Maternal and Neonatal Outcome in Severe Preeclampsia

Maternal and Neonatal Outcome in Severe Preeclamptic Patients

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

Study Overview

• Status: Unknown
• Conditions: Pre-Eclampsia
• Intervention / Treatment: 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.

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

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Aljazeera( Al Gazeera) hospital
    • Contact: Mahmoud Alalfy, PhD; Phone Number: +2 +201002611058; Email: mahmoudalalfy@ymail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant ladies with preeclampsia

Description

Inclusion Criteria:

• • All women with severe preeclampsia

Exclusion Criteria:

• • History of epilepsy.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of women who will develop adverse outcome	The women with preeclampsia who will develop eclampsia or pulmonaryb edema	within 5 months

Collaborators and Investigators

• Sponsor: Aljazeera Hospital
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Anticipated): January 10, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

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

Drug and device information, study documents

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