PEARL: Pre-Eclampsia And Growth Restriction: a Longitudinal Study

Sponsor

CHU de Quebec-Universite Laval (Other)

Overall Status

Completed

CT.gov ID

NCT02379832

Collaborator

Chaire Jeanne-et-Jean-Louis Lévesque en périnatalogie (Other), Laval University (Other)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia Severe Preeclampsia Fetal Growth Restriction Preterm Birth

Detailed 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:

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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

76 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Cases Nulliparous women recruited at diagnosis of preeclampsia No intervention, only observation of biochemical and ultrasonographic markers at recruitment and at delivery N= 45
Control Nulliparous women recruited at the beginning of pregnancy. No intervention, only observation of biochemical and ultrasonographic markers at recruitment (1st trimester), 3 other times during pregnancy (2nd and 3rd trimester) and at delivery N= 45

Outcome Measures

Primary Outcome Measures

early onset preeclampsia [diagnosed between 20 and 34 weeks of gestation]
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

Secondary Outcome Measures

Fetal growth restriction [between 20 and 42 weeks of gestation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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