Improved Characterisation of Eclampsia

NCT05199558 | Unknown

• 1 other identifier: Prediction of Eclampsia
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Eclampsia Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Numbers of clinical features ( symptoms and signs) of eclampsia that can make a predictive model for eclampsia.

  estimate the presence or absence of a clinical signature of imminent eclampsia

  2 years

Study Arms (3)

eclamptic patients

preeclamptic patients

healthy pregnant women of same gestation and parity

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: pregnant women with preeclampsia\\eclampsia.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with preeclampsia and eclampsia who will be admitted to Women Health Hospital , Assiut University compared to healthy normotensive pregnant woman recruited from women seeking maternity services during the same or similar period at same gestational age and parity .

You may qualify if:

• Eclampsia:
• Diagnosed as new onset generalized tonic colonic seizures or coma in pregnant women or women who have recently given birth.
• Singleton pregnancies.
• All gestational ages, including post-partum eclampsia
• Enrolment to the study must occur within 7 days of an eclamptic episode Women must be coherent and able to provide informed consent prior to enrolment
• Preeclampsia:
• ● Diagnosed as new onset of hypertension (\>140 mmHg systolic or \> 90 mmHg diastolic) after the 20th week of gestation and the coexistence of one or more of the following new onset conditions:Proteinuria ,Other maternal organ evolvement.
• Singleton pregnancy.
• Have not experience an eclamptic episode
• Normotensive controls:
• Healthy normotensive pregnant woman recruited from women seeking maternity services during the same or similar period
• Matched 1:1 for each eclampsia and preeclampsia case
• Matched by closest gestational age at recruitment to cases and parity

You may not qualify if:

• Women with multiple pregnancies.
• Women with seizures attributed to a diagnosis other than eclampsia such as; central nervous system infections, a history of seizures or epilepsy, medications and/or illicit drug use.
• Women unable to provide informed consent

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Osungbade KO, Ige OK. Public health perspectives of preeclampsia in developing countries: implication for health system strengthening. J Pregnancy. 2011;2011:481095. doi: 10.1155/2011/481095. Epub 2011 Apr 4.

  PMID: 21547090 BACKGROUND

• Frias AE Jr, Belfort MA. Post Magpie: how should we be managing severe preeclampsia? Curr Opin Obstet Gynecol. 2003 Dec;15(6):489-95. doi: 10.1097/00001703-200312000-00006.

  PMID: 14624215 BACKGROUND

Central Study Contacts

Yousra M. Othman

CONTACT

+201064990954; yousramo5tar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator , assistant lecturer of obstetrics and gynecology, Assiut University, Egypt

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 20, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 16, 2022

Record last verified: 2021-12