used at each visit will be reported in the patient's file.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicentric randomized double-blind superiority trial, placebo-controlled, on two parallel arms

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: February 15, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2030
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)