Viewing Study NCT05199558


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Study NCT ID: NCT05199558
Status: UNKNOWN
Last Update Posted: 2022-02-16
First Post: 2021-12-31
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Improved Characterisation of Eclampsia
Sponsor: Assiut University
Organization:

Study Overview

Official Title: Improved Characterisation of Eclampsia to Optimise Maternal and Perinatal Outcomes:A Prospective Observational Multicentric Study.
Status: UNKNOWN
Status Verified Date: 2021-12
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Eclampsia is a serious pregnancy complication.In our study we aim to characterize the clinical signs and symptoms that occur prior to the onset of eclampsia in a prospectively collected cohort.And Compare these characteristics to women with preeclampsia and healthy normal pregnancies to identify which features represent a unique clinical signature for eclampsia to form a simple predictive algorithm .
Detailed Description: Eclampsia is a serious pregnancy complication that occurs when a pregnant woman - or new mother - experiences seizures associated with hypertension. These seizures pose a major risk to the life and the health of mothers and unborn babies. Signs or symptoms of severe preeclampsia are not always present or easy to recognise before a woman develops eclampsia. This is why it can be difficult to tell which women are likely to develop eclampsia before the first seizure occurs. If we can identify the features that are most common and unique to eclampsia, these could be used to develop a tool to help identify the women displaying signs or symptoms that occur prior to the onset of eclamptic seizures. This would mean that treatment to prevent seizures could be targeted to the right women and quickly administered before they become extremely unwell with this life-threatening complication.

Rates of eclampsia are far greater in low to middle income countries , with an estimated 16-69 cases of eclampsia per 10,000 livebirths. Thus, research conducted in LMIC settings allow for the prospective recruitment of a relatively large cohort of women with eclampsia. They are a useful target population to prospectively characterise the signs and symptoms preceding the disease. Such characterisation may yield a unique clinical signature for eclampsia and the development of a predictive algorithm.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: