Severe PreeclampsiaNCT07125599
The Association Between Different Markers With Development of Maternal and Neonatal Complications in Women With Severe Preeclampsia
An observational study of Severe Preeclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
pregnant women diagnosed with severe preeclampsia were subjected to • Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not).gravidity , parity mode of delivery any medical… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Severe Preeclampsia
- How many people
- 284 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2020to 20 May 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All suffering of sever preeclampsia that characterized with one or two of the following:( Dennis A. T etal2012) 1. Blood pressure of 160/110 or more. 2. Thrombocytopenia (platelet count less than 100,0000 / microliter). 3. Impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration). 4. Severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnosis, or both. 5. The new development of renal insufficiency (elevated serum creatinine> 1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease)
Who may be able to join
- Maternal age from 18 to 40 years.
- Gestational age (28_38) weeks, confirmed by the first day of the last menstrual period or first trimesteric ultrasound
- All suffering of severe preeclampsia
Who cannot join
- known liver disease
- Maternal medical disorders rather than hypertension.
- Rupture of membrane.
- Renal disorder.
- History of illicit drug use.
- Fetal congenital anomalies.
- The maternal administration of respiratory depressants within 2 hours from the delivery of the fetus (e. g., opioid analgesic )
- Associated inflammatory disease or sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Clinical, Laboratory and Ultrasonographic Findings With Development of Maternal and Neonatal Complications in Women With Severe Preeclampsia
pregnant women diagnosed with severe preeclampsia were subjected to • Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not).gravidity , parity mode of delivery any medical disorders, the presence of headache ,blurring of vision and epigastric pain.
- Complete physical examination: general (including BMI \& blood pressure measurement) and obstetric examinations.
- Routine obstetric ultrasound and Doppler indices Including umbilical artery Doppler (RI).
- Laboratory investigations :
Read more
- Complete blood count (CBC). 2 albuminuria will be detected by dipstick kits . 3. Liver enzymes \& kidney function. 4.PT,PC,INR.
- Pelvic-Abdominal ultrasound to assess the presence of ascites Ultrasound examination will be performed by a consultant obstetrician to detect free fluid in the peritoneal cavity, especially at hepato-renal pouch, sub-splenic area, or para-colic gutters.
The presence of ascites will be further confirmed at the time of delivery.
3-All labours will be attended by an expert neonatologist and the following will be recorded:
- APGAR score at (1 min).
- The further need for neonatal intensive care unit (NICU) admission.
- Perinatal death
Read the detailed description
pregnant women diagnosed with severe preeclampsia were subjected to • Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not).gravidity , parity mode of delivery any medical disorders, the presence of headache ,blurring of vision and epigastric pain.
- Complete physical examination: general (including BMI \& blood pressure measurement) and obstetric examinations.
- Routine obstetric ultrasound and Doppler indices Including umbilical artery Doppler (RI).
- Laboratory investigations :
- Complete blood count (CBC). 2 albuminuria will be detected by dipstick kits . 3. Liver enzymes \& kidney function. 4.PT,PC,INR.
- Pelvic-Abdominal ultrasound to assess the presence of ascites Ultrasound examination will be performed by a consultant obstetrician to detect free fluid in the peritoneal cavity, especially at hepato-renal pouch, sub-splenic area, or para-colic gutters.
The presence of ascites will be further confirmed at the time of delivery.
3-All labours will be attended by an expert neonatologist and the following will be recorded:
- APGAR score at (1 min).
- The further need for neonatal intensive care unit (NICU) admission.
- Perinatal death
- Conditions
- Severe Preeclampsia
- Keywords
- preeclampsia, complications
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants developed eclampsia
convulsions in women with severe preeclampsia
Measured: 3 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start2 May 2020
- Primary completion30 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 284 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125599
- Sponsor's protocol ID
- 366
- Other IDs
- Cairo university
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Clinical, Laboratory and Ultrasonographic Findings With Development of Maternal and Neonatal Complications in Women With Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT07125599
- Acronym / sponsor ID
- 366
- Conditions
- Severe Preeclampsia
- Keywords
- preeclampsia, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 15 Aug 2025 (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.
pregnant women diagnosed with severe preeclampsia were subjected to • Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not).gravidity , parity mode of delivery any medical disorders, the presence of headache ,blurring of vision and epigastric pain.
- Complete physical examination: general (including BMI \& blood pressure measurement) and obstetric examinations.
- Routine obstetric ultrasound and Doppler indices Including umbilical artery Doppler (RI).
- Laboratory investigations :
- Complete blood count (CBC). 2 albuminuria will be detected by dipstick kits . 3. Liver enzymes \& kidney function. 4.PT,PC,INR.
- Pelvic-Abdominal ultrasound to assess the presence of ascites Ultrasound examination will be performed by a consultant obstetrician to detect free fluid in the peritoneal cavity, especially at hepato-renal pouch, sub-splenic area, or para-colic gutters.
The presence of ascites will be further confirmed at the time of delivery.
3-All labours will be attended by an expert neonatologist and the following will be recorded:
- APGAR score at (1 min).
- The further need for neonatal intensive care unit (NICU) admission.
- Perinatal death
Detailed description
pregnant women diagnosed with severe preeclampsia were subjected to • Full history taking including a detailed history of the hypertension state during the current pregnancy (onset, course, current medication, and whether the blood pressure is controlled or not).gravidity , parity mode of delivery any medical disorders, the presence of headache ,blurring of vision and epigastric pain.
- Complete physical examination: general (including BMI \& blood pressure measurement) and obstetric examinations.
- Routine obstetric ultrasound and Doppler indices Including umbilical artery Doppler (RI).
- Laboratory investigations :
- Complete blood count (CBC). 2 albuminuria will be detected by dipstick kits . 3. Liver enzymes \& kidney function. 4.PT,PC,INR.
- Pelvic-Abdominal ultrasound to assess the presence of ascites Ultrasound examination will be performed by a consultant obstetrician to detect free fluid in the peritoneal cavity, especially at hepato-renal pouch, sub-splenic area, or para-colic gutters.
The presence of ascites will be further confirmed at the time of delivery.
3-All labours will be attended by an expert neonatologist and the following will be recorded:
- APGAR score at (1 min).
- The further need for neonatal intensive care unit (NICU) admission.
- Perinatal death
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All suffering of sever preeclampsia that characterized with one or two of the following:( Dennis A. T etal2012) 1. Blood pressure of 160/110 or more. 2. Thrombocytopenia (platelet count less than 100,0000 / microliter). 3. Impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration). 4. Severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnosis, or both. 5. The new development of renal insufficiency (elevated serum creatinine> 1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease)
Key inclusion criteria (3 listed)
- Maternal age from 18 to 40 years.
- Gestational age (28_38) weeks, confirmed by the first day of the last menstrual period or first trimesteric ultrasound
- All suffering of severe preeclampsia
Key exclusion criteria (8 listed)
- known liver disease
- Maternal medical disorders rather than hypertension.
- Rupture of membrane.
- Renal disorder.
- History of illicit drug use.
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
Number of participants developed eclampsia
Time frame: 3 days after delivery
convulsions in women with severe preeclampsia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Severe Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, 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. This study is not recruiting at the moment.
Ahmed Maged, MD principal investigator
Cairo University
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 Severe Preeclampsia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants developed eclampsia (time frame: 3 days after delivery). 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 27 Aug 2025.