Detection of False Positives From First-trimester Preeclampsia Screening (StopPRE) at the Second-trimester of Pregnancy (StopPRE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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|Pre-Eclampsia||Drug: ASA-withdrawn group||Phase 3|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 email@example.com|
|Contact: Mercedes Villa||+34 934 893 000 ext firstname.lastname@example.org|
|Principal Investigator:||Manel Mendoza Cobaleda, MD, PhD||Vall d'Hebron Institut de Recerca (VHIR)|