Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
NCT ID: NCT05521776
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
14500 participants
INTERVENTIONAL
2023-03-06
2026-03-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study
NCT00763672
Women's Perspective on First-trimester Preeclampsia Screening
NCT05123560
Predicting Late-onset Preeclampsia at 10-14 Weeks of Pregnancy
NCT04075708
Pregnancy Outcomes in Normotensive VS stage1 Hypertension: a Prospective Observational Study
NCT06339749
Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
NCT03941886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 and during the postpartum period (within 30 days after delivery) assessing women's satisfaction and women's anxiety. These questionnaires will be collected for women included until 31/01/2025.. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
With first trimester preeclampsia screening
Risk assessment of developing preeclampsia between 11 and 14 WG based on maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentration. Patients at high risk of preeclampsia are treated with aspirin.
First-trimester preeclampsia screening (FMF triple test)
An algorithm assessing the risk of developing preeclampsia combining maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentrations.
For women in the screening group, a Doppler study of the uterine arteries and a blood test to quantify PlGF concentrations will be performed within 2 days of randomization, allowing the risk to be calculated according to the screening test. For women with a positive screening test (i.e. predicted risk\> 1/100), a treatment with aspirin will be prescribed at 160 mg/day, started as soon as possible and before 15 WG, and taken up to 36 WG, in the absence of contraindications. For women with negative screening, usual pregnancy monitoring without aspirin will be offered.
Without first trimester preeclampsia screening
Usual prenatal care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
First-trimester preeclampsia screening (FMF triple test)
An algorithm assessing the risk of developing preeclampsia combining maternal parameters, blood pressure measurement, Doppler measurements of the uterine arteries and maternal PlGF concentrations.
For women in the screening group, a Doppler study of the uterine arteries and a blood test to quantify PlGF concentrations will be performed within 2 days of randomization, allowing the risk to be calculated according to the screening test. For women with a positive screening test (i.e. predicted risk\> 1/100), a treatment with aspirin will be prescribed at 160 mg/day, started as soon as possible and before 15 WG, and taken up to 36 WG, in the absence of contraindications. For women with negative screening, usual pregnancy monitoring without aspirin will be offered.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years
* Affiliated to or beneficiary of a health insurance system (including AME)
* Signed informed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
URC-CIC Paris Descartes Necker Cochin
OTHER
INSERM, Epopé team
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Catherine DENEUX, MD, PhD
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Angers
Angers, , France
CHU de Bordeaux
Bordeaux, , France
Hôpital Femme Mère Enfant
Bron, , France
Hôpital Antoine Béclère
Clamart, , France
CHU Estaing
Clermont-Ferrand, , France
Hôpital Intercommunal Créteil
Créteil, , France
CHU Dijon Bourgogne
Dijon, , France
CHU Lille
Lille, , France
Hôpital de la conception et de la Timone
Marseille, , France
Hôpital Nord
Marseille, , France
CHRU de Nancy
Nancy, , France
Hôpital Femme - Maternité
Nantes, , France
Hôpital Armand Trousseau
Paris, , France
Hôpital Cochin (site Port-Royal)
Paris, , France
Hôpital Saint-Joseph
Paris, , France
CHI de Poissy
Poissy, , France
Hôpital Sud Rennes
Rennes, , France
CHU Charles Nicolle
Rouen, , France
CHU Strasbourg, CMCO Schiltigheim
Strasbourg, , France
Hôpital de Hautepierre
Strasbourg, , France
Hôpital Paule de Viguier
Toulouse, , France
Hôpital Bretonneau
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
[email protected]
Role: backup
AS WEINGERTNER, Dr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-A00374-39
Identifier Type: OTHER
Identifier Source: secondary_id
APHP211047
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.