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NCT04126122 Clinical Trial

Maternal and Neonatal Outcome in Severe Preeclampsia

Pre-Eclampsia Clinical Trial

Official title:
Maternal and Neonatal Outcome in Severe Preeclamptic Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04126122
Other study ID # Preeclampsia
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 10, 2019
Est. completion date February 1, 2020

Study information
Verified date October 2019
Source Aljazeera Hospital
Contact Mahmoud Alalfy, PhD
Phone 01002611058
Email mahmoudalalfy@ymail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 1, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 42 Years
Eligibility Inclusion Criteria:

- • All women with severe preeclampsia

Exclusion Criteria:

- • History of epilepsy.

- Patients with chronic hypertension.

- Patients with renal disease.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Aljazeera( Al Gazeera) hospital Giza

Sponsors (2)
Lead Sponsor Collaborator
Aljazeera Hospital Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of women who will develop adverse outcome The women with preeclampsia who will develop eclampsia or pulmonaryb edema within 5 months
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