Vascular Changes in Pre-Eclamptic Patients and Its Impact on Pregnancy Outcome.

Pre-Eclampsia Clinical Trial

— PE  

Official title:

Assessment ofMaternal and FetalVascular Changes inNormotensive andPre-Eclamptic Patients and Its Impact on Pregnancy Outcome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03111576
• Other study ID #: Beni-Suef 11
• Status: Recruiting
• Start date: May 31, 2017
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: Beni-Suef University
• Contact: Nesreen A Shehata, MD
• Phone: 00201024150605
• Email: nesoomar[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. All women will be :

• Nonsmokers,

• Nondiabetic,

• With no family history of vascular diseases.

2. Gestational age at enrolment >28 and <34 weeks of gestation.

3. Singleton pregnancy.

4. Informed consent.

5. 50 Normotensive pregnant women without complications will be defined as controls.

6. 50 Pre-eclamptic patients.

Exclusion Criteria:

• 1. Patients who presented to labor and delivery were excluded as subjects. 2. Growth-restricted fetus due to:

• marginal insertion of the umbilical cord,

• placental infarction,

• fetal minor heart anomaly,

• Fetal viral infection. 3. Refusal of patient to participate in the study. 4. Multiple gestations. 5. Autoimmune diseases 6. Previous history of PE or IUGR.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
Egypt	Nesreen Abdel Fattah Abdullah Shehata	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular changes by Doppler imaging	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.	>28-<34 weeks
Secondary	Pregnancy outcome	Maternal delivery mode and any complications together with fetal growth restriction or neonatal complications.	Date of delivery and within 40 days after delivery