Detection of False Positives From First-trimester Preeclampsia Screening (StopPRE) at the Second-trimester of Pregnancy (StopPRE)
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|ClinicalTrials.gov Identifier: NCT03741179|
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : February 21, 2019
Pregnant women at a higher risk for early-onset pree-clampsia (PE) should be offered preventive daily treatment with acetylsalicylic acid (ASA) started before 16 weeks of gestation. To select patients at higher risk for early-onset PE, multiparametric assessment combining maternal history, biochemical factors and biophysical factors should be used during the first trimester of pregnancy. Multiparametric risk assessments have a detection rate for early-onset PE around 80% at a false positive rate of 10%. Owing to the low prevalence of early-onset PE, more than 90% of patients considered at high risk, at the first-trimester screening, will not eventually develop PE. Thus, ASA treatment would be innecessary and could be safely discontinued in these patients.
The sFlt-1 to PlGF ratio has a high negative predictive value for PE during the second and third trimester of pregnancy. Thus, it could be used to detect false-positive patients from the first-trimester screening.
This is a multicentric, randomized, open, parallel, controlled, phase III trial, where 798 patients under treatment with ASA for being at high risk for preeclampsia from the first-trimester screening, will be candidates to participate. Patients with a sFlt-1/PlGF <38, from 24 to 27+6 weeks of gestation will be randomized at a 1:1 ratio and allocated to either continue ASA until 36 weeks or to stop ASA treatment.
|Condition or disease||Intervention/treatment||Phase|
|Pre-Eclampsia||Drug: ASA-withdrawn group||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||878 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A phase III, multicentric, Randomized, open-label, parallel-group clinical trial|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Multicentric, Randomized, Open-label, Parallel-group Clinical Trial to Detect False Positives From First-trimester Preeclampsia Screening (StopPRE) at the Second-trimester of Pregnancy|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: ASA-withdrawn group
ASA treatment will be withdrawn if patients present an sFlt/PlGF < 38 at 24+0-27+6 weeks of gestation.
Drug: ASA-withdrawn group
Patients whith sFlt/PlGF ratio < 38 at 24+0-27+6 weeks will be randomized into two arms of the trial. Patients allocated in the experimental arm will stop the ASA treatment.
Other Name: sFlt y PlGF ratio less than 38.
No Intervention: ASA group
ASA treatment will continue until 36 weeks of gestation if patients present an sFlt/PlGF ratio < 38 at 24+0-27+6 weeks of gestation.
- Rate of pre-eclampsia in both arms of the study (ASA vs no ASA). [ Time Frame: From 24+0 weeks of gestation onwards ]Rate of pre-eclampsia in pregnant women at high-risk for early-onset PE from the first-trimester screening and ratio sFlt-1/PlGF<38 between 24-27+6 weeks of gestation in both arms of the study (ASA vs no ASA).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741179
|Contact: Manel Mendoza Cobaleda, MD, PhD||+34 934 893 000 ext firstname.lastname@example.org|
|Contact: Mercedes Villa||+34 934 893 000 ext email@example.com|
|Principal Investigator:||Manel Mendoza Cobaleda, MD, PhD||Vall d'Hebron Institut de Recerca (VHIR)|