Pre-Eclampsia Clinical Trial
— CHASAPOfficial title:
Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a Multicenter Prospective Randomized Double-blind Placebo-controlled Trial.
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 | Recruiting |
Enrollment | 500 |
Est. completion date | February 2030 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
France | CHU Bordeaux | Bordeaux | |
France | CHU Caen | Caen | |
France | CHU Antoine Béclère, AP-HP | Clamart | |
France | Hôpital Louis Mourier, AP-HP | Colombes | |
France | Centre Hospitalier Intercommunal de Créteil | Créteil | |
France | CHU Dijon | Dijon | |
France | CHU Bicêtre, AP-HP | Le Kremlin-Bicêtre | |
France | CHRU Lille | Lille | |
France | CHU Lyon | Lyon | |
France | Hôpital St Joseph | Marseille | |
France | CHRU Nancy | Nancy | |
France | CHU Nantes | Nantes | |
France | CHU Cochin- Port Royal, AP-HP | Paris | |
France | CHU Robert Débré, AP-HP | Paris | |
France | CHU Tenon | Paris | |
France | Hôpital Trousseau, AP-HP | Paris | |
France | CH Poissy | Poissy | |
France | CHU St Etienne | Saint-Étienne | |
France | CHU Toulouse | Toulouse | |
France | CHU Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Intercommunal Creteil |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | IUGR (< 10th percentile of birth weight) | Rate of IUGR (< 10th percentile of birth weight) | 9 months | |
Secondary | Placental abruption | Rate of placental abruption | 9 months | |
Secondary | Preterm birth < 37 weeks of gestation | Rate of severe preterm delivery (< 37 weeks of gestation) | 9 months | |
Secondary | Maternal death | Rate of severe maternal death | 9 months | |
Secondary | 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 | |
Secondary | Intrauterine growth restriction (IUGR) | Rate of severe IUGR (< 5th percentile of birth weight) | 9 months | |
Secondary | Preterm delivery | Rate of severe preterm delivery (< 34 weeks of gestation) | 8 months | |
Secondary | Fetal loss | Rate of fetal loss (fetal loss between 10 and 21 weeks of gestation) | 5 months | |
Secondary | Fetal death | Rate of fetal death (fetal death from 22 weeks of gestation until delivery) | 5 months | |
Secondary | Neonatal death | Rate of neonatal death (death from birth until 28 days) | 9 months | |
Secondary | 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 | |
Secondary | Toxicity of aspirin | Potential toxicity of the treatment: major maternal bleeding event (active externalized, intracranial, intra-ocular, retroperitoneal, articular), or minor, | 8 months | |
Secondary | Adherence | Adherence of treatment (diary) and its relationship with the efficacy of the preventive effect on primary outcome, | 8 months | |
Secondary | Biological response to the treatment | Response to the treatment by a urine thromboxane assay | 4 months | |
Secondary | 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 | |
Secondary | Child development | Child psychomotor development and health problems at 2 years of age | 2 years | |
Secondary | Child development | Child psychomotor development and health problems at 4 years of age | 4 years | |
Secondary | Subgroups analysis | Rate of the composite morbidity-mortality criterion in 2 subgroups: treatment started before or after 15 SA | 9 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03299777 -
Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan
|
N/A | |
Completed |
NCT03650790 -
C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies
|
N/A | |
Recruiting |
NCT03605511 -
TTP and aHUS in Complicated Pregnancies
|
||
Not yet recruiting |
NCT03302260 -
Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial
|
N/A | |
Completed |
NCT02911701 -
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
|
Phase 4 | |
Completed |
NCT01911494 -
Community Level Interventions for Pre-eclampsia
|
N/A | |
Terminated |
NCT02025426 -
Phenylephrine Versus Ephedrine in Pre-eclampsia
|
Phase 4 | |
Completed |
NCT01352234 -
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
|
Phase 4 | |
Active, not recruiting |
NCT02031393 -
Establishing First Trimester Markers for the Identification of High Risk Twin
|
N/A | |
Terminated |
NCT00141310 -
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
|
Phase 2 | |
Completed |
NCT00157521 -
L-Arginine in Pre-Eclampsia
|
Phase 3 | |
Completed |
NCT04795154 -
Prenatal Yoga as Complementary Therapy of Preeclampsia
|
N/A | |
Completed |
NCT00004399 -
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
|
N/A | |
Completed |
NCT00005207 -
Renin and Prorenin in Pregnancy
|
N/A | |
Recruiting |
NCT04551807 -
Natural Versus Programmed Frozen Embryo Transfer (NatPro)
|
Phase 3 | |
Terminated |
NCT04092829 -
Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer
|
N/A | |
Recruiting |
NCT06067906 -
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
|
N/A | |
Recruiting |
NCT06317467 -
Role of Anti-C1q Autoantibodies in Pregnancy
|
||
Completed |
NCT02218931 -
ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes
|
N/A | |
Active, not recruiting |
NCT04484766 -
Preeclampsia Associated Vascular Aging
|