Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

NCT03067298 | Completed

• 1 other identifier: 2017-3219
• Study Type: observational
• Target: 805
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy. Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.

Conditions

Preeclampsia; Preterm Birth; Fetal Growth Restriction; Intra Uterine Fetal Death

Keywords

pregnancy; screening; doppler; markers; PlGF; sFlt-1; placenta

Outcome Measures

Primary Outcomes (1)

• preeclampsia

  1\) de novo hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure \>90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, and 2) associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions

  >20 weeks of preeclampsia

Secondary Outcomes (3)

• Fetal growth restriction

  neonatal weight at birth (on the day of birth)

• Preterm birth

  between 20-37 weeks of gestation

• Intra uterine fetal death

  from the 20th week of gestation to the moment of birth

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

Pregnant women

You may qualify if:

• nulliparous pregnant women participating in Prediction study (NCT02189148)

You may not qualify if:

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

Sponsors & Collaborators

• Emmanuel Bujold: lead
• Thermo Fisher Scientific, Inc: collaborator
• Laval University: collaborator

Study Sites (1)

CHU de Quebec

Québec, G1V 4G2, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

maternal serum, maternal plasma (cell-free DNA), maternal urine

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

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

Study Officials

• Emmanuel Bujold, MD, MSc

  CHU de Quebec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: March 1, 2017
• Study Start: October 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)