Prediction of Preeclampsia and Other Pregnancy Complicati... | NCT03067298

Studies
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

NCT03067298

Sponsor

Emmanuel Bujold

Status

Completed

Last Update Posted

Mar 15, 2022Actual

Enrollment

805Actual

Phase

Not provided

Conditions

Preeclampsia
Preterm Birth
Fetal Growth Restriction
Intra Uterine Fetal Death

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Jun 2019Actual

Completion Date

Jun 2021Actual

First Submitted Date

Jan 18, 2017

First Submission Date that Met QC Criteria

Feb 23, 2017

First Posted Date

Mar 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2022

Last Update Posted Date

Mar 15, 2022Actual

Name	Class
Thermo Fisher Scientific, Inc	INDUSTRY
Laval University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

805Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Fetal growth restriction	defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.	neonatal weight at birth (on the day of birth)
Preterm birth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel Bujold, MD, MSc	CHU de Quebec	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Quebec		Québec		G1V 4G2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D047928	Premature Birth
D005317	Fetal Growth Retardation

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

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