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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

Tracking Information
First Submitted Date October 11, 2019
First Posted Date October 15, 2019
Last Update Posted Date October 15, 2019
Actual Study Start Date February 10, 2019
Estimated Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal and Neonatal Outcome in Severe Preeclampsia
Official Title Maternal and Neonatal Outcome in Severe Preeclamptic Patients
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pregnant ladies with preeclampsia
Condition Pre-Eclampsia
Intervention Diagnostic Test: Ultrasonography to assess fetus and mother
to assess fetal growth and maternal outcome
Study Groups/Cohorts Not Provided
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: October 11, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2020
Estimated Primary Completion Date January 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • • All women with severe preeclampsia

Exclusion Criteria:

  • • History of epilepsy.

    • Patients with chronic hypertension.
    • Patients with renal disease.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnant women with preeclampsia
Ages 20 Years to 42 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mahmoud Alalfy, PhD 01002611058 mahmoudalalfy@ymail.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04126122
Other Study ID Numbers Preeclampsia
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 Not Provided
Responsible Party Mahmoud Alalfy, Aljazeera Hospital
Study Sponsor Aljazeera Hospital
Collaborators Cairo University
Investigators Not Provided
PRS Account Aljazeera Hospital
Verification Date October 2019