First-trimester Prediction of Preeclampsia

NCT02189148 | Completed

• 2 other identifiers: CIHR-MOP-133672B14-05-2024
• Study Type: observational
• Target: 7,554
• Locations: 1 country
• Sites: 4

Brief Summary

Preeclampsia is a complication of pregnancy related to adverse maternal and neonatal outcomes, including fetal growth restriction and perinatal death. Several measures are used or under investigation (low-dose aspirin, low-molecular weight heparin, calcium, folic acid, among others) for the prevention of preeclampsia. Unfortunately, most high-risk women who could benefit from those preventive measures are not identified until late in pregnancy. Recent evidences suggest that the investigators could identify women at risk of developing preeclampsia using a combination of serum and ultrasound biomarkers in the first-trimester of pregnancy. This screening test needs external validation. A first-trimester screening strategy will strengthen clinical research on preeclampsia and will contribute to the development of strategy combining the prediction and prevention of the disease and its related complications.

Conditions

Preeclampsia; Severe Preeclampsia; Fetal Growth Restriction; Preterm Birth

Keywords

Prediction; Preeclampsia; Preterm birth; Pregnancy; Placenta; Intra-uterine growth restriction; fetal growth restriction; Ultrasound; Doppler; Biomarkers; PAPP-A; Placental growth factor (PlGF)

Outcome Measures

Primary Outcomes (1)

• early onset preeclampsia

  Preeclampsia will be defined according to the Canadian Guidelines for Diagnosis, Evaluation, and Management of the Hypertensive Disorders of Pregnancy guidelines, as de novo hypertension with diastolic blood pressure \>90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions

  diagnosed between 20 and 34 weeks of gestation

Secondary Outcomes (2)

• Severe preeclampsia

  between 20 and 42 weeks of gestation

• Fetal growth restriction

  between 20 and 42 weeks of gestation

Study Arms (1)

Cohort

Each participant will : * give consent * provide a blood sample (10 ml) * be measured (weight and height for BMI calculation) * undergo a blood pressure measurement * have an ultrasound exam (uterine arteries Doppler, placental volume, thickness of the placenta) * answer to a short questionnaire (5 pages)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nulliparous women who will deliver in one of the participating center: CHUL Hospital, Quebec city, QC Hôpital Saint-François-d'Assise, Quebec city, QC CHU Ste-Justine, Montreal, QC Southern Alberta Maternal Fetal Medicine Centre, Calgary, Alberta Sinai Health System, Mount Sinai Hospital, Toronto, Ontario

You may qualify if:

• gestational age between 11 3/7 and 13 6/7 weeks;
• nulliparous women (no previous delivery ≥ 20 weeks).

You may not qualify if:

• pregnant women \<18 years old at recruitment;
• multiple pregnancies;
• fetal congenital malformation;
• positive for HIV or hepatitis C or hepatitis B;
• negative fetal heart at recruitment;
• women planning a delivery outside the participating hospitals;
• women not able to provide an informed consent to the study.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Laval University: collaborator

Study Sites (4)

South Alberta Maternal Fetal Medicine Centre, University of Calgary

Calgary, Alberta, Canada

Location

Sinai Health System, Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

CHU Ste-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

CHU de Québec

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

• Guerby P, Audibert F, Johnson JA, Okun N, Giguere Y, Forest JC, Chaillet N, Masse B, Wright D, Ghesquiere L, Bujold E. Prospective Validation of First-Trimester Screening for Preterm Preeclampsia in Nulliparous Women (PREDICTION Study). Hypertension. 2024 Jul;81(7):1574-1582. doi: 10.1161/HYPERTENSIONAHA.123.22584. Epub 2024 May 6.

  PMID: 38708601 DERIVED

Related Links

• Prediction study at Centre de recherche du Centre Hospitalier Universitaire de Québec

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal serum

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Premature Birth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Emmanuel Bujold, MD, MSc

  CHU de Québec

  PRINCIPAL INVESTIGATOR

• François Audibert, MD, MSc

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 23, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)