Acetylsalicylic acid for Pregnancy-associated hypertension | Pre-eclampsia | Fetal growth restriction

Inclusion criteria

• {"criterion_text":"- Pregnant women between 10 weeks and 19 weeks + 6 days"}
• {"criterion_text":"- Chronic hypertension, whether treated or not"}
• {"criterion_text":"- ­Singleton pregnancy"}
• {"criterion_text":"- Signed the written informed consent"}
• {"criterion_text":"- Affiliation to social security"}

Exclusion criteria

• {"criterion_text":"- Medical history requiring anticoagulation (antiphospholipid syndrome, deep vein thromboembolic disease, pulmonary embolism, atherothrombosis, patient with mechanical heart valves),"}
• {"criterion_text":"- Human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus positive serum,"}
• {"criterion_text":"- Patient included in another interventional study which could interfere with the results of the study"}
• {"criterion_text":"- Age <18 years old,"}
• {"criterion_text":"- Geographic inaccessibility (less likely to comply with necessary follow-up visits and Care),"}
• {"criterion_text":"- Women under the protection of justice,"}
• {"criterion_text":"- Patients with psychiatric follow-up, poor understanding of French or cognitive problems."}
• {"criterion_text":"- Duodenal ulcer,"}
• {"criterion_text":"- Severe renal impairment,"}
• {"criterion_text":"- Severe hepatic insufficiency,"}
• {"criterion_text":"- Severe cardiac impairment"}
• {"criterion_text":"- Patient receiving aspirin for another indication outside pregnancy"}
• {"criterion_text":"- Gout"}
• {"criterion_text":"- Patients with known glucose-6-phosphate dehydrogenase deficiency,"}
• {"criterion_text":"- Patient with significant proteinuria (> 300mg/24 hours or a proteinuria/creatininuria ratio ≥ 30mg/mmol),"}
• {"criterion_text":"- Active bleeding,"}
• {"criterion_text":"- History of severe PE with delivery < 34 weeks of gestation,"}
• {"criterion_text":"- Hypersensitivity to salicylates such as aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs)"}
• {"criterion_text":"- Platelet count lower than 100,000 cells/microliter (dosage less than 6 months old),"}
• {"criterion_text":"- Hemostasis disorders, including hemophilia (with thrombocytopenia)"}
• {"criterion_text":"- Any constitutional or acquired hemorrhagic disease, (including digestive haemorrhages, history of haemorrhagic stroke and thrombocytopenia"}

Primary endpoints

• {"endpoint_text":"- It is a composite morbidity-mortality criterion comprising at least one of the following: ­\tPreeclampsia (early or late) ­\tBirthweight <10 percentile ­\tPlacental abruption ­\tPerinatal death ­\tMaternal death ­\tPreterm delivery < 37 weeks of gestation","definition_or_measurement_approach":"Composite morbidity-mortality criterion comprising at least one of the listed events (preeclampsia early/late; birthweight <10th percentile; placental abruption; perinatal death; maternal death; preterm delivery <37 weeks)."}

Secondary endpoints

• {"endpoint_text":"- Rate of the composite morbidity-mortality criterion in 2 subgroups: treatment started before or after 15 SA","definition_or_measurement_approach":"Comparison of composite endpoint rate between subgroups defined by treatment initiation before versus after 15 weeks of amenorrhea (SA)."}
• {"endpoint_text":"- Each of the events of primary end-point taken individually,","definition_or_measurement_approach":"Incidence rates for each component of the primary composite endpoint measured individually (preeclampsia, birthweight <10th percentile, placental abruption, perinatal death, maternal death, preterm delivery)."}
• {"endpoint_text":"- Rate of severe PE","definition_or_measurement_approach":"Incidence rate of severe pre-eclampsia as per study definitions."}
• {"endpoint_text":"- Rate of severe IUGR (< 5th percentile of birth weight),","definition_or_measurement_approach":"Incidence of severe intrauterine growth restriction defined as birth weight <5th percentile."}
• {"endpoint_text":"- Rate of severe preterm delivery (< 34 weeks of gestation),","definition_or_measurement_approach":"Incidence of preterm delivery before 34 weeks' gestation."}
• {"endpoint_text":"- Rate of fetal loss (fetal loss between 10 and 21 weeks of gestation),","definition_or_measurement_approach":"Incidence of fetal loss occurring between 10 and 21 weeks' gestation."}
• {"endpoint_text":"- Rate of fetal death (fetal death from 22 weeks of gestation until delivery),","definition_or_measurement_approach":"Incidence of fetal death from 22 weeks' gestation until delivery."}
• {"endpoint_text":"- Rate of neonatal death (death from birth until 28 days),","definition_or_measurement_approach":"Incidence of neonatal death occurring from birth up to 28 days of life."}
• {"endpoint_text":"- Neonatal morbidity \tstay in a neonatal intensive care unit, \tassisted ventilation > 24 hours, \thyaline membrane disease, \tintraventricular hemorrhages stage III or IV,","definition_or_measurement_approach":"Composite neonatal morbidity elements: NICU stay; assisted ventilation >24 hours; hyaline membrane disease; intraventricular hemorrhage stage III or IV."}
• {"endpoint_text":"- Potential toxicity of the treatment: major maternal bleeding event (active externalized, intracranial, intra-ocular, retroperitoneal, articular), or minor","definition_or_measurement_approach":"Assessment of maternal bleeding events categorized as major (externalized active bleeding, intracranial, intraocular, retroperitoneal, articular) or minor."}
• {"endpoint_text":"- Adherence of treatment (diary) and its relationship with the efficacy of the preventive effect on primary outcome,","definition_or_measurement_approach":"Patient-reported treatment adherence (diary) and analysis of association between adherence and primary outcome efficacy."}
• {"endpoint_text":"- Biological response to the treatment (response to the treatment will be defined as a serum thromboxane B2 > 10ng/mL)","definition_or_measurement_approach":"Response defined as serum thromboxane B2 > 10 ng/mL."}
• {"endpoint_text":"- Circulating and urinary angiogenic profile associated with maternal and fetal clinical data: sFLT1 (serum and urine), PlGF (serum and urine)","definition_or_measurement_approach":"Systematic assay of circulating and urinary angiogenic factors sFlt-1 and PlGF in serum and urine correlated with clinical data."}
• {"endpoint_text":"- Child psychomotor development and health problems at 2 and 4 years of age","definition_or_measurement_approach":"Assessment of child psychomotor development and health issues at age 2 and 4 years (details per protocol assessments)."}

France

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

487

Number Of Sites

17

Number Of Participants

500

Primary sponsor

Full Name

Centre Hospitalier Intercommunal Creteil

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France