Preeclampsia Sequential Screening Using Angiogenic Factors During First Trimester of Pregnancy

NCT04767438 | Unknown

• 1 other identifier: CRISP
• Study Type: observational
• Target: 6,560
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-Eclampsia; Pregnancy Complications

Keywords

Preeclampsia; Screening

Outcome Measures

Primary Outcomes (1)

• Diagnosis of preeclampsia

  Diagnosis of preeclampsia during pregnancy following the definition of the International Society for the Study of Hypertension in Pregnancy, (ISSHP)

  30 weeks

Secondary Outcomes (12)

• Early-onset Preeclampsia

  30 weeks

• Severe preeclampsia

  30 weeks

• Pregnancy-induced hypertension

  30 weeks

• SGA

  30 weeks

• IUGR

  30 weeks

Study Arms (1)

Pregnant women

All singleton pregnancies that present to the 12-week scan in the Obstetrics Unit of the participant hospitals. Singleton pregnancies; Gestational age less than 14 weeks, estimated according to Crown-Rump Length (CRL); Blood sample between 8 and 14 weeks of pregnancy; Patients who accept to participate in the study and sign the informed consent.

Other: Pregnant women

Interventions

Pregnant women OTHER

All pregnant women that present to the 12-week scan in the Obstetrics Unit

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every singleton pregnancy attending during the period study

You may qualify if:

• Singleton pregnancies;
• Gestational age less than 14 weeks, estimated according to Crown-Rump Length (CRL);
• Blood sample between 8 and 14 weeks of pregnancy;
• Patients who accept to participate in the study and sign the informed consent

You may not qualify if:

• Fetus with chromosomal disorders, major congenital malformations or congenital infections diagnosed in the first-trimester ultrasound;
• Multiple pregnancies;
• Non-acceptance of participation in the study.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Instituto de Salud Carlos III: collaborator

Related Publications (28)

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  PMID: 35958398 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood samples

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Daniel Oros, PhD

CONTACT

0034616612323; danoros@unizar.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fetal Medicine, Associate Professor, University of Zaragoza

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 23, 2021

Record last verified: 2021-02