Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05521776 En recrutement IDF

Titre

Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial (RANSPRE)

Type

Interventional

Pathologie

Pré-éclampsie

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

mars 2023

Date de fin

octobre 2025

Dernière mise à jour

29 juin 2024

Résumé

The purpose of this study is to determine whether first-trimester screening for preeclampsia based on the FMF algorithm (a combination of maternal clinical, sonographic and biochemical parameters), improves maternal or perinatal health.

Détail

Voir le détail Preeclampsia (PE) complicates 2% of pregnancies and is a leading cause of severe maternal and perinatal complications. There is no curative treatment, and the only recognized beneficial primary prevention is low-dose aspirin. Meta-analyses of randomized trials show that the administration of aspirin, started before 16 weeks of gestation (WG) and at the dosage of 100-160 mg/d in pregnant women at high risk of PE, is associated with a 50% to 60% reduction in the rates of PE, prematurity and perinatal mortality. The group of patients benefiting most from aspirin is pregnant women with a history of PE. That is why all guidelines recommend early preventive administration of aspirin in pregnant women with PE in a previous pregnancy. However, patients with a history of PE represent a small fraction of pregnant women, and PE mostly occurs in women who do not have a history of PE, especially nulliparas. Recently, several national societies decided to broaden the indications for aspirin prevention on the basis of the number of known maternal risk factors. These recommendations lead to a wide use of low-dose aspirin in up to 30% of pregnant women. In order to better target patients at risk of PE among all pregnant women, screening tests have been developed integrating clinical characteristics, uterine Doppler (UD) parameters and biomarkers in a single score. The study by Poon et al. paved the way for early detection of PE. An algorithm based on maternal characteristics, UD parameters and serum levels of PlGF and PAPP-A between 11 and 14 WG yielded detection rates of 93% and 36% for the prediction of early- and late-onset PE, respectively, at 5% false-positive rate (FPR), which were superior to the detection rates of the traditional checklist-based approach, which relies on maternal factors only. This algorithm developed by the Fetal Medicine Foundation (FMF) has since evolved and is now integrated in the combined test for PE screening known as the FMF triple test (a combination of maternal characteristics with mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), and serum PlGF). In a subsequent study using a risk cutoff of 1 in 100 for the predicted probability of preterm PE, a screen-positive rate of 10% has been reported, with detection rates for early-onset, preterm, and term PE of 88%, 69%, and 40%, respectively. Recently, the ASPRE study evaluated the impact of aspirin in patients identified at high risk of PE on the basis of this FMF test. Screening was offered to 26,941 women and identified 2,641 high-risk patients of whom 1,776 were randomized to aspirin or placebo. This trial showed a reduction in the incidence of PE <37 WG, occurring in 13/798 in the aspirin group versus 35/822 in the placebo group (p=0.004), but with no significant effect on the overall rate of PE and most importantly on perinatal morbidity. Screening had to be applied to almost 27,000 women for a benefit of 22 avoided cases of preterm PE, with no demonstrated effect on the health of the women and children. The ASPRE study is important but does not demonstrate the benefit of routinely implementing PE screening in the general population. Indeed, there is currently no randomized study comparing a group of women to which the screening procedure would be applied to a group of women without screening, the only design able to provide strong evidence of a benefit. In addition, implementing a national screening program in pregnant women may induce adverse events, especially iatrogenicity (more hospitalizations, more ultrasound examinations, more consultations) and anxiety. Such a screening program is also associated with an increase of direct and indirect health costs. To consider implementing screening for PE in the general population, it is then essential to demonstrate its benefits on robust health outcomes and not only on the PE diagnosis, as well as to assess its potential adverse consequences and costs. This evaluation is all the more crucial since it is currently offered to an increasing number of women. The RANSPRE study will therefore be the first trial to test the impact on perinatal and maternal health outcomes of first-trimester screening for preeclampsia associated with aspirin treatment of pregnant women screened at risk. A medical and economic evaluation allowing a cost-effectiveness analysis will also be carried out. The results of this study will constitute essential information relevant to the health care system that will guide policymaking for the prevention of PE in the general population of pregnant women. The primary objective of the study is to evaluate the impact of first-trimester PE screening (FTPS) on the incidence of severe perinatal morbidity. The primary outcome will be severe perinatal morbidity defined by a composite criterion including at least one of the following: perinatal mortality (stillbirth at or after 20 WG or neonatal death within 7 days of life) or prematurity <34 WG or birth weight <3° percentile for gestational age. Secondary objectives are: (i) to evaluate the impact of first-trimester PE screening on: the incidence of preeclampsia, the incidence of components of moderate and severe maternal morbidity, the incidence of components of moderate and severe perinatal morbidity; (ii) to evaluate the impact of first-trimester PE screening on potential adverse events: iatrogenicity, over-medicalization, women's satisfaction and anxiety status; (iii) to evaluate the economic impact of first-trimester PE screening on costs. Patients will be recruited in 22 maternity centers at university hospitals in France. The inclusion period during pregnancy is between 11 WG and 14 WG. Eligible women will be identified in early pregnancy at their first prenatal visit in the maternity hospital, before or at the time of the first-trimester ultrasound. The FMF algorithm used in the study for PE screening is based on a combination of maternal clinical parameters (medical history, maternal characteristics, pregnancy characteristics, mean arterial pressure), sonographic parameters (uterine Doppler with measurement of mean pulsatility index) and biochemical parameters (PlGF concentration). Women agreeing to participate in the RANSPRE trial will be randomized either to the experimental group with first-trimester screening for PE or to the control group with usual care without screening for PE. All patients will be asked to complete self-administered questionnaires at 20 (+/2) WG (given during routine prenatal visit or sent by mail) and at day 2 postpartum (during postpartum stay) assessing their satisfaction and anxiety. A notebook will be given to patients screened at risk and with aspirin prescription to monitor aspirin observance and to record potential side-effects related to aspirin. An intention-to-treat analysis will be performed as the principal analysis. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Antoine Béclère	TSATSARIS Vassilis	En recrutement IDF	02/12/2024 12:47:35	Contacter
AP-HP - Hôpital Armand Trousseau-La Roche Guyon	TSATSARIS Vassilis	En recrutement IDF	02/12/2024 12:47:35	Contacter
AP-HP - Hôpital Cochin	TSATSARIS Vassilis	En recrutement IDF	02/12/2024 12:47:35	Contacter
CHI DE CRETEIL	Edouard LECARPENTIER	En recrutement IDF	29/03/2024 01:30:38	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
GH PARIS SITE SAINT JOSEPH	Elie AZRIA, Pr	En recrutement IDF		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHI de Poissy - Poissy - France	Paul BERVEILLER, Pr	En recrutement		Contact (sur clinicalTrials)
CHRU de Nancy - Nancy - France	Olivier MOREL, MD, PhD	En recrutement		Contact (sur clinicalTrials)
CHU Angers - Angers - France		En recrutement		Contact (sur clinicalTrials)
CHU Charles Nicolle - Rouen - France	Eric VERSPYCK, Pr	En recrutement		Contact (sur clinicalTrials)
CHU de Bordeaux - Bordeaux - France	Loïc SENTILHES, Pr	En recrutement		Contact (sur clinicalTrials)
CHU Dijon Bourgogne - Dijon - France	Emmanuel SIMON, Dr	En recrutement		Contact (sur clinicalTrials)
CHU Estaing - Clermont-Ferrand - France	Denis GALOT, Dr	En recrutement		Contact (sur clinicalTrials)
CHU Lille - Lille - France		Recrutement non commencé		Contact (sur clinicalTrials)
CHU Strasbourg, CMCO Schiltigheim - Strasbourg - France	AS WEINGERTNER, Dr	En recrutement		Contact (sur clinicalTrials)
Hôpital Antoine Béclère - Clamart - France	Alexandra LETOURNEAU, Dr	En recrutement		Contact (sur clinicalTrials)
Hôpital Bretonneau - Tours - France	Franck PERROTIN, Pr	En recrutement		Contact (sur clinicalTrials)
Hôpital de Hautepierre - Strasbourg - France	Anne-Sophie WEINGERTNER, Dr	En recrutement		Contact (sur clinicalTrials)
Hôpital de la conception et de la Timone - Marseille - France	Florence BRETELLE, Pr	En recrutement		Contact (sur clinicalTrials)
Hôpital Femme - Maternité - Nantes - France	Norber WINER, Pr	En recrutement		Contact (sur clinicalTrials)
Hôpital Femme Mère Enfant - Bron - France	Anthony ATTALAH, Dr	En recrutement		Contact (sur clinicalTrials)
Hôpital Intercommunal Créteil - Créteil - France	Edouard LECARPENTIER, Dr	En recrutement		Contact (sur clinicalTrials)
Hôpital Nord - Marseille - France	Julie BLANC, Dr	En recrutement		Contact (sur clinicalTrials)
Hôpital Paule de Viguier - Toulouse - France	Paul GUERBY, Dr	En recrutement		Contact (sur clinicalTrials)
Hôpital Sud Rennes - Rennes - France	Maela LELOUS, Dr	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Femme

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria :

- Pregnancy between 11 and 14 WG

- Age ≥18 years

- Affiliated to or beneficiary of a health insurance system (including AME)

- Signed informed consent

Exclusion Criteria :

- Gestational age <11 WG and >14 WG

- Known ectopic pregnancy

- Known non-ongoing pregnancy

- Known multiple pregnancy

- History of PE in a previous pregnancy

- Pregnancies complicated by major fetal abnormality identified at the first-trimester
ultrasound if performed before randomization

- Absence of health insurance

- Contra-indication to aspirin (bleeding disorders such as von Willebrand's disease,
active peptic ulceration, hypersensitivity to aspirin, active peptic ulceration,
NSAID-exacerbated respiratory disease, severe liver or heart dysfunction)

- Women taking low-dose aspirin regularly before pregnancy (except ART indication)

- Age <18 years

- Poor understanding of the French language

Critère de non inclusion

NCT05521776 - Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial (RANSPRE)

Informations générales
Etablissements
Critères
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