fullPIERS Model in the Prediction of Adverse Maternal Outcomes in Preeclampsia (Aprospective)

January 2, 2026 updated by: Alaa Abdellah Mohmed, Sohag University

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

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,

Study Overview

Status

Not yet recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Obsetatric and gynacological department at Sohag universtiy hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

exclude patients who do not meet clinical or laboratory definitions of preeclampsia or related conditions.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the fullPIERS prediction model for adverse maternal outcomes using logistic regression-derived predicted probabilities
Time Frame: 1year
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
The collected data are then will be used to calculate the predicted probability of adverse outcomes using the fullPIERS logistic regression equation logit(p)=2.68+(-5.41×10-2×gestational age) +1.23×(chest pain or dyspnea)+(-2.71×10 -2×creatinine) .
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 13, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-25-10--12Ms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

1year

IPD Sharing Access Criteria

http:// uptodate. com

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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