Preterm Birth Clinical Trial
Official title:
Pré-Eclampsie et Retard de Croissance: Une étude Longitudinale Évaluative (PERLE)
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).
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Completed |
NCT02993744 -
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
|
N/A | |
Active, not recruiting |
NCT02673216 -
Infection and Adverse Pregnancy Outcome
|
||
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Completed |
NCT01412931 -
Protein and Ultrasound Indicators of Preterm Birth
|
N/A | |
Completed |
NCT02606058 -
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
|
N/A | |
Terminated |
NCT03715530 -
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
|
N/A | |
Completed |
NCT00422526 -
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
|
Phase 3 | |
Enrolling by invitation |
NCT04251260 -
Effectiveness of Positioning in Preterm Neonates
|
N/A | |
Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 | |
Recruiting |
NCT03638037 -
Correlation Between Maternal Vitamin D Level And Preterm Birth
|
||
Completed |
NCT02225353 -
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
|
Phase 2 | |
Recruiting |
NCT03992534 -
The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth
|
Phase 1 | |
Completed |
NCT03144141 -
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
|
N/A | |
Completed |
NCT05210985 -
Examination of the Relationship Between Home Affordances With Development
|
||
Completed |
NCT04811742 -
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
|
N/A |