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

NCT07125599 | Completed DMC

• 2 other identifiers: 366Cairo university
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Preeclampsia

Keywords

preeclampsia; complications

Outcome Measures

Primary Outcomes (1)

• Number of participants developed eclampsia

  convulsions in women with severe preeclampsia

  3 days after delivery

Eligibility Criteria

• Gender Eligibility Details: pregnant women with severe preeclampsia
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All suffering of sever preeclampsia that characterized with one or two of the following:( Dennis A. T etal2012) 1. Blood pressure of 160/110 or more. 2. Thrombocytopenia (platelet count less than 100,0000 / microliter). 3. Impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration). 4. Severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnosis, or both. 5. The new development of renal insufficiency (elevated serum creatinine\> 1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease)

You may qualify if:

• Maternal age from 18 to 40 years.
• Gestational age (28\_38) weeks, confirmed by the first day of the last menstrual period or first trimesteric ultrasound
• All suffering of severe preeclampsia

You may not qualify if:

• known liver disease
• Maternal medical disorders rather than hypertension.
• Rupture of membrane.
• Renal disorder.
• History of illicit drug use.
• Fetal congenital anomalies.
• The maternal administration of respiratory depressants within 2 hours from the delivery of the fetus (e. g., opioid analgesic )
• Associated inflammatory disease or sepsis.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Cairo Governorate, 12111, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed Maged, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: May 2, 2020
• Primary Completion: April 30, 2025
• Study Completion: May 20, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)