Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767438
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2021-02-19
Brief Title:
Preeclampsia Sequential Screening Using Angiogenic Factors During First Trimester of Pregnancy
Sponsor:
Instituto de Investigación Sanitaria Aragón
Organization:
Instituto de Investigación Sanitaria Aragón
Study Overview
Official Title:
STUDY PROTOCOL FOR A PROSPECTIVE MULTICENTRE COHORT STUDY Preeclampsia Sequential Screening Using Angiogenic Factors During First Trimester of Pregnancy CRISP STUDY
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRISP
Brief Summary:
Preeclampsia PE affects from 2 to 8 of pregnant women Recent studies show that prevention is the best strategy to improve perinatal outcomes Therefore the development of new strategies for preeclampsia screening becomes essential in order to determine the individual risk for each patient and thus to identify those who would be candidates for receiving prophylactic treatment with low-dose aspirin from the first trimester of pregnancy The aim of our study is to determine prospectively during clinical practice the predictive and preventive capacity of a model of preeclampsia sequential screening in the first trimester of pregnancy
This is a prospective multicentre cohort study with the collaboration of Hospital de la Santa Creu i Sant Pau Barcelona Hospital Universitario de Cruces Bilbao Hospital Son Llàtzer Mallorca and Hospital Clínico Universitario Lozano Blesa Zaragoza Women with a singleton pregnancy attending to the 12-week ultrasound scan at one of the maternity hospitals participating in the study between March 1st 2021 and 30th October 2021 will be recruited Patients who accept to participate in the study will be classified into three risk groups low-risk moderate-risk and high risk based on medical history Mean Arterial Pressure MAP Pregnancy-Associated Plasma Protein A PAPP-A and Uterine Artery Pulsatility Index UTPI Placental Growth Factor PlGF will only be determined in those patients classified as intermediate risk after this first step and then reclassified in high and low-risk patients depending on its values The number of first-trimester scans performed by these hospitals is approximately 8200 patients annually Due to PE prevalence in our environment is around 3 of the total population a total of 246 cases of PE are to be expected Therefore based on similar previous experiences we could assume that 80 of the patients will accept to participate in the study meaning a total sample of 6560 pregnant women
This is a prospective multicentre cohort study with the collaboration of Hospital de la Santa Creu i Sant Pau Barcelona Hospital Universitario de Cruces Bilbao Hospital Son Llàtzer Mallorca and Hospital Clínico Universitario Lozano Blesa Zaragoza Women with a singleton pregnancy attending to the 12-week ultrasound scan at one of the maternity hospitals participating in the study between March 1st 2021 and 30th October 2021 will be recruited Patients who accept to participate in the study will be classified into three risk groups low-risk moderate-risk and high risk based on medical history Mean Arterial Pressure MAP Pregnancy-Associated Plasma Protein A PAPP-A and Uterine Artery Pulsatility Index UTPI Placental Growth Factor PlGF will only be determined in those patients classified as intermediate risk after this first step and then reclassified in high and low-risk patients depending on its values The number of first-trimester scans performed by these hospitals is approximately 8200 patients annually Due to PE prevalence in our environment is around 3 of the total population a total of 246 cases of PE are to be expected Therefore based on similar previous experiences we could assume that 80 of the patients will accept to participate in the study meaning a total sample of 6560 pregnant women
Detailed Description:
All the data required to carry out this study including those derived from sonographies and blood tests will be collected during the normal pregnancy control without further appointments A blood test will be requested in all pregnant women in the first appointment of pregnancy control between 9 and 13 weeks to determine risk of chromosomal disorders according to the national protocol and it will be used this same sample to analyze angiogenic factors without requiring new blood extractions In the first-trimester scan the mean uterine arteries pulsatility index will be determined as well as mean arterial pressure In this visit the patient will be asked about her medical history We will offer the patients the inclusion to our study in that moment those who agree to participate in the study will sign the informed consent In the participants the initial risk of PE will be calculated using maternal medical history MAP UTPI and PAPP-A already used in aneuploidies screening using the software validated to each laboratory Patients will be classified into 3 groups
Low risk of PE 1500
Intermediate risk of PE between 150 and 1500
High risk of PE 150 In those patients classified as intermediate and high-risk PlGF and s-Flt-1 will be determined from the blood samples kept in biobanks of each hospital according to the current legislation SFlt-1 results will be analyzed at the end of the study in order to decrease the cost because there will not be used to make clinical decisions PlGF in high-risk patients will not be considered either to reclassify those patients In both cases the diagnostic efficiency will be analyzed at the end of the study
Patients in the intermediate-risk group 150-1500 will be reclassified after adding PlGF levels in the predictive algorithm in 2 groups Low risk of PE 1160 and High risk of PE 1160
To the patients classified as high risk at any of the steps will be offered prophylactic treatment with AcetylSalicylic acid ASA 150mg24h until 36 weeks of pregnancy if there is not a contraindication All data from eligible patients will be analyzed A bivariant statistical analysis will be performed in order to assess the relationship between dependent variables diagnose of PE andor IUGR and the other variables included in this study
Low risk of PE 1500
Intermediate risk of PE between 150 and 1500
High risk of PE 150 In those patients classified as intermediate and high-risk PlGF and s-Flt-1 will be determined from the blood samples kept in biobanks of each hospital according to the current legislation SFlt-1 results will be analyzed at the end of the study in order to decrease the cost because there will not be used to make clinical decisions PlGF in high-risk patients will not be considered either to reclassify those patients In both cases the diagnostic efficiency will be analyzed at the end of the study
Patients in the intermediate-risk group 150-1500 will be reclassified after adding PlGF levels in the predictive algorithm in 2 groups Low risk of PE 1160 and High risk of PE 1160
To the patients classified as high risk at any of the steps will be offered prophylactic treatment with AcetylSalicylic acid ASA 150mg24h until 36 weeks of pregnancy if there is not a contraindication All data from eligible patients will be analyzed A bivariant statistical analysis will be performed in order to assess the relationship between dependent variables diagnose of PE andor IUGR and the other variables included in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None