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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03111576
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

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.

Condition or disease

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
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03111576

Contact: Nesreen A Shehata, MD 00201024150605
Contact: Hamada A Abd el Wahed, MD 01007240754

Nesreen Abdel Fattah Abdullah Shehata Recruiting
Cairo, Egypt
Contact: Nesreen AFattah Shehata, MD    00201024150605   
Contact: Hamada Ashry Abdel wahed, MD    01007240754   
Sponsors and Collaborators
Beni-Suef University

Responsible Party: Nesreen Abdel Fattah Abdullah Shehata, Assistant professor of Obstetrics and Gynecology, Beni-Suef University Identifier: NCT03111576     History of Changes
Other Study ID Numbers: Beni-Suef 11
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications