PreeclampsiaAprospectiveNCT07316140
fullPIERS Model in the Prediction of Adverse Maternal Outcomes in Preeclampsia
An observational study of Preeclampsia and Fullpairs, run by Sohag University at 1 site in Egypt.
Trial 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, Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia, Fullpairs
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: exclude patients who do not meet clinical or laboratory definitions of preeclampsia or related conditions.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Obsetatric and gynacological department at Sohag universtiy hospital
Sohag
Alaa Abdellah, Master's student, +20 01000798592, elwaninyalaa@gmail.com
About this study
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
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,
Read the 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
- Conditions
- Preeclampsia, Fullpairs
- Keywords
- Fullpairs score, Fullpairs, Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the fullPIERS prediction model for adverse maternal outcomes using logistic regression-derived predicted probabilities
Measured: 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) .
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdellah Mohmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316140
- Sponsor's protocol ID
- Soh-Med-25-10--12Ms
- Acronym
- Aprospective
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07316140
- Acronym / sponsor ID
- Aprospective / Soh-Med-25-10--12Ms
- Conditions
- Preeclampsia, Fullpairs
- Keywords
- Fullpairs score, Fullpairs, Preeclampsia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- exclude patients who do not meet clinical or laboratory definitions of preeclampsia or related conditions.
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
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
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) .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Yes
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Severe Preeclampsia
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.
Obsetatric and gynacological department at Sohag universtiy hospital
Sohag, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Fullpairs, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the fullPIERS prediction model for adverse maternal outcomes using logistic regression-derived predicted probabilities (time frame: 1year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.