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

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ClinicalTrials.gov Identifier: NCT02379832
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Chaire Jeanne-et-Jean-Louis Lévesque en périnatalogie
Laval University
Information provided by (Responsible Party):
Emmanuel Bujold, CHU de Quebec-Universite Laval

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
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:

  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


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Study Type : Observational [Patient Registry]
Actual Enrollment : 76 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 8 Months
Official Title: Pré-Eclampsie et Retard de Croissance: Une étude Longitudinale Évaluative (PERLE)
Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. early onset preeclampsia [ Time Frame: 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 :
  1. Fetal growth restriction [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Maternal serum Cord blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nulliparous pregnant women
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379832


Locations
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Canada
CHU de Québec
Québec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Chaire Jeanne-et-Jean-Louis Lévesque en périnatalogie
Laval University
Investigators
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Principal Investigator: Emmanuel Bujold, MD, MSc CHU de Québec

Additional Information:

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Responsible Party: Emmanuel Bujold, Principal Investigator, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02379832     History of Changes
Other Study ID Numbers: B14-07-2037
B14-07-2037 ( Other Identifier: CER-CHU de Quebec )
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Emmanuel Bujold, CHU de Quebec-Universite Laval:
preeclampsia
preterm birth
pregnancy
placenta
intra-uterine growth restriction
fetal growth restriction
ultrasound
doppler
biomarkers
serum
PAPP-A
PlGF
sFlt-1
endoglin
Additional relevant MeSH terms:
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Premature Birth
Pre-Eclampsia
Fetal Growth Retardation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hypertension, Pregnancy-Induced
Fetal Diseases
Growth Disorders
Pathologic Processes