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CHASAP : Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy, a multicenter prospective randomized double-blind placebo-controlled trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516461-36-00
Acronym
CHASAP
Enrollment
500
Registered
2024-10-17
Start date
2021-01-27
Completion date
Unknown
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy associated hypertension, Pre-Eclampsia, Fetal growth restriction

Brief summary

It is a composite morbidity-mortality criterion comprising at least one of the following: ­ Preeclampsia (early or late) ­ Birthweight <10 percentile ­ Placental abruption ­ Perinatal death ­ Maternal death ­ Preterm delivery < 37 weeks of gestation

Detailed description

Rate of the composite morbidity-mortality criterion in 2 subgroups: treatment started before or after 15 SA, Each of the events of primary end-point taken individually,, Rate of severe PE, Rate of severe IUGR (< 5th percentile of birth weight),, Rate of severe preterm delivery (< 34 weeks of gestation),, Rate of fetal loss (fetal loss between 10 and 21 weeks of gestation),, Rate of fetal death (fetal death from 22 weeks of gestation until delivery),, Rate of neonatal death (death from birth until 28 days),, Neonatal morbidity  stay in a neonatal intensive care unit,  assisted ventilation > 24 hours,  hyaline membrane disease,  intraventricular hemorrhages stage III or IV,, Potential toxicity of the treatment: major maternal bleeding event (active externalized, intracranial, intra-ocular, retroperitoneal, articular), or minor, Adherence of treatment (diary) and its relationship with the efficacy of the preventive effect on primary outcome,, Biological response to the treatment (response to the treatment will be defined as a serum thromboxane B2 > 10ng/mL), Circulating and urinary angiogenic profile associated with maternal and fetal clinical data: sFLT1 (serum and urine), PlGF (serum and urine), Child psychomotor development and health problems at 2 and 4 years of age

Interventions

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
It is a composite morbidity-mortality criterion comprising at least one of the following: ­ Preeclampsia (early or late) ­ Birthweight <10 percentile ­ Placental abruption ­ Perinatal death ­ Maternal death ­ Preterm delivery < 37 weeks of gestation

Secondary

MeasureTime frame
Rate of the composite morbidity-mortality criterion in 2 subgroups: treatment started before or after 15 SA, Each of the events of primary end-point taken individually,, Rate of severe PE, Rate of severe IUGR (< 5th percentile of birth weight),, Rate of severe preterm delivery (< 34 weeks of gestation),, Rate of fetal loss (fetal loss between 10 and 21 weeks of gestation),, Rate of fetal death (fetal death from 22 weeks of gestation until delivery),, Rate of neonatal death (death from birth until 28 days),, Neonatal morbidity  stay in a neonatal intensive care unit,  assisted ventilation > 24 hours,  hyaline membrane disease,  intraventricular hemorrhages stage III or IV,, Potential toxicity of the treatment: major maternal bleeding event (active externalized, intracranial, intra-ocular, retroperitoneal, articular), or minor, Adherence of treatment (diary) and its relationship with the efficacy of the preventive effect on primary outcome,, Biological response to the treatment (r

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026