Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

Completed

• Conditions: Fetal Growth Restriction; Intra Uterine Fetal Death; Preeclampsia; Preterm Birth

• Registration Number: NCT03067298
• Lead Sponsor: Emmanuel Bujold

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.

Detailed Description

The objective of this study is to validate the predictive values of biophysical (maternal blood pressure); biochemical (sFlt-1, β-hCG, PlGF, and AFP) and ultrasonographic (cervical length, Doppler, 3D evaluation of the placenta, 3D nasal bone) biomarkers at several timepoints for the prediction of adverse pregnancy outcomes including preterm birth, preeclampsia, fetal growth restriction and intra-uterine fetal death.

These biomarkers will be evaluated at 14-16 weeks, 20-24 weeks and 30-34 weeks. Those specific gestational ages have been selected because they correspond to the typical clinical/hospital visits for prenatal blood and/or ultrasound screening.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-03-01
• Primary Completion: 2019-06
• Study Completion: 2021-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 805

Inclusion Criteria

• nulliparous pregnant women participating in Prediction study (NCT02189148)

Exclusion Criteria

• <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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
preeclampsia	>20 weeks of 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

Secondary Outcome Measures

Name	Time	Method
Fetal growth restriction	neonatal weight at birth (on the day of birth)	defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.
Preterm birth	between 20-37 weeks of gestation	defined as delivery \<37 weeks of gestation.
Intra uterine fetal death	from the 20th week of gestation to the moment of birth	fetal death during pregnancy

Trial Locations

Locations (1)

CHU de Quebec; 🇨🇦 Quebec, Canada