Eclampsia PreeclampsiaNCT05199558
Improved Characterisation of Eclampsia
An observational study of Eclampsia Preeclampsia, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eclampsia Preeclampsia
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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 .
Who may be able to join
- 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:
Show all 13Show fewer
- ● 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Improved Characterisation of Eclampsia to Optimise Maternal and Perinatal Outcomes:A Prospective Observational Multicentric Study.
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 .
Read the 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.
- Conditions
- Eclampsia Preeclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| eclamptic patients | Not described | |
| preeclamptic patients | Not described | |
| healthy pregnant women of same gestation and parity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study startMar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eclampsia PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra M. Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199558
- Sponsor's protocol ID
- Prediction of Eclampsia
- Status last verified
- Dec 2021
- First submitted
- 31 Dec 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21547090Frias 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.
PubMed 14624215
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Characterisation of Eclampsia to Optimise Maternal and Perinatal Outcomes:A Prospective Observational Multicentric Study.
- ClinicalTrials.gov ID
- NCT05199558
- Acronym / sponsor ID
- Prediction of Eclampsia
- Conditions
- Eclampsia Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eclamptic patients | – | – |
| preeclamptic patients | – | – |
| healthy pregnant women of same gestation and parity | – | – |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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 .
Key inclusion criteria (13 listed)
- Eclampsia:
- 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.
- Normotensive controls:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numbers of clinical features ( symptoms and signs) of eclampsia that can make a predictive model for eclampsia.
Time frame: 2 years
estimate the presence or absence of a clinical signature of imminent eclampsia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 21547090Osungbade 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.
- Background: PubMed 14624215Frias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Eclampsia Preeclampsia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousra M. Othman (+201064990954, yousramo5tar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of clinical features ( symptoms and signs) of eclampsia that can make a predictive model for eclampsia. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199558, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.