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Maternal and Neonatal Outcome in Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT04126122
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Mahmoud Alalfy, Aljazeera Hospital

Brief Summary:
In normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue

Condition or disease Intervention/treatment
Pre-Eclampsia Diagnostic Test: Ultrasonography to assess fetus and mother

Detailed Description:

Preeclampsia is considered severe if one or more of the following:

  1. Blood pressure of 160mmHg systolic or high or 110mmHg diastolic or high on two occasions at least 6 hours a part while the patient on bed rest.
  2. Proteinuria of 0.3gm. or high in 24 hours urine specimen or +1 or great on two random urine samples collected at least 4 hours apart.
  3. Oliguria of less than 500ml in 24 hours.
  4. Cerebral or visual disturbance.
  5. Pulmonary edema or cyanosis.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal and Neonatal Outcome in Severe Preeclamptic Patients
Actual Study Start Date : February 10, 2019
Estimated Primary Completion Date : January 10, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Ultrasonography to assess fetus and mother
    to assess fetal growth and maternal outcome


Primary Outcome Measures :
  1. The number of women who will develop adverse outcome [ Time Frame: within 5 months ]
    The women with preeclampsia who will develop eclampsia or pulmonaryb edema



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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women with preeclampsia
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pregnant ladies with preeclampsia
Criteria

Inclusion Criteria:

  • • All women with severe preeclampsia

Exclusion Criteria:

  • • History of epilepsy.

    • Patients with chronic hypertension.
    • Patients with renal disease.

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 ClinicalTrials.gov identifier (NCT number): NCT04126122


Contacts
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Contact: Mahmoud Alalfy, PhD 01002611058 mahmoudalalfy@ymail.com

Locations
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Egypt
Aljazeera( Al Gazeera) hospital Recruiting
Giza, Egypt
Contact: Mahmoud Alalfy, PhD    +201002611058 ext +2    mahmoudalalfy@ymail.com   
Sponsors and Collaborators
Aljazeera Hospital
Cairo University

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Responsible Party: Mahmoud Alalfy, Researcher , lecturer ,Obstetrics and Gynecology , National Research Centre, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT04126122     History of Changes
Other Study ID Numbers: Preeclampsia
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications