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

NCT ID: NCT03111576

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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).

Conditions

Pre-Eclampsia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Normotensive

This group will include 50 pregnant women with normal blood pressure between 28 and 34 weeks.

No interventions assigned to this group

Pre-eclamptic

This group will include 50 pregnant women with diagnosis of pre-eclampsia between 28 and 34 weeks.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Nesreen Abdel Fattah Abdullah Shehata

Assistant professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nesreen Abdel Fattah Abdullah Shehata

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nesreen A Shehata, MD

Role: CONTACT

nesoomar@yahoo.com

00201024150605

Hamada A Abd el Wahed, MD

Role: CONTACT

hamadaashry2010@yahoo.com

01007240754

Facility Contacts

Nesreen AFattah Shehata, MD

Role: primary

nesoomar@yahoo.com

00201024150605

Hamada Ashry Abdel wahed, MD

Role: backup

Hamadaashry2010@yahool.com

01007240754

Other Identifiers

Beni-Suef 11

Identifier Type: -

Identifier Source: org_study_id