Factors Predicting Transformation of Non Severe Pre-eclampsia Into Pre-eclampsia With Severe Features
1 other identifier
observational
1
1 country
1
Brief Summary
Preeclampsia is a multi-system progressive disorder characterized by the new onset of hypertension and proteinuria, or hypertension and significant end-organ dysfunction with or without proteinuria, in the last half of pregnancy or postpartum. The genesis of the disease is laid down in early pregnancy and is characterized anatomically by abnormal remodeling of the maternal spiral arteries at the placental site.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedDecember 29, 2021
December 1, 2021
10 months
November 29, 2021
December 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
severe pre-eclampsia
predicting transformation of non-severe pre-eclampsia in to pre-eclampsia with severe features
4 months
Study Arms (1)
Group A
Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features
Interventions
Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features.
Eligibility Criteria
Cases diagnosed as Non-severe pre-eclampsia after exclusion of severity features
You may qualify if:
- Gestational age above 20 weeks of gestation.
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg.
- Symptoms of central nervous system dysfunction of new onset such as Photopsia, scotomata, cortical blindness, retinal vasospasm, and severe headache.
- Hepatic abnormality: Severe persistent right upper quadrant or Epigastric pain or serum transaminase concentration ≥2 times the upper limit of the normal range, or both.
- Thrombocytopenia: \< 100,000 platelets/µL.
- Pulmonary edema.
You may not qualify if:
- Vesicular mole (complete or incomplete).
- Any cause of Albuminuria rather than PET such as (chronic kidney disease, type1 Diabetes mellitus.)
- Any liver disease (Acute liver diseases cause increased liver transaminases and chronic liver diseases cause decreased production of albumin and transaminases.)
- Any autoimmune disease that affects blood vessels or PLT count such as (ITP, TTP, SLE and rheumatoid arthritis.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Maternity Hospital
Cairo, 11865, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed Samy, MD
Ain Shams Maternity Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 10, 2021
Study Start
May 1, 2021
Primary Completion
March 1, 2022
Study Completion
March 30, 2022
Last Updated
December 29, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share