Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:

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Pre-Eclampsia Drug: ASA-withdrawn group Phase 3

Detailed Description:
The main objective of the study is to demonstrate that in patients considered to be at high risk for PE (from the first-trimester screening) and with sFlt-1/PlGF ratio <38, between 24+0 and 27+6 weeks, the incidence of PE, after cessation of the treatment with ASA, will not be superior to that of the control group.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A phase III, multicentric, Randomized, open-label, parallel-group clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years old
  • Gestational age below 28+0 weeks
  • Single pregnancy
  • High-risk for pre-eclampsia from the first-trimester screening for pre-eclampsia
  • ASA treatment started before or at 16+6 weeks of gestation
  • Maternal sFlt-1/PlGF ratio at 24+0-27+6 weeks of gestation
  • Signed informed consent

Exclusion Criteria:

  • Multiple pregnancy
  • Dead and/or fetal polymalformation, including also any fetal genetical and/or chromosomic disease.
  • Von Willebrand disease.
  • ASA intolerance and /or allergy
  • Peptic ulcer
  • ASA compliance <50% before inclusion
  • Patients with misunderstanding or not able to understand the protocol, including also any condition which could compromise the compliance of the protocol, according to the investigator's opinion.
  • No signature of the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741179


Contacts
Layout table for location contacts
Contact: Manel Mendoza Cobaleda, MD, PhD +34 934 893 000 ext 2702 aro@vhir.org
Contact: Mercedes Villa +34 934 893 000 ext 2702 mercedes.villa@vhir.org

Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Manel Mendoza Cobaleda, MD, PhD Vall d'Hebron Institut de Recerca (VHIR)

Layout table for additonal information
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03741179     History of Changes
Other Study ID Numbers: STOPPRE
2018-000811-26 ( EudraCT Number )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
pre-eclampsia
pregnant
sFlt-1/PlGF ratio
ASA treatment

Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications