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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 : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Tracking Information
First Submitted Date April 7, 2017
First Posted Date April 13, 2017
Last Update Posted Date November 22, 2018
Actual Study Start Date May 31, 2017
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03111576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 7, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vascular Changes in Pre-Eclamptic Patients and Its Impact on Pregnancy Outcome.
Official Title Assessment ofMaternal and FetalVascular Changes inNormotensive andPre-Eclamptic Patients and Its Impact on Pregnancy Outcome.
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).

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pre-Eclampsia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 7, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nesreen A Shehata, MD 00201024150605 nesoomar@yahoo.com
Contact: Hamada A Abd el Wahed, MD 01007240754 hamadaashry2010@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03111576
Other Study ID Numbers Beni-Suef 11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
Study Sponsor Beni-Suef University
Collaborators Not Provided
Investigators Not Provided
PRS Account Beni-Suef University
Verification Date November 2018