Aspirin for the Prevention of Preeclampsia and Pregnancy outcomes in nulliparous women after Assisted Reproductive Technology.

Recruiting

• Conditions: Preeclampsia during pregnancy

• Registration Number: 2022-500933-10-00
• Lead Sponsor: Centre Hospitalier Universitaire De Toulouse

Brief Summary

Evaluate the effect of aspirin 150mg daily initiated between 9 and 15(+6 days) weeks of gestation versus placebo in the prevention of preterm (<37 weeks of gestation) preeclampsia in nulliparous pregnant women after assisted reproductive technology.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2022-10-18
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Female
• Target Recruitment: 1164

Inclusion Criteria

Nulliparous women aged 18 years or more

Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), oocyte donation or intrauterine insemination with sperm donor

Singleton pregnancy

Evolutive pregnancy between 9 and 15 (+6 days) weeks of gestation

Women affiliated to a French Social Security Insurance or equivalent social protection

Written informed consent

Exclusion Criteria

Major fetal abnormality

Regular treatment with aspirin (including antiphospholipid syndrome)

Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration, hemophilia)

Women protected by law.

Patient included in another drug study or another interventional study which could interfere with the results of the study

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of preterm (<37 weeks of gestation) preeclampsia (binary variable yes/no).		Occurrence of preterm (<37 weeks of gestation) preeclampsia (binary variable yes/no).

Secondary Outcome Measures

Name	Time	Method
Occurrence of spontaneous and total preterm birth (defined by delivery at <34 weeks of gestation)		Occurrence of spontaneous and total preterm birth (defined by delivery at <34 weeks of gestation)
Occurrence of spontaneous and total preterm birth (defined by delivery at <37weeks of gestation)		Occurrence of spontaneous and total preterm birth (defined by delivery at <37weeks of gestation)
Occurrence of term (≥37 weeks) preeclampsia.		Occurrence of term (≥37 weeks) preeclampsia.
Occurrence of preeclampsia before 34 weeks of gestation.		Occurrence of preeclampsia before 34 weeks of gestation.
Occurrence of cesarean delivery.		Occurrence of cesarean delivery.
Occurrence of postpartum hemorrhage (>500ml)		Occurrence of postpartum hemorrhage (>500ml)
Occurrence of placental abruption		Occurrence of placental abruption
Occurrence of stillbirth		Occurrence of stillbirth
Birthweight		Birthweight
Occurrence of severe maternal morbidity (occurrence of at least one of the following: severe postpartum hemorrhage (>1000ml), treatment of postpartum hemorrhage by embolization, vascular ligature, hysterectomy, secondary post-partum hemorrhage, pulmonary embolism, cardiovascular complications, neuropsychological complications, maternal transfer to intensive care unit, maternal death).		Occurrence of severe maternal morbidity (occurrence of at least one of the following: severe postpartum hemorrhage (>1000ml), treatment of postpartum hemorrhage by embolization, vascular ligature, hysterectomy, secondary post-partum hemorrhage, pulmonary embolism, cardiovascular complications, neuropsychological complications, maternal transfer to intensive care unit, maternal death).
Neonatal death (before 28 days of life) or occurrence of neonatal complications including intraventricular hemorrhage grade II or above, sepsis with confirmed bacteremia in cultures, anemia requiring blood transfusion, respiratory distress syndrome treated with surfactant and ventilation, necrotizing enterocolitis requiring surgery, intensive care unit admission, ventilation with positive airway pressure or intubation.		Neonatal death (before 28 days of life) or occurrence of neonatal complications including intraventricular hemorrhage grade II or above, sepsis with confirmed bacteremia in cultures, anemia requiring blood transfusion, respiratory distress syndrome treated with surfactant and ventilation, necrotizing enterocolitis requiring surgery, intensive care unit admission, ventilation with positive airway pressure or intubation.
Occurrence of maternal expected adverse events (any bleeding, headache, nausea, skin rash, dyspepsia, abdominal pain) recorded from randomization and until hospital discharge after delivery		Occurrence of maternal expected adverse events (any bleeding, headache, nausea, skin rash, dyspepsia, abdominal pain) recorded from randomization and until hospital discharge after delivery
Adherence to the treatment (by counting the pills at each visit and by using a diary or an application).		Adherence to the treatment (by counting the pills at each visit and by using a diary or an application).
Number of consumed resources and unit costs of hospitalizations, consultations, medical acts, medication, medical devices and transportation.		Number of consumed resources and unit costs of hospitalizations, consultations, medical acts, medication, medical devices and transportation.
Incremental cost-effectiveness from the collective perspective expressed in terms of cost per number of preterm pre-eclampsia avoided from the initiation of aspirin or placebo 1 months after the delivery.		Incremental cost-effectiveness from the collective perspective expressed in terms of cost per number of preterm pre-eclampsia avoided from the initiation of aspirin or placebo 1 months after the delivery.
Occupation, level of income and level of education will be recorded to test the impact of socioeconomic characteristics on the cost of care and efficiency.		Occupation, level of income and level of education will be recorded to test the impact of socioeconomic characteristics on the cost of care and efficiency.

Trial Locations

Locations (21)

GIE Groupe hospitalier Paris Saint-Joseph; 🇫🇷 Paris Cedex 14, France

Centre Hospitalier Regional De Marseille; 🇫🇷 Marseille Cedex 15, France

CHU Gabriel-Montpied; 🇫🇷 Clermont Ferrand, France

Trousseau Hospital; 🇫🇷 Paris, France

Chru De Nancy; 🇫🇷 Nancy, France

Centre Hospitalier Universitaire De Poitiers; 🇫🇷 Poitiers, France

Centre Hospitalier Intercommunal De Poissy Saint Germain; 🇫🇷 Poissy, France

Centre Hospitalier Universitaire De Dijon; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes, France

Centre Hospitalier Regional D'angers; 🇫🇷 Angers, France

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GIE Groupe hospitalier Paris Saint-Joseph

🇫🇷Paris Cedex 14, France

Elie AZRIA

Site contact

0144123729

eazria@ghpsj.fr