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Clinical Trial NCT04356326 (CHASAP) for Chronic Hypertension Complicating Pregnancy, Pre-Eclampsia, Intrauterine Growth Restriction, Aspirin, Perinatal Death, Placental Abruption is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy (CHASAP) Phase 3 500 Randomized Pregnancy Prevention

Recruiting
Clinical Trial NCT04356326 (CHASAP) is designed to study Treatment for Chronic Hypertension Complicating Pregnancy, Pre-Eclampsia, Intrauterine Growth Restriction, Aspirin, Perinatal Death, Placental Abruption. It is a Phase 3 interventional study that is recruiting, having started on 15 February 2021, with plans to enroll 500 participants. Led by Centre Hospitalier Intercommunal Creteil, it is expected to complete by 1 February 2030. The latest data from ClinicalTrials.gov was last updated on 2 September 2025.
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.
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 preeclampsia (PE), placental abruption, Intra Uterine Growth Restriction (IUGR), perinatal death, maternal death, or preterm delivery. To date, there is no curative treatment of vascular complications of chronic hypertensi...Show More
Official Title

Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.

Conditions
Chronic Hypertension Complicating PregnancyPre-EclampsiaIntrauterine Growth RestrictionAspirinPerinatal DeathPlacental Abruption
Other Study IDs
  • CHASAP
  • 2018-004160-58 (EudraCT Number)
NCT ID Number
NCT04356326
Start Date (Actual)
2021-02-15
Last Update Posted
2025-09-02
Completion Date (Estimated)
2030-02
Enrollment (Estimated)
500
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAspirin 150 mg
Aspirin 150 mg / day (acetylsalicylic acid) once daily in the evening
Aspirin 150 mg
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.
Placebo ComparatorPlacebo
Placebo taken in the evening
Placebo
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
IUGR (< 10th percentile of birth weight)
Rate of IUGR (\< 10th percentile of birth weight)
9 months
Placental abruption
Rate of placental abruption
9 months
Preterm birth < 37 weeks of gestation
Rate of severe preterm delivery (\< 37 weeks of gestation)
9 months
Maternal death
Rate of severe maternal death
9 months
Severe pre-eclampsia
Rate of severe pre-eclampsia. Concerning the rate of superimposed PE, it will be analyze according the two definition specified in the rational
9 months
Intrauterine growth restriction (IUGR)
Rate of severe IUGR (\< 5th percentile of birth weight)
9 months
Preterm delivery
Rate of severe preterm delivery (\< 34 weeks of gestation)
8 months
Fetal loss
Rate of fetal loss (fetal loss between 10 and 21 weeks of gestation)
5 months
Fetal death
Rate of fetal death (fetal death from 22 weeks of gestation until delivery)
5 months
Neonatal death
Rate of neonatal death (death from birth until 28 days)
9 months
Neonatal morbidity
Neonatal morbidity (stay in a neonatal intensive care unit, assisted ventilation \> 24 hours, hyaline membrane disease, intraventricular hemorrhages stage III or IV)
9 months
Toxicity of aspirin
Potential toxicity of the treatment: major maternal bleeding event (active externalized, intracranial, intra-ocular, retroperitoneal, articular), or minor,
8 months
Adherence
Adherence of treatment (diary) and its relationship with the efficacy of the preventive effect on primary outcome,
8 months
Biological response to the treatment
Response to the treatment by a urine thromboxane assay
4 months
Angiogenic profile
Circulating and urinary angiogenic profile associated with maternal and fetal clinical data: sFLT1 ( Soluble fms-like tyrosine kinase-1)(serum and urine), PlGF ( Placental Growth Factor)(serum and urine)
9 months
Child development
Child psychomotor development and health problems at 2 years of age
2 years
Child development
Child psychomotor development and health problems at 4 years of age
4 years
Subgroups analysis
Rate of the composite morbidity-mortality criterion in 2 subgroups: treatment started before or after 15 SA
9 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • ---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,
Centre Hospitalier Intercommunal Creteil logoCentre Hospitalier Intercommunal Creteil
Study Central Contact
Contact: Edouard LE CARPENTIER, 01 45 17 50 00, [email protected]
Contact: Camille JUNG, 01 45 17 50 00, [email protected]
20 Study Locations in 1 Countries
CHU Bordeaux, Bordeaux, France
Loïc SENTILHES, Contact
Recruiting
CHU Caen, Caen, 14000, France
Withdrawn
CHU Antoine Béclère, AP-HP, Clamart, France
Alexandra BENACHI, Contact
Recruiting
Hôpital Louis Mourier, AP-HP, Colombes, France
Jeanne SIBIUDE, Contact
Recruiting
Centre Hospitalier Intercommunal de Créteil, Créteil, 94000, France
Edouard LECARPENTIER, Ph, Contact, 01 57 02 50 00, [email protected]
Recruiting
CHU Dijon, Dijon, France
Emmanuel SIMON, Contact
Recruiting
CHU Bicêtre, AP-HP, Le Kremlin-Bicêtre, France
Claire SZMULEWICZ, Contact
Recruiting
CHRU Lille, Lille, France
Louise GHESQUIERE, Contact
Not yet recruiting
CHU Lyon, Lyon, France
Jérôme MASSARDIER, Contact
Recruiting
Hôpital St Joseph, Marseille, France
Withdrawn
CHRU Nancy, Nancy, France
Withdrawn
CHU Nantes, Nantes, France
Norbert WINER, Contact
Recruiting
CHU Cochin- Port Royal, AP-HP, Paris, France
Vassilis TSATSARIS, Contact
Recruiting
CHU Robert Débré, AP-HP, Paris, France
Diane KORB, Contact
Recruiting
CHU Tenon, Paris, France
Anne-Gaël CORDIER, Contact
Recruiting
Hôpital Trousseau, AP-HP, Paris, France
Pierre DELORME, Contact
Recruiting
CH Poissy, Poissy, France
Paul BERVEILLER, Contact
Recruiting
CHU St Etienne, Saint-Etienne, France
Tiphaine BARJAT, Contact
Recruiting
CHU Toulouse, Toulouse, France
Paul GUERBY, Contact
Not yet recruiting
CHU Tours, Tours, France
Withdrawn