The Association Between Different Markers With Development of Maternal and Neonatal Complications in Women With Severe Preeclampsia

NCT ID: NCT07125599

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 284 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2025-05-20

Brief Summary

pregnant women diagnosed with severe preeclampsia were subjected to • Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not).gravidity , parity mode of delivery any medical disorders, the presence of headache ,blurring of vision and epigastric pain.

• Complete physical examination: general (including BMI & blood pressure measurement) and obstetric examinations.
• Routine obstetric ultrasound and Doppler indices Including umbilical artery Doppler (RI).
• Laboratory investigations :

1. Complete blood count (CBC). 2 albuminuria will be detected by dipstick kits . 3. Liver enzymes & kidney function. 4.PT,PC,INR.

• Pelvic-Abdominal ultrasound to assess the presence of ascites Ultrasound examination will be performed by a consultant obstetrician to detect free fluid in the peritoneal cavity, especially at hepato-renal pouch, sub-splenic area, or para-colic gutters.

The presence of ascites will be further confirmed at the time of delivery.

3-All labours will be attended by an expert neonatologist and the following will be recorded:

• APGAR score at (1 min).
• The further need for neonatal intensive care unit (NICU) admission.
• Perinatal death

Detailed Description

pregnant women diagnosed with severe preeclampsia were subjected to • Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not).gravidity , parity mode of delivery any medical disorders, the presence of headache ,blurring of vision and epigastric pain.

• Complete physical examination: general (including BMI & blood pressure measurement) and obstetric examinations.
• Routine obstetric ultrasound and Doppler indices Including umbilical artery Doppler (RI).
• Laboratory investigations :

1. Complete blood count (CBC). 2 albuminuria will be detected by dipstick kits . 3. Liver enzymes & kidney function. 4.PT,PC,INR.

• Pelvic-Abdominal ultrasound to assess the presence of ascites Ultrasound examination will be performed by a consultant obstetrician to detect free fluid in the peritoneal cavity, especially at hepato-renal pouch, sub-splenic area, or para-colic gutters.

The presence of ascites will be further confirmed at the time of delivery.

3-All labours will be attended by an expert neonatologist and the following will be recorded:

• APGAR score at (1 min).
• The further need for neonatal intensive care unit (NICU) admission.
• Perinatal death

Conditions

Severe Preeclampsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Maternal age from 18 to 40 years.

2. Gestational age (28_38) weeks, confirmed by the first day of the last menstrual period or first trimesteric ultrasound

3. All suffering of severe preeclampsia

Exclusion Criteria

1. known liver disease

2. Maternal medical disorders rather than hypertension.

3. Rupture of membrane.

4. Renal disorder.

5. History of illicit drug use.

6. Fetal congenital anomalies.

7. The maternal administration of respiratory depressants within 2 hours from the delivery of the fetus (e. g., opioid analgesic )

8. Associated inflammatory disease or sepsis.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo university

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Cairo university

Identifier Type: OTHER

Identifier Source: secondary_id

366

Identifier Type: -

Identifier Source: org_study_id