fullPIERS Model in the Prediction of Adverse Maternal Out... | NCT07316140

Studies
fullPIERS Model in the Prediction of Adverse Maternal Outcomes in Preeclampsia

NCT07316140

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Preeclampsia
Fullpairs

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Dec 13, 2025

First Submission Date that Met QC Criteria

Jan 2, 2026

First Posted Date

Jan 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2026

Last Update Posted Date

Jan 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female Patients diagnosed with preeclampsia

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Obsetatric and gynacological department at Sohag universtiy hospital		Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Statistical Analysis Plan (SAP)

Time Frame

1year

Access Criteria

http:// uptodate. com

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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