Pre-Eclampsia And Growth Restriction: a Longitudinal Study

Preterm Birth Clinical Trial

— PEARL  

Official title:

Pré-Eclampsie et Retard de Croissance: Une étude Longitudinale Évaluative (PERLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379832
• Other study ID #: B14-07-2037
• Secondary ID: B14-07-2037
• Status: Completed
• Start date: March 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Preeclampsia may have several causes leading to different characteristics of the pathology. Differentiation between the "type of preeclampsia" would help to treat patients more accurately. This project aims to identify early markers that are specific to each type of preeclampsia (early or late, with or without growth restriction). Through a case-control study, many data will be collected prospectively (serum markers, ultrasonographic markers, maternal factors) among nulliparous women with no sign of preeclampsia (as soon as the first trimester) and nulliparous women with preeclampsia (at diagnosis).

Description:

Background: The current definition of preeclampsia is based on signs and symptoms without reference to the pathology. The majority of preeclampsia cases would come from placental dysfunction beginning early in pregnancy, even before the onset of clinical or biochemical events leading to the diagnosis. Defects in the development of the placenta (impaired transformation of the spiral arteries) would seem to lead to poor placental perfusion. Currently, the uterine artery Doppler is the marker used to predict placental perfusion in routine monitoring of the pregnant woman. However, other placental aspects, such as the ultrasonographic measurement of placental volume could also be useful for predicting preeclampsia. Also, several studies have shown that many blood markers (PAPP-A, PlGF, sFlt-1) detected as soon as the first trimester seem effective to predict the majority of early pre-eclampsia, those occurring before 34 weeks of gestation. However, the predictive value of these markers is not so strong regarding prediction of later preeclampsia, those occurring between 34-37 weeks and at term.

Other studies show that some maternal factors, including the value of arterial pressure, BMI, maternal age, could contribute to screening for pre-eclampsia. Recent studies have also been interested in the maternal ophthalmic artery Doppler to try to predict preeclampsia even before the development of clinical symptoms.

Our hypothesis is that each of these biomarkers may be specific to a certain type of pre-eclampsia (early or late; with or without intra uterine growth restriction). We believe that actual definition of preeclampsia includes heterogenous causes and that better understanding of this pathology would help practicians to offer a more individualised treatment to their patients.

Objective: Our main goal is to characterize from a biophysical, biochemical, ultrasonographic and placental perspective the pathology of preeclampsia.

Method: This case-control study will recruit:

1. nulliparous women at 1st trimester of pregnancy. They will provide blood sample and U/S examination at 4 different times during pregnancy.

2. nulliparous women at diagnosis of preeclampsia.

Data that will be collected are:

maternal age maternal BMI maternal ethnicity maternal mean arterial pressure (at recruitment/diagnosis and delivery) gestational age at recruitment/diagnosis and at delivery maternal serum PAPP-A, PlGF, endoglin, sFlt-1 (at recruitment and delivery) cord blood PlGf, endoglin, sFlt-1 fetal crown-rump length at 1st trimester (at recruitment) fetal growth (during pregnancy) Uterine arteries Doppler Cord arteries Doppler Maternal Ophthalmic arteries Doppler Placental volume newborn birthweight

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Nulliparous women (no previous delivery = 20 weeks)

• Expect to deliver in recruiting center

• Control group: recruited between 11 - 13 6/7 weeks of gestation

• Case group: recruited at time of diagnosis of preeclampsia > 20 weeks of gestation

Exclusion Criteria:

• multiple pregnancy

• pregnant women <18 years old at recruitment

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation
• Pre-Eclampsia
• Preeclampsia
• Premature Birth
• Preterm Birth
• Severe Preeclampsia

Locations

Country	Name	City	State
Canada	CHU de Québec	Québec

Sponsors (3)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Chaire Jeanne-et-Jean-Louis Lévesque en périnatalogie, Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fetal growth restriction	Fetal growth restriction will be defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.	between 20 and 42 weeks of gestation