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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia

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).

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Nesreen A Shehata, MD; Phone Number: 00201024150605; Email: nesoomar@yahoo.com
• Study Contact Backup: Name: Hamada A Abd el Wahed, MD; Phone Number: 01007240754; Email: hamadaashry2010@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Nesreen Abdel Fattah Abdullah Shehata
    • Contact: Nesreen AFattah Shehata, MD; Phone Number: 00201024150605; Email: nesoomar@yahoo.com
    • Contact: Hamada Ashry Abdel wahed, MD; Phone Number: 01007240754; Email: Hamadaashry2010@yahool.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

on 50 normotensive pregnant women and 50 Pre-eclamptic patients will attend the antenatal clinic in the obstetric ward in the department of Obstetrics and Gynecology in Benisuef general hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Normotensive; This group will include 50 pregnant women with normal blood pressure between 28 and 34 weeks.
Pre-eclamptic; This group will include 50 pregnant women with diagnosis of pre-eclampsia between 28 and 34 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: Beni-Suef 11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No