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Not yet recruiting NCT07316140

fullPIERS Model in the Prediction of Adverse Maternal Outcomes in Preeclampsia

Observational Preeclampsia Fullpairs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Preeclampsia, Fullpairs. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Study of Validation of the fullPIERS Model in the Prediction of Adverse Maternal Outcomes in Women With Pre- Eclampsia in Sohag University Hospital

Overview

Apredictive formula, fullPIERS (Pre-eclampsia Integrated Estimate of Risk Score), can be used to estimate the risk of suffering an adverse outcome using information obtained within 48 hours of admission with pre-eclampsia. The following information is used, serum creatinine, gestational age, platelet count,

Detailed description

Inclusion criteria Patients diagnosed with preeclampsia, defined by hypertension (systolic BP

≥140 mmHg and/or diastolic BP ≥90 mmHg, measured twice more than 4 hours apart after 20 weeks gestation) Proteinuria of at least 0.3 g/dl or ≥300 mg of protein in a 24-hour urine collection Urine albumin-creatinine ratio (ACR) ≥30 mg/mmol, or hypertension with end organ dysfunction after20 weeks gestation

Primary outcome measures

  • Validation of the fullPIERS prediction model for adverse maternal outcomes using logistic regression-derived predicted probabilities [Time frame: 1year]
  • Evaluate the validity of the fullPIERS model in the prediction of adverse maternal outcomes in women with pre-eclampsia in Sohag Governorate, Egypt. [Time frame: 1year]

Eligibility criteria

  • Inclusion Criteria Female patients diagnosed with preeclampsia. Gestational age ≥ 20 weeks.

Hypertension defined as:

Systolic blood pressure ≥ 140 mmHg and/or Diastolic blood pressure ≥ 90 mmHg, measured on at least two occasions more than 4 hours apart.

Proteinuria defined as:

  • 300 mg protein in a 24-hour urine collection or
  • 0.3 g/dL on urine analysis. Singleton pregnancy. Exclusion Criteria Patients who do not meet the clinical or laboratory diagnostic criteria of preeclampsia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Obsetatric and gynacological department at Sohag universtiy hospital — Sohag

Identifiers

NCT: NCT07316140 · Soh-Med-25-10--12Ms

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗