Vascular Changes in Pre-Eclamptic Patients and Its Impact on Pregnancy Outcome. (PE)
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|ClinicalTrials.gov Identifier: NCT03111576|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : January 25, 2018
Normal pregnancy is associated with vasodilation and decreased peripheral resistance, which is detected as early as 5 weeks' gestation .
Pre-eclampsia is a multi-system disorder of the second half of pregnancy , which is characterized by increased vascular reactivity and peripheral resistance with pathological changes that are consistent with impaired blood flow to the affected vascular beds. Investigators will evaluate fetal and maternal vascular changes in normotensive and pre-eclamptic patients by Ultrasound and Doppler and their impact on prediction of pregnancy outcome.
|Condition or disease|
Pre-eclampsia affects 2-8% of all pregnancies, although treatment is generally effective. However, 10-15% of direct maternal deaths are associated with Pre-eclampsia and eclampsia(WHO, 2011). There is a considerable evidence that generalized endothelial dysfunction underlies the clinical manifestations of the disease (Oladipupo et al., 2014).
It has been demonstrated that peripheral nutritive blood flow is impaired in pregnancies complicated by pre-eclampsia and precedes onset of the disorder (Kenny et al., 2014).
The pathophysiological mechanism is characterized by a failure of the trophoblastic invasion of the spiral arteries which may be associated with an increased vascular resistance of the uterine artery and a decreased perfusion of placenta. (Al-Jameil et al ; 2014 ) Ultrasound of the brachial artery, and Doppler ultrasound of the carotid artery and uterine artery are propaedeutic , non-invasive methods that contribute to the understanding of the pathophysiology of PE and Eclampsia (Takata et al., 2002 ).
Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of preeclampsia, intrauterine growth restriction and perinatal death. Assessment of the fetal circulation is essential in the better understanding of the pathophysiology of a wide range of pathological pregnancies and their clinical management(Ghidini & Vergani, 2012).
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Assessment ofMaternal and FetalVascular Changes inNormotensive andPre-Eclamptic Patients and Its Impact on Pregnancy Outcome.|
|Actual Study Start Date :||May 31, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
This group will include 50 pregnant women with normal blood pressure between 28 and 34 weeks.
This group will include 50 pregnant women with diagnosis of pre-eclampsia between 28 and 34 weeks.
- Vascular changes by Doppler imaging [ Time Frame: >28-<34 weeks ]Doppler imaging will be undertaken for assessing fetal umbilical, middle cerebral arteries in addition to ductus venosus. Concerning maternal vessel assessment, Doppler will be done for uterine arteries, common carotid and brachial arteries.
- Pregnancy outcome [ Time Frame: Date of delivery and within 40 days after delivery ]Maternal delivery mode and any complications together with fetal growth restriction or neonatal complications.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111576
|Contact: Nesreen A Shehata, MDfirstname.lastname@example.org|
|Contact: Hamada A Abd el Wahed, MDemail@example.com|
|Nesreen Abdel Fattah Abdullah Shehata||Recruiting|
|Contact: Nesreen AFattah Shehata, MD 00201024150605 firstname.lastname@example.org|
|Contact: Hamada Ashry Abdel wahed, MD 01007240754 Hamadaashry2010@yahool.com|